| Primary | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain. | Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes from baseline to cycle 4. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | score on a scale | | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | Vaginal ring containing matching placebo Placebo: Matching placebo |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-0.66± 1.213
- OG001-2.04± 2.092
- OG002-2.14± 1.344
- OG003
|
|
| |
| Secondary | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain on Days With Menstrual Bleeding and for the Worst Endometriosis-related Pain on Days With no Menstrual Bleeding | Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Days with menstrual bleeding (dysmenorrhea). No menstrual bleeding (non-menstrual pelvic pain) Changes from baseline to cycle 4 | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | score on a scale | | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases |
|
| Secondary | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain. | Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | score on a scale | | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases |
|
| Secondary | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea. | Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | score on a scale | | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | |
|
| Secondary | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain. | Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | score on a scale | | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases |
|
| Secondary | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dyspareunia on Days With Sexual Intercourse. | Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | score on a scale | | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases |
|
| Secondary | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | The participants recorded daily if they had sexual intercourse, in an e-diary. For the days when participants did not have intercourse, the participant recorded if the reason for not having intercourse was because they expected pain: "Yes" (I did not have intercourse this day, because I expected pain) or "No" (I did not have intercourse this day, but this was not because I expected pain). The numbers represent the cumulative number of days with no intercourse, summed across all participants. In some cases, there are missing data as not every participant completed the e-diary for 100% of study days. | | Posted | | Number | | Number of days | | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases |
|
| Secondary | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function. | Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | score on a scale | | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases |
|
| Secondary | Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain. | Assessed weekly by participants in an e-Diary. EHP-30 is a quality-of-life questionnaire. Score ranges from 0-100 and lower score denotes improvement. Changes over 4 menstrual cycles. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | score on a scale | | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases |
|
| Secondary | Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period | The participants recorded daily if they had any vaginal bleeding during the past 24 hours, in an e-diary. Of the participants who had a bleeding, the participant recorded if this was menstrual bleeding: "Yes" (I had a vaginal bleeding that was menstrual bleeding) or "No" (I had a vaginal bleeding that was not menstrual bleeding). The numbers represent the cumulative number of days with vaginal bleeding, summed across all participants. In some cases, there are missing data as not every participant completed the e-diary for 100% of study days. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Number | | Number of days | | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg |
|
| Secondary | Changes in Vaginal Bleeding Pattern. | The participants recorded daily if they had any vaginal bleeding during the past 24 hours, in an e-diary. Of the participants who had a bleeding, the participant recorded the assessed bleeding volume as either spotting (tiny amount of blood on underwear or panty liners), light bleeding (requiring 1-3 sanitary pads or tampons per day), moderate bleeding (requiring 4-6 sanitary pads or tampons per day), or heavy bleeding (requiring more than 6 sanitary pads or tampons per day). The numbers represent the cumulative number of days with vaginal bleeding, summed across all participants. In some cases, there are missing data as not every participant completed the e-diary for 100% of study days. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Number | | Number of days | | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | |
|
| Secondary | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Assessed daily by participants in an e-Diary | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | percentage of days | | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Assessed daily by participants in an e-Diary | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mg | | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Responder Rate | Assessed as ≥30%, ≥50% and ≥70% reduction from the baseline in mean daily NRS score for the worst endometriosis-related pain, dysmenorrhea and non-menstrual pelvic pain and for the worst endometriosis-related pain impact | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 |
|
| Secondary | Changes in the Mean Individual and Total Symptom and Sign Severity Scores | Assessed by the Biberoglu and Behrman (B&B) scale which is a 4-point scale with 0=none and 3=severe. The scores are the mean individual scores. The B&B scale consists of two parts. The first part of the B&B scale evaluates symptoms of endometriosis (i.e. pain). There are 3 subscales: pelvic pain(A, 0=none and 3=severe), dysmenorrhea (B, 0=none and 3=severe), and dyspareunia(C, 0=none and 3=severe). The total pelvic pain score is the sum of the three scores, i.e. A+B+C, which can range from 0 to 9. The second part of the B&B scale evaluates signs of endometriosis. There are 2 subscales pelvic tenderness (D, 0=none and 3=severe) and induration (E, 0=none and 3=severe) based on findings from a pelvic examination. The total physical pain score is the sum of the two scores, i.e. D+E, which can range from 0 to 6. The total symptom and sign severity score is the sum of all five scores, i.e. A+B+C+D+E, which can range from 0 to 15. The values are the change from baseline to cycle 4. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | score on a scale | | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg |
|
| Secondary | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores | Assessed by the EHP-30 quality-of-life questionnaire completed by participants. Score ranges from 0-100 with lower score denoting improvement. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | score on a scale | | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 |
|
| Secondary | Changes in Patient Global Impression of Severity (PGIS) Scores | Assessed by the PGIS scale completed by participants. PGIS is a 6-point scale depicting a participant's rating of their current conditions from "good" to "bad". It ranges from 0 (none) to 5 (very severe). | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | |
|
| Secondary | Patient Global Impression of Change (PGIC) Scores | Assessed by the PGIC scale completed by participants. PGIC is a 7-point scale depicting a patient's rating of their overall improvement from "good" to "bad". | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | At cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 |
|
| Secondary | Plasma Concentration of Quinagolide and Metabolites | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | pg/mL | | Within 5 days after first ring insertion and at around 1 month, 3 months, 3.5 months and 4 months after baseline (each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases |
| |
| Secondary | Serum Levels of Mid-luteal Phase Progesterone | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | ng/mL | | At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml) | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Serum Levels of Estradiol | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | pmol/L | | At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | Vaginal ring containing matching placebo Placebo: Matching placebo |
|
| Secondary | Serum Levels of Prolactin | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | ng/mL | | At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | Vaginal ring containing matching placebo Placebo: Matching placebo |
|
| Secondary | Serum Levels of Thyrotropin (TSH) | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | uIU/mL | | At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | Vaginal ring containing matching placebo Placebo: Matching placebo |
|
| Secondary | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | ng/mL | | At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Bone Turnover Markers, Determined by Bone Resorption Marker Serum C-terminal Crosslinking Telopeptide of Type 1 Collagen (s-CTx) | Assessed by blood samples collection. Changes from baseline to cycle 4 | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | ng/mL | | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 |
|
| Secondary | Changes in Bone Turnover Markers, Determined by Bone Formation Marker Serum Procollagen Type I N Propeptide (s-PINP) | Assessed by blood samples collection. Changes from baseline to cycle 4 | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | ng/mL | | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo |
|
| Secondary | Changes in ECG Parameters Including PR Interval at Cycle 4 | | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | msec | | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in ECG Parameters Including QRS Duration at Cycle 4 | | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | msec | | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in ECG Parameters Including QT Interval at Cycle 4 | | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | msec | | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in ECG Parameters Including QTcF Interval at Cycle 4 | | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | msec | | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Proportion of Subjects With Abnormal Clinically Significant Echocardiography Findings Indicating Valvular Heart Disease | Assessed by echocardiography. Each echocardiography was to be assessed as normal or abnormal according to American College of Cardiology/American Heart Association guidelines for valvular heart disease. If abnormal, the level of valvular regurgitation and valvular stenosis was specified as mild, moderate or severe and valvular structure was evaluated as well. Measured at cycle 4. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases |
|
| Secondary | Proportion of Subjects Identified With Potential Impulse Control Disorders | Assessed by the questionnaire for impulsive-compulsive disorders completed by participants. Measured at cycle 4. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 |
|
| Secondary | Frequency and Intensity of Adverse Events | Assessed by an Adverse Events Log completed by the Investigator | | Posted | | Number | | participants | | From signing informed consent through study completion, around 8 months | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | Vaginal ring containing matching placebo Placebo: Matching placebo |
| |
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters: Albumin | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | g/L | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters: Alkaline Phosphatase | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | IU/L | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters: Alanine Aminotransferase | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | IU/L | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters: Aspartate Aminotransferase | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | IU/L | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters: Bicarbonate | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters: Direct Bilirubin | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | umol/L | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters: Bilirubin | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | umol/L | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters: Calcium | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters: Cholesterol | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters: Chloride | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters: Creatinine | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | umol/L | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters: Gamma Glutamyl Transferase | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | IU/L | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters: Glucose | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters: Potassium | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters: Lactate Dehydrogenase | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | IU/L | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters: Phosphate | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters: Protein | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | g/L | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters: Sodium | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters: Urate | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | umol/L | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters: Urea Nitrogen | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Haematology Parameters: Basophils Absolute | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Basophils Absolute (%) | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Haematology Parameters: Basophils | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | *10^3 cells/uL | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Haematology Parameters: Eosinophils Absolute | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Eosinophils Absolute (%) | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Haematology Parameters: Eosinophils | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | *10^3 cells/uL | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Haematology Parameters: Hematocrit | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | RATIO | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Haematology Parameters: Hemoglobin | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | g/L | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Haematology Parameters: Lymphocytes Absolute | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Lymphocytes Absolute (%) | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Haematology Parameters: Lymphocytes | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | *10^3 cells/uL | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular Hemoglobin | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | pg/cell | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular HGB Concentration | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular Volume | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | fL | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Haematology Parameters: Monocytes Absolute | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Monocytes Absolute (%) | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Haematology Parameters: Monocytes | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | *10^3 cells/uL | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Haematology Parameters: Neutrophils Absolute | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Neutrophils Absolute (%) | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Haematology Parameters: Neutrophils | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | *10^3 cells/uL | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Haematology Parameters: Platelets | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Haematology Parameters: Erythrocytes | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | 10^12 cells/L | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Haematology Parameters: Leukocytes | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Urinalysis Parameters (Protein, Glucose, Bilirubin, pH, Nitrite, Ketone, Urobilinogen, Blood, Leukocytes, and Specific Gravity) | Assessed by urine sample collection (dip-stick test). Overall Urinalysis Result. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 |
|
| Secondary | Proportion of Subjects With Markedly Abnormal Changes in Circulating Levels of Clinical Chemistry Parameters | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Proportion of Subjects With Markedly Abnormal Changes in Circulating Levels of Clinical Haematology Parameters | Assessed by blood samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | At baseline and at menstrual cycle 4 (around 4 months) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Proportion of Subjects With Markedly Abnormal Changes in Urinalysis Parameters | Assessed by urine samples collection | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo | |
|
| Secondary | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Assessed by a questionnaire completed by participants, addressing ring insertion | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo |
|
| Secondary | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Assessed by a questionnaire completed by participants, addressing ring removal. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 | Placebo |
|
| Secondary | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Assessed by a questionnaire completed by participants, addressing any feeling of the ring while the ring is in the body. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Quinagolide 360 µg | Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | | OG001 | Quinagolide 720 µg | Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | | OG002 | Quinagolide 1080 µg | Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | | OG003 |
|