Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This will be a randomized, double-blind, placebo-controlled, proof-of-mechanism phase 2 trial investigating the effect of quinagolide extended-release vaginal ring on reduction of lesions assessed by high-resolution magnetic resonance imaging in women with endometrioma, deep infiltrating endometriosis, and/or adenomyosis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quinagolide 1080 µg | Experimental | Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg. |
|
| Placebo | Placebo Comparator | Vaginal ring containing matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quinagolide 1080 µg | Drug | Vaginal ring containing Quinagolide 1080 µg for daily releases |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4 | The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. At screening, every measurable lesion (defined as ≥10 mm in size) of any type was recorded and was summed up by type for primary analysis. | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Compliance | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gyneacology Rigshospitalet | Copenhagen | Denmark | ||||
| Charité Universitätsmedizin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40188683 | Derived | Pellicer A, Taylor HS, Alberich-Bayarri A, Liu Y, Gamborg M, Barletta KE, Pinton P, Heiser PW, Bagger YZ. Quinagolide vaginal ring for reduction of endometriotic lesions: Results from the QLARITY trial. Eur J Obstet Gynecol Reprod Biol. 2025 Jun;310:113946. doi: 10.1016/j.ejogrb.2025.113946. Epub 2025 Mar 30. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In total, 147 subjects were screened. Of these, 80 were screening failures and 67 were randomized and exposed to the investigational medicinal product (IMP): 35 to Quinagolide and 32 to Placebo.
The trial was performed in 6 investigational sites in 3 countries between Aug 2019 to Jul 2021.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo | Vaginal ring containing matching placebo Placebo: Matching placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4 | The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. At screening, every measurable lesion (defined as ≥10 mm in size) of any type was recorded and was summed up by type for primary analysis. | All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified. | Posted | Least Squares Mean | Standard Error | mm | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
Adverse events were recorded for each participant from the time of signed informed consent for participation in the trial to follow-up visit (approximately 1 month after visit 8 (month 4), up to 5 months).
All adverse events with onset after start of first administration of IMP and before the follow-up phone call were considered treatment-emergent.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Compliance | Ferring Pharmaceuticals | - | DK0-Disclosure@ferring.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 12, 2019 | Jun 21, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 26, 2021 | Jun 21, 2022 | SAP_001.pdf |
Not provided
Not provided
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D062788 | Adenomyosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C046650 | quinagolide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Matching placebo |
|
| Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4 |
The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. |
| At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4 | The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in the Volumes (mm3) of Endometrioma and DIE Lesions Summed by Type on MR Images at Cycle 4 | The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in the Sizes of Endometrioma Assessed by Transvaginal Ultrasound (TVU) at Cycle 4 | Transvaginal ultrasound (TVU) will be performed, preferably by the same sonographer, at the screening visit and at end-of-treatment / cycle 4. | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) |
| Changes in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&B) Scale at Cycle 4 | B&B scale is a used scale for endometriosis that consists of two parts, with the first part evaluating symptoms (i.e. different types of pain) and the second part evaluating physical signs. In the first part, the subject was asked to grade her pelvic pain (item A), dysmenorrhea (item B) and dyspareunia (item C) during the last menstrual cycle as none, mild, moderate or severe, corresponding to a score of 0-3. In the second part, the investigator graded the subject's pelvic tenderness (item D) and induration (item E) based on findings from a pelvic examination as none, mild, moderate or severe, corresponding to a score of 0-3. The total symptom and sign severity score was the sum of all five scores, i.e. A+B+C+D+E. The score can be between 0 and 15. | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) |
| Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | Assessed by Subjects. NRS is a 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Subjects were asked to score the worst pain in relation to endometriosis / adenomyosis on the NRS based on a recall of their experiences during the following timeframes:
| At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months) |
| Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4 | EHP-30 is a quality-of-life questionnaire. Score ranges from 0-100 and lower score denotes improvement. It consists of 30 questions measuring the frequency of the endometriosis impact on their quality of life during the past four weeks, with five options of never, rarely, sometimes, often and always. | At baseline, at menstrual cycles 2 (~2 months) and 4 (~4 months) |
| Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | Assessed by subject self-reported answers to menstrual bleeding questions. The Menstrual Cycle Duration is shown. | At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months) |
| Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | Assessed by subject self-reported answers to menstrual bleeding questions. The Menstrual Bleeding Duration is shown. | At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months) |
| Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4 | Assessed by blood sample collection | Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months) |
| Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4 | Assessed by blood sample collection | Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months) |
| Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4 | Assessed by blood sample collection | Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months) |
| Plasma Concentrations of Quinagolide and Its Metabolites During Cycles 1 to 4 | Assessed by blood sample collection | Within 1-5 days post randomization, within 7-14 days post randomization, and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months) |
| Changes in Clinical Chemistry and Hematology Parameters: Hematocrit | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in Clinical Chemistry and Hematology Parameters: Hemaglobin | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Hemoglobin | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular HGB Concentration | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Volume | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in Clinical Chemistry and Hematology Parameters: Platelets | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in Clinical Chemistry and Hematology Parameters: Erythrocytes | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in Clinical Chemistry and Hematology Parameters: Leukocytes | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in Clinical Chemistry and Hematology Parameters: Alanine Aminotransferase | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in Clinical Chemistry and Hematology Parameters: Albumin | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in Clinical Chemistry and Hematology Parameters: Alkaline Phosphatase | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in Clinical Chemistry and Hematology Parameters: Aspartate Aminotransferase | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in Clinical Chemistry and Hematology Parameters: Bicarbonate | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in Clinical Chemistry and Hematology Parameters: Direct Bilirubin | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in Clinical Chemistry and Hematology Parameters: Bilirubin | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in Clinical Chemistry and Hematology Parameters: Calcium | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in Clinical Chemistry and Hematology Parameters: Chloride | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in Clinical Chemistry and Hematology Parameters: Cholesterol | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in Clinical Chemistry and Hematology Parameters: Creatinine | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in Clinical Chemistry and Hematology Parameters: Gamma Glutamyl Transferase | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in Clinical Chemistry and Hematology Parameters: Glucose | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in Clinical Chemistry and Hematology Parameters: Lactate Dehydrogenase | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in Clinical Chemistry and Hematology Parameters: Phosphate | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in Clinical Chemistry and Hematology Parameters: Potassium | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in Clinical Chemistry and Hematology Parameters: Sodium | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in Clinical Chemistry and Hematology Parameters: Protein | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in Clinical Chemistry and Hematology Parameters: Urate | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Changes in Clinical Chemistry and Hematology Parameters: Urea Nitrogen | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Proportion of Subjects With Markedly Abnormal Changes in Clinical Chemistry and Hematology Parameters | Assessed by blood sample collection | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
| Frequency and Intensity of Adverse Events | Assessed by and Adverse Event Log completed by the Investigator | From obtaining the informed consent to end of trial (up to 6 menstrual cycles ~ around 6 months, each cycle is approximately 28 days) |
| Berlin |
| Germany |
| Universitätsklinikum Carl Gustav Carus | Dresden | Germany |
| Universitätsklinikum Münster | Münster | Germany |
| Azienda Opsedaliera Universitaria Careggi | Florence | Italy |
| Università degli Studi di Roma La Sapienza | Rome | Italy |
| Azienda Ospedaliera Universitaria Senese | Siena | Italy |
| Azienda Ospedaliera Universitaria Integrata Verona | Verona | Italy |
| Centrum Medyczne PROMED | Krakow | Poland |
| Gabinet Lekarski Specjalistyczny SONUS | Warsaw | Poland |
| Specjalistyczny Gabinet Lekarski | Warsaw | Poland |
Vaginal ring containing matching placebo
Placebo: Matching placebo
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| OG000 |
| 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 |
| OG001 | Placebo | Vaginal ring containing matching placebo Placebo: Matching placebo |
|
|
|
| Secondary | Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. | All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified. | Posted | Mean | Standard Deviation | Percentage of changes in the size | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
|
| Secondary | Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4 | The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. | All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified. | Posted | Number | Percentage of lesions | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Lesions | Lesions |
|
|
|
|
| Secondary | Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4 | The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. | All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified. | Posted | Number | Percentage of subjects | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
|
| Secondary | Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. | All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified. | Posted | Number | Lesions | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
|
| Secondary | Changes in the Volumes (mm3) of Endometrioma and DIE Lesions Summed by Type on MR Images at Cycle 4 | The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. | All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, and 45 subjects in the DIE group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified. | Posted | Least Squares Mean | Standard Error | mm^3 | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
|
| Secondary | Changes in the Sizes of Endometrioma Assessed by Transvaginal Ultrasound (TVU) at Cycle 4 | Transvaginal ultrasound (TVU) will be performed, preferably by the same sonographer, at the screening visit and at end-of-treatment / cycle 4. | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | mm | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) |
|
|
|
|
| Secondary | Changes in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&B) Scale at Cycle 4 | B&B scale is a used scale for endometriosis that consists of two parts, with the first part evaluating symptoms (i.e. different types of pain) and the second part evaluating physical signs. In the first part, the subject was asked to grade her pelvic pain (item A), dysmenorrhea (item B) and dyspareunia (item C) during the last menstrual cycle as none, mild, moderate or severe, corresponding to a score of 0-3. In the second part, the investigator graded the subject's pelvic tenderness (item D) and induration (item E) based on findings from a pelvic examination as none, mild, moderate or severe, corresponding to a score of 0-3. The total symptom and sign severity score was the sum of all five scores, i.e. A+B+C+D+E. The score can be between 0 and 15. | All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified. | Posted | Mean | Standard Deviation | score on a scale | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) |
|
|
|
|
| Secondary | Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | Assessed by Subjects. NRS is a 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Subjects were asked to score the worst pain in relation to endometriosis / adenomyosis on the NRS based on a recall of their experiences during the following timeframes:
| All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified. | Posted | Mean | Standard Deviation | score on a scale | At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months) |
|
|
|
|
| Secondary | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4 | EHP-30 is a quality-of-life questionnaire. Score ranges from 0-100 and lower score denotes improvement. It consists of 30 questions measuring the frequency of the endometriosis impact on their quality of life during the past four weeks, with five options of never, rarely, sometimes, often and always. | All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified. | Posted | Mean | Standard Deviation | Score on a scale | At baseline, at menstrual cycles 2 (~2 months) and 4 (~4 months) |
|
|
|
|
| Secondary | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | Assessed by subject self-reported answers to menstrual bleeding questions. The Menstrual Cycle Duration is shown. | All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified. | Posted | Mean | Standard Deviation | Days | At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months) |
|
|
|
| Secondary | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | Assessed by subject self-reported answers to menstrual bleeding questions. The Menstrual Bleeding Duration is shown. | All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified. | Posted | Mean | Standard Deviation | Days | At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months) |
|
|
|
| Secondary | Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4 | Assessed by blood sample collection | All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified. | Posted | Mean | Standard Deviation | pg/L | Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months) |
|
|
|
| Secondary | Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4 | Assessed by blood sample collection | All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified. | Posted | Mean | Standard Deviation | mIU/L | Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months) |
|
|
|
| Secondary | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4 | Assessed by blood sample collection | All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified. | Posted | Mean | Standard Deviation | nmol/L | Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months) |
|
|
|
| Secondary | Plasma Concentrations of Quinagolide and Its Metabolites During Cycles 1 to 4 | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | pg/mL | Within 1-5 days post randomization, within 7-14 days post randomization, and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Hematocrit | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | % v/v | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Hemaglobin | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | g/L | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Hemoglobin | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | pg/cell | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular HGB Concentration | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | g/L | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Volume | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | fL | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Platelets | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | 10^9 cells/L | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Erythrocytes | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | 10^12 cells/L | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Leukocytes | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | 10^9 cells/L | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Alanine Aminotransferase | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | U/L | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Albumin | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | g/L | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Alkaline Phosphatase | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | IU/L | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Aspartate Aminotransferase | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | U/L | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Bicarbonate | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmol/L | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Direct Bilirubin | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | umol/L | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Bilirubin | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | umol/L | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Calcium | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmol/L | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Chloride | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmol/L | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Cholesterol | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmol/L | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Creatinine | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | umol/L | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Gamma Glutamyl Transferase | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | U/L | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Glucose | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmol/L | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Lactate Dehydrogenase | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | U/L | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Phosphate | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmol/L | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Potassium | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmol/L | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Sodium | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmol/L | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Protein | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | g/L | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Urate | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | umol/L | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Changes in Clinical Chemistry and Hematology Parameters: Urea Nitrogen | Assessed by blood sample collection | Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmol/L | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Proportion of Subjects With Markedly Abnormal Changes in Clinical Chemistry and Hematology Parameters | Assessed by blood sample collection | Posted | Number | Percentage of subjects | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) |
|
|
|
| Secondary | Frequency and Intensity of Adverse Events | Assessed by and Adverse Event Log completed by the Investigator | Posted | Number | Percentage of subjects | From obtaining the informed consent to end of trial (up to 6 menstrual cycles ~ around 6 months, each cycle is approximately 28 days) |
|
|
|
| 0 |
| 35 |
| 1 |
| 35 |
| 20 |
| 35 |
| EG001 | Placebo | Vaginal ring containing matching placebo Placebo: Matching placebo | 0 | 32 | 0 | 32 | 20 | 32 |
| Abdominal distension | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Corona virus infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
|
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
| D000091662 | Genital Diseases |
| D014591 | Uterine Diseases |
| DIE |
|
|
| Adenomyosis |
|
|
| ANCOVA |
ANCOVA adjusted for baseline lesion size. |
| 0.92 |
| Difference in LS mean |
| -1.13 |
| 2-Sided |
| 95 |
| -22.77 |
| 20.51 |
| Other |
| ANCOVA | ANCOVA adjusted for baseline lesion size. | 0.74 | Difference in LS mean | -5.92 | 2-Sided | 95 | -40.94 | 29.10 | Other |
|
| DIE |
|
|
| Adenomyosis |
|
|
| 0.39 |
| Odds Ratio (OR) |
| 0.55 |
| 2-Sided |
| 95 |
| 0.14 |
| 2.17 |
| Other |
| DIE |
|
|
| Adenomyosis |
|
|
| 0.21 |
| Odds Ratio (OR) |
| 0.35 |
| 2-Sided |
| 95 |
| 0.07 |
| 1.79 |
| Other |
| Adenomyosis - Disappearing Lesions |
|
| Endometrioma - New Lesions |
|
| DIE - New Lesions |
|
| Adenomyosis - New Lesions |
|
| 0.56 |
| Rate Ratio |
| 0.49 |
| 2-Sided |
| 95 |
| 0.04 |
| 5.41 |
| Other |
| DIE |
|
|
| ANCOVA |
ANCOVA adjusted for baseline lesion size. |
| 0.74 |
| Difference in LS mean |
| 0.72 |
| 2-Sided |
| 95 |
| -3.63 |
| 5.07 |
| Other |
| DIE |
|
|
| Adenomyosis |
|
|
| ANCOVA |
ANCOVA adjusted for baseline lesion size. |
| 0.67 |
| Difference in LS mean |
| 0.28 |
| 2-Sided |
| 95 |
| -1.02 |
| 1.58 |
| Other |
| Adenomyosis | ANCOVA | ANCOVA adjusted for baseline lesion size. | 0.64 | Difference in LS mean | 0.32 | 2-Sided | 95 | -1.06 | 1.71 | Other |
| Endometrioma at cycle 2 |
|
|
| Endometrioma at cycle 3 |
|
|
| Endometrioma at cycle 4 |
|
|
| DIE at cycle 1 |
|
|
| DIE at cycle 2 |
|
|
| DIE at cycle 3 |
|
|
| DIE at cycle 4 |
|
|
| Adenomyosis at cycle 1 |
|
|
| Adenomyosis at cycle 2 |
|
|
| Adenomyosis at cycle 3 |
|
|
| Adenomyosis at cycle 4 |
|
|
| ANCOVA |
ANCOVA adjusted for baseline lesion size. |
| 0.54 |
| Difference in LS mean |
| 0.42 |
| 2-Sided |
| 95 |
| -0.97 |
| 1.82 |
| Other |
| Endometrioma at cycle 3 | ANCOVA | ANCOVA adjusted for baseline lesion size. | 0.46 | Difference in LS mean | -0.50 | 2-Sided | 95 | -1.86 | 0.85 | Other |
| Endometrioma at cycle 4 | ANCOVA | ANCOVA adjusted for baseline lesion size. | 0.49 | Difference in LS mean | 0.53 | 2-Sided | 95 | -0.99 | 2.05 | Other |
| DIE at cycle 1 | ANCOVA | ANCOVA adjusted for baseline lesion size. | 0.99 | Difference in LS mean | -0.01 | 2-Sided | 95 | -1.32 | 1.30 | Other |
| DIE at cycle 2 | ANCOVA | ANCOVA adjusted for baseline lesion size. | 0.83 | Difference in LS mean | 0.17 | 2-Sided | 95 | -1.38 | 1.71 | Other |
| DIE at cycle 3 | ANCOVA | ANCOVA adjusted for baseline lesion size. | 0.28 | Difference in LS mean | -0.74 | 2-Sided | 95 | -2.11 | 0.63 | Other |
| DIE at cycle 4 | ANCOVA | ANCOVA adjusted for baseline lesion size. | 0.26 | Difference in LS mean | 0.75 | 2-Sided | 95 | -0.57 | 2.07 | Other |
| Adenomyosis at cycle 1 | ANCOVA | ANCOVA adjusted for baseline lesion size. | 0.19 | Difference in LS mean | 0.91 | 2-Sided | 95 | -0.49 | 2.31 | Other |
| Adenomyosis at cycle 2 | ANCOVA | ANCOVA adjusted for baseline lesion size. | 0.93 | Difference in LS mean | 0.07 | 2-Sided | 95 | -1.45 | 1.58 | Other |
| Adenomyosis at cycle 3 | ANCOVA | ANCOVA adjusted for baseline lesion size. | 0.85 | Difference in LS mean | -0.13 | 2-Sided | 95 | -1.58 | 1.32 | Other |
| Adenomyosis at cycle 4 | ANCOVA | ANCOVA adjusted for baseline lesion size. | 0.99 | Difference in LS mean | 0.01 | 2-Sided | 95 | -1.68 | 1.69 | Other |
| Endometrioma at cycle 4 |
|
|
| DIE at cycle 2 |
|
|
| DIE at cycle 4 |
|
|
| Adenomyosis at cycle 2 |
|
|
| Adenomyosis at cycle 4 |
|
|
| ANCOVA |
ANCOVA adjusted for baseline lesion size. |
| 0.42 |
| Difference in LS mean |
| 17.31 |
| 2-Sided |
| 95 |
| -25.41 |
| 60.04 |
| Other |
| DIE at cycle 2 | ANCOVA | ANCOVA adjusted for baseline lesion size. | 0.47 | Difference in LS mean | -17.66 | 2-Sided | 95 | -66.30 | 30.98 | Other |
| DIE at cycle 4 | ANCOVA | ANCOVA adjusted for baseline lesion size. | 0.27 | Difference in LS mean | 25.61 | 2-Sided | 95 | -21.05 | 72.27 | Other |
| Adenomyosis at cycle 2 | ANCOVA | ANCOVA adjusted for baseline lesion size. | 0.41 | Difference in LS mean | -20.95 | 2-Sided | 95 | -71.83 | 29.92 | Other |
| Adenomyosis at cycle 4 | ANCOVA | ANCOVA adjusted for baseline lesion size. | 0.93 | Difference in LS mean | 2.25 | 2-Sided | 95 | -49.57 | 54.06 | Other |
| Endometrioma at cycle 1 |
|
|
| Endometrioma at cycle 2 |
|
|
| Endometrioma at cycle 3 |
|
|
| Endometrioma at cycle 4 |
|
|
| DIE at baseline |
|
|
| DIE at cycle 1 |
|
|
| DIE at cycle 2 |
|
|
| DIE at cycle 3 |
|
|
| DIE at cycle 4 |
|
|
| Adenomyosis at baseline |
|
|
| Adenomyosis at cycle 1 |
|
|
| Adenomyosis at cycle 2 |
|
|
| Adenomyosis at cycle 3 |
|
|
| Adenomyosis at cycle 4 |
|
|
| Endometrioma at cycle 1 |
|
|
| Endometrioma at cycle 2 |
|
|
| Endometrioma at cycle 3 |
|
|
| Endometrioma at cycle 4 |
|
|
| DIE at baseline |
|
|
| DIE at cycle 1 |
|
|
| DIE at cycle 2 |
|
|
| DIE at cycle 3 |
|
|
| DIE at cycle 4 |
|
|
| Adenomyosis at baseline |
|
|
| Adenomyosis at cycle 1 |
|
|
| Adenomyosis at cycle 2 |
|
|
| Adenomyosis at cycle 3 |
|
|
| Adenomyosis at cycle 4 |
|
|
| Endometrioma at cycle 2 |
|
|
| Endometrioma at cycle 4 |
|
|
| DIE at cycle 1 |
|
|
| DIE at cycle 2 |
|
|
| DIE at cycle 4 |
|
|
| Adenomyosis at cycle 1 |
|
|
| Adenomyosis at cycle 2 |
|
|
| Adenomyosis at cycle 4 |
|
|
| Endometrioma at cycle 2 |
|
|
| Endometrioma at cycle 4 |
|
|
| DIE at cycle 1 |
|
|
| DIE at cycle 2 |
|
|
| DIE at cycle 4 |
|
|
| Adenomyosis at cycle 1 |
|
|
| Adenomyosis at cycle 2 |
|
|
| Adenomyosis at cycle 4 |
|
|
| Endometrioma at cycle 2 |
|
|
| Endometrioma at cycle 4 |
|
|
| DIE at cycle 1 |
|
|
| DIE at cycle 2 |
|
|
| DIE at cycle 4 |
|
|
| Adenomyosis at cycle 1 |
|
|
| Adenomyosis at cycle 2 |
|
|
| Adenomyosis at cycle 4 |
|
|
|
| Cycle 1 |
|
|
| Cycle 2 |
|
|
| Cycle 3 |
|
|
| Cycle 4 |
|
|
| Severe adverse events |
|