Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002459-41 | Other Identifier | EudraCT Number | |
| P06109 | Other Identifier | Schering-Plough | |
| MK-8175A/MK-8342B-012 | Other Identifier | Merck |
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
Not provided
The primary objective of this trial was to identify at least one next generation ring (NGR) that demonstrates inhibition of ovulation (which was considered confirmed if in the subset of participants ovulation was observed in less than 15% of the participants at any time during the 3 treatment cycles of the study) and cycle control that was non-inferior to NuvaRing®, as judged by the incidence of breakthrough bleeding and/or spotting (BTB-S) during Cycle 3. The primary hypothesis was that at least 1 of the 6 NGRs would show inhibition of ovulation and cycle control during Treatment Cycle 3 that is non-inferior to NuvaRing®, as judged by the incidence of BTB-S.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/day | Experimental | Participants will receive nomegestrol acetate 17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
|
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/day | Experimental | Participants will receive nomegestrol acetate 17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
|
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/day | Experimental | Participants will receive nomegestrol acetate 17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
|
| Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/day | Experimental | Participants will receive etonogestrel 17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nomegestrol acetate (NOMAC) | Drug | Daily release of 500, 700, or 900 μg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Ovulation Incidence, by Cycle | Ovulation was defined as having 2 or more consecutive progesterone concentrations >16 nmol/L within 5 days, confirmed by ultrasound evidence of ovulation (follicular rupture or preceding presence of a follicle-like structure >15 mm in size). | Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days) |
| Percentage of Participants With Progesterone Concentrations >16 Nmol/L, by Cycle | Maximum progesterone (Max P) was defined as the maximum progesterone value. Ovulation was defined as 2 or more consecutive progesterone concentrations >16 nmol/L within 5 days during the 3 treatment cycles, supported by ultrasound evidence of ovulation. The Max P values greater than 16 nmol/L are presented by vaginal ring group and cycle. | Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days) |
| Percentage of Participants With Breakthrough Bleeding and/or Spotting During Cycle 3 | Breakthrough bleeding and/or spotting (BTB-S) is defined as any bleeding or spotting episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Bleeding = any bloody vaginal discharge that required one or more sanitary pads or tampons per day; Spotting = any bloody vaginal discharge that required no sanitary pads or tampons per day. | Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Absence of Withdrawal Bleeding and/or Spotting During Cycle 2 | Withdrawal bleeding and/or spotting is considered any bleeding or spotting episode that starts during or continues into the expected bleeding period (i.e., when the ring has been removed the last week of the cycle). Absence of withdrawal bleeding is no withdrawal bleeding and/or spotting episodes during an expected bleeding period when the ring has been removed. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Venous or Arterial Thrombotic/Thromboembolic Events | Venous or arterial thrombotic/thrombo-embolic events, (VTEs or ATEs) (e.g., deep venous thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident) were assessed. | From Cycle 1 Day 1 up to 8 days after Day 28 of Cycle 3 (Up to ~92 days) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30203681 | Result | Duijkers I, Klipping C, Heger-Mahn D, Fayad GN, Frenkl TL, Cruz SM, Korver T. Phase II dose-finding study on ovulation inhibition and cycle control associated with the use of contraceptive vaginal rings containing 17beta-estradiol and the progestagens etonogestrel or nomegestrol acetate compared to NuvaRing. Eur J Contracept Reprod Health Care. 2018 Aug;23(4):245-254. doi: 10.1080/13625187.2018.1506101. Epub 2018 Sep 11. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Of the 757 participants who were screened for inclusion in the trial, 666 participants were randomized, and 660 participants were treated.
The study enrolled healthy female participants aged 18 to 35 years, with cycles between 24 to 35 days in length.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day | Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/day | Experimental | Participants will receive etonogestrel 17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
|
| Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/day | Experimental | Participants will receive etonogestrel 17β-estradiol (ENG-E2)125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
|
| NuvaRing® | Active Comparator | Participants will receive NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
|
| Etonogestrel (ENG) | Drug | Daily release of 75, 100, 120 or 125 μg |
|
| Ethinyl estradiol (EE) | Drug | Daily release of 15 μg |
|
| Estradiol (E2) | Drug | Daily release of 300 μg |
|
| Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 days) |
| Intensity of Withdrawal Bleeding During Cycle 2 | Intensity of withdrawal bleeding during Cycle 2 was defined as the ratio of the number of withdrawal bleeding days divided by the number of withdrawal bleeding and/or spotting days. Withdrawal bleeding and/or spotting is considered any bleeding or spotting episode that starts during or continues into the expected bleeding period (i.e., when the ring has been removed the last week of the cycle). Absence of withdrawal bleeding is no withdrawal bleeding and/or spotting episodes during an expected bleeding period when the ring has been removed. | Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 days) |
| Intensity of Breakthrough Bleeding and/or Spotting During Cycle 3 | Intensity of breakthrough bleeding and/or spotting (BTB-S) during Cycle 3 was defined as the ratio of the number of breakthrough bleeding days divided by the number of breakthrough bleeding and/or spotting days. Breakthrough bleeding and/or spotting (BTB-S) is defined as any bleeding or spotting episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Bleeding = any bloody vaginal discharge that required one or more sanitary pads or tampons per day; Spotting = any bloody vaginal discharge that required no sanitary pads or tampons per day. | Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~ 28 days) |
| Percentage of Participants Who Experienced At Least One Adverse Event | An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. | Up to ~92 days |
| Percentage of Participants Who Experienced At Least One Serious Adverse Event | A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose; or is another important medical event deemed such by medical or scientific judgment. | Up to ~92 days |
| Percentage of Participants Who Experienced At Least One Drug-Related Adverse Event | An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. A drug-related AE was defined as any AE for which there is reasonable possibility of drug relationship as assessed by the Investigator. | Up to ~92 days |
| Percentage of Participants With Any Drug-Related Serious Adverse Event | A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose; or is another important medical event deemed such by medical or scientific judgment. A drug-related SAE was defined as any SAE for which there is reasonable possibility of drug relationship as assessed by the Investigator. | Up to ~92 days |
| Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. | Up to ~92 days |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day |
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| FG002 | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| FG003 | Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| FG004 | Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| FG005 | Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| FG006 | NuvaRing® | Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
4 participants used the incorrect vaginal ring per the randomization schedule throughout the trial (2 participants in ENG-E2 125/300 μg and 1 participant each in the NOMAC-E2 900/300 μg and NuvaRing group).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day | Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| BG001 | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day | Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| BG002 | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| BG003 | Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| BG004 | Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| BG005 | Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| BG006 | NuvaRing® | Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Percentage of Participants With Ovulation Incidence, by Cycle | Ovulation was defined as having 2 or more consecutive progesterone concentrations >16 nmol/L within 5 days, confirmed by ultrasound evidence of ovulation (follicular rupture or preceding presence of a follicle-like structure >15 mm in size). | The analysis population included all participants in whom vaginal rings were inserted and received ultrasound and hormonal assessments, excluding participants who were protocol violators in terms of ring use, daily diary entry or prohibited medications. | Posted | Number | Percentage of Participants | Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days) |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Progesterone Concentrations >16 Nmol/L, by Cycle | Maximum progesterone (Max P) was defined as the maximum progesterone value. Ovulation was defined as 2 or more consecutive progesterone concentrations >16 nmol/L within 5 days during the 3 treatment cycles, supported by ultrasound evidence of ovulation. The Max P values greater than 16 nmol/L are presented by vaginal ring group and cycle. | The analysis population included all participants in whom vaginal rings were inserted and received hormonal assessment for progesterone concentration, excluding participants who were protocol violators in terms of ring use, daily diary entry or prohibited medications. | Posted | Number | Percentage of Participants | Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Breakthrough Bleeding and/or Spotting During Cycle 3 | Breakthrough bleeding and/or spotting (BTB-S) is defined as any bleeding or spotting episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Bleeding = any bloody vaginal discharge that required one or more sanitary pads or tampons per day; Spotting = any bloody vaginal discharge that required no sanitary pads or tampons per day. | The analysis population included all participants in whom vaginal rings were inserted and had an evaluable cycle with non-missing bleeding data in the respective cycle, excluding participants who were protocol violators in terms of ring use, daily diary entry or prohibited medications. | Posted | Number | Percentage of Participants | Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~28 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Absence of Withdrawal Bleeding and/or Spotting During Cycle 2 | Withdrawal bleeding and/or spotting is considered any bleeding or spotting episode that starts during or continues into the expected bleeding period (i.e., when the ring has been removed the last week of the cycle). Absence of withdrawal bleeding is no withdrawal bleeding and/or spotting episodes during an expected bleeding period when the ring has been removed. | The analysis population included all participants in whom vaginal rings were inserted and had an evaluable cycle with non-missing bleeding data in the respective cycle, excluding participants who were protocol violators in terms of ring use, daily diary entry or prohibited medications. | Posted | Number | Percentage of Participants | Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Intensity of Withdrawal Bleeding During Cycle 2 | Intensity of withdrawal bleeding during Cycle 2 was defined as the ratio of the number of withdrawal bleeding days divided by the number of withdrawal bleeding and/or spotting days. Withdrawal bleeding and/or spotting is considered any bleeding or spotting episode that starts during or continues into the expected bleeding period (i.e., when the ring has been removed the last week of the cycle). Absence of withdrawal bleeding is no withdrawal bleeding and/or spotting episodes during an expected bleeding period when the ring has been removed. | The analysis population included all participants in whom vaginal rings were inserted and had an evaluable cycle with non-missing bleeding data in the respective cycle, and with at least one withdrawal bleeding or spotting day, excluding participants who were protocol violators in terms of ring use, daily diary entry or prohibited medications. | Posted | Mean | Standard Deviation | Ratio | Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 days) |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Intensity of Breakthrough Bleeding and/or Spotting During Cycle 3 | Intensity of breakthrough bleeding and/or spotting (BTB-S) during Cycle 3 was defined as the ratio of the number of breakthrough bleeding days divided by the number of breakthrough bleeding and/or spotting days. Breakthrough bleeding and/or spotting (BTB-S) is defined as any bleeding or spotting episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Bleeding = any bloody vaginal discharge that required one or more sanitary pads or tampons per day; Spotting = any bloody vaginal discharge that required no sanitary pads or tampons per day. | The analysis population included all participants in whom vaginal rings were inserted and had an evaluable cycle with non-missing bleeding data in the respective cycle, and with at least one breakthrough bleeding and/or spotting day, excluding protocol violators in terms of ring use, daily diary entry or prohibited medications. | Posted | Mean | Standard Deviation | Ratio | Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~ 28 days) |
| |||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Venous or Arterial Thrombotic/Thromboembolic Events | Venous or arterial thrombotic/thrombo-embolic events, (VTEs or ATEs) (e.g., deep venous thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident) were assessed. | The analysis population included all randomized participants in whom a vaginal ring was inserted. | Posted | Count of Participants | Participants | From Cycle 1 Day 1 up to 8 days after Day 28 of Cycle 3 (Up to ~92 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced At Least One Adverse Event | An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. | The analysis population included all randomized participants in whom a vaginal ring was inserted. | Posted | Number | Percentage of Participants | Up to ~92 days |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced At Least One Serious Adverse Event | A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose; or is another important medical event deemed such by medical or scientific judgment. | The analysis population included all randomized participants in whom a vaginal ring was inserted. | Posted | Number | Percentage of Participants | Up to ~92 days |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced At Least One Drug-Related Adverse Event | An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. A drug-related AE was defined as any AE for which there is reasonable possibility of drug relationship as assessed by the Investigator. | The analysis population included all randomized participants in whom a vaginal ring was inserted. | Posted | Number | Percentage of Participants | Up to ~92 days |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Any Drug-Related Serious Adverse Event | A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose; or is another important medical event deemed such by medical or scientific judgment. A drug-related SAE was defined as any SAE for which there is reasonable possibility of drug relationship as assessed by the Investigator. | The analysis population included all randomized participants in whom a vaginal ring was inserted. | Posted | Number | Percentage of Participants | Up to ~92 days |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. | The analysis population included all randomized participants in whom a vaginal ring was inserted. | Posted | Number | Percentage of Participants | Up to ~92 days |
|
Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
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 | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day | Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. | 0 | 79 | 0 | 79 | 23 | 79 |
| EG001 | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day | Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. | 0 | 85 | 0 | 85 | 20 | 85 |
| EG002 | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. | 0 | 78 | 0 | 78 | 26 | 78 |
| EG003 | Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. | 0 | 77 | 0 | 77 | 24 | 77 |
| EG004 | Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. | 0 | 77 | 0 | 77 | 22 | 77 |
| EG005 | Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. | 0 | 86 | 0 | 86 | 25 | 86 |
| EG006 | NuvaRing® | Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. | 0 | 178 | 0 | 178 | 46 | 178 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| C038501 | nomegestrol acetate |
| C044815 | etonogestrel |
| D004997 | Ethinyl Estradiol |
| D004958 | Estradiol |
| ID | Term |
|---|---|
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D004963 | Estrenes |
| D004962 | Estranes |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Cycle 2 |
|
| Cycle 3 |
|
| OG002 | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG003 | Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG004 | Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG005 | Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG006 | NuvaRing® | Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
|
|
| OG002 | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG003 | Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG004 | Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG005 | Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG006 | NuvaRing® | Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
|
|
|
| OG002 | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG003 | Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG004 | Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG005 | Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG006 | NuvaRing® | Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
|
|
|
| OG002 | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG003 | Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG004 | Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG005 | Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG006 | NuvaRing® | Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
|
|
|
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
| OG002 | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG003 | Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG004 | Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG005 | Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG006 | NuvaRing® | Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
|
|
|
| OG003 | Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG004 | Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG005 | Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG006 | NuvaRing® | Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
|
|
| OG003 | Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG004 | Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG005 | Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG006 | NuvaRing® | Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
|
|
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG003 | Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG004 | Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG005 | Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG006 | NuvaRing® | Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
|
|
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG003 | Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG004 | Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG005 | Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG006 | NuvaRing® | Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
|
|
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day |
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG003 | Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG004 | Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG005 | Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG006 | NuvaRing® | Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
|
|
| OG003 | Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG004 | Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG005 | Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| OG006 | NuvaRing® | Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
|
|
|
|