Trial · NCT01709318
A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings (P06109/MK-8175A/MK-8342B-012)
NCT01709318, Phase 2, Completed, Organon and Co; results first posted 2019-12-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings (P06109/MK-8175A/MK-8342B-012). Trials, record NCT01709318. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01709318
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings (P06109/MK-8175A/MK-8342B-012)
- NCT number
- NCT01709318
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 666 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Contraception
- Interventions
- Nomegestrol acetate (NOMAC), Etonogestrel (ENG), Ethinyl estradiol (EE), Estradiol (E2)
- First posted
- 2012-10-18
- Last updated
- 2024-05-28
- Other registries' IDs
- eudract:2012-002459-41
- Results first posted
- 2019-12-05
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Ovulation Incidence, by Cycle | Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days) | 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). |
| Primary | Percentage of Participants With Progesterone Concentrations >16 Nmol/L, by Cycle | Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days) | 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. |
| Primary | Percentage of Participants With Breakthrough Bleeding and/or Spotting During Cycle 3 | Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~28 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. |
| Secondary | Percentage of Participants With Absence of Withdrawal Bleeding and/or Spotting During Cycle 2 | Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 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. |
| Secondary | Intensity of Withdrawal Bleeding During Cycle 2 | Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 days) | 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. |
| Secondary | Intensity of Breakthrough Bleeding and/or Spotting During Cycle 3 | Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~ 28 days) | 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. |
| Secondary | Percentage of Participants Who Experienced At Least One Adverse Event | Up to ~92 days | 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. |
| Secondary | Percentage of Participants Who Experienced At Least One Serious Adverse Event | Up to ~92 days | 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. |
| Secondary | Percentage of Participants Who Experienced At Least One Drug-Related Adverse Event | Up to ~92 days | 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. |
| Secondary | Percentage of Participants With Any Drug-Related Serious Adverse Event | Up to ~92 days | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Ovulation Incidence, by Cycle | Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days) | 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. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Progesterone Concentrations >16 Nmol/L, by Cycle | Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days) | 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. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Breakthrough Bleeding and/or Spotting During Cycle 3 | Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~28 days) | 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. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Absence of Withdrawal Bleeding and/or Spotting During Cycle 2 | Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 days) | 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. | Percentage of Participants | NUMBER |
| SECONDARY | Intensity of Withdrawal Bleeding During Cycle 2 | Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 days) | 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. | Ratio | MEAN |
| SECONDARY | Intensity of Breakthrough Bleeding and/or Spotting During Cycle 3 | Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~ 28 days) | 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. | Ratio | MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Venous or Arterial Thrombotic/Thromboembolic Events | From Cycle 1 Day 1 up to 8 days after Day 28 of Cycle 3 (Up to ~92 days) | The analysis population included all randomized participants in whom a vaginal ring was inserted. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Who Experienced At Least One Adverse Event | Up to ~92 days | The analysis population included all randomized participants in whom a vaginal ring was inserted. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced At Least One Serious Adverse Event | Up to ~92 days | The analysis population included all randomized participants in whom a vaginal ring was inserted. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced At Least One Drug-Related Adverse Event | Up to ~92 days | The analysis population included all randomized participants in whom a vaginal ring was inserted. | Percentage of Participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group112
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Ovulation Incidence, by Cycle | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day | Cycle 1 | 0 | Percentage of Participants | |
| Percentage of Participants With Ovulation Incidence, by Cycle | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day | Cycle 1 | 0 | Percentage of Participants | |
| Percentage of Participants With Ovulation Incidence, by Cycle | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | Cycle 1 | 0 | Percentage of Participants | |
| Percentage of Participants With Ovulation Incidence, by Cycle | Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | Cycle 1 | 0 | Percentage of Participants | |
| Percentage of Participants With Ovulation Incidence, by Cycle | Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | Cycle 1 | 0 | Percentage of Participants | |
| Percentage of Participants With Ovulation Incidence, by Cycle | Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | Cycle 1 | 0 | Percentage of Participants | |
| Percentage of Participants With Ovulation Incidence, by Cycle | NuvaRing® | Cycle 1 | 0 | Percentage of Participants | |
| Percentage of Participants With Ovulation Incidence, by Cycle | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day | Cycle 2 | 0 | Percentage of Participants | |
| Percentage of Participants With Ovulation Incidence, by Cycle | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day | Cycle 2 | 0 | Percentage of Participants | |
| Percentage of Participants With Ovulation Incidence, by Cycle | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | Cycle 2 | 0 | Percentage of Participants |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day | 82 | |
| Overall Study | STARTED | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day | 85 | |
| Overall Study | STARTED | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | 77 | |
| Overall Study | STARTED | Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | 78 | |
| Overall Study | STARTED | Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | 78 | |
| Overall Study | STARTED | Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | 84 | |
| Overall Study | STARTED | NuvaRing® | 182 | |
| Overall Study | Treated | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day | 79 | |
| Overall Study | Treated | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day | 85 | |
| Overall Study | Treated | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | 78 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events70
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day | 2 | 79 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day | 0 | 85 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | 1 | 78 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | 6 | 77 | 9 |
| other | Diarrhoea | Gastrointestinal disorders | Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | 1 | 77 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | 3 | 86 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | NuvaRing® | 2 | 178 | 3 |
| other | Nausea | Gastrointestinal disorders | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day | 4 | 79 | 7 |
| other | Nausea | Gastrointestinal disorders | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day | 1 | 85 | 1 |
| other | Nausea | Gastrointestinal disorders | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | 2 | 78 | 2 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day | 0 | 79 |
| Total, all-cause mortality | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day | 0 | 85 |
| Total, all-cause mortality | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | 0 | 78 |
| Total, all-cause mortality | Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | 0 | 77 |
| Total, all-cause mortality | Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | 0 | 77 |
| Total, all-cause mortality | Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | 0 | 86 |
| Total, all-cause mortality | NuvaRing® | 0 | 178 |
| Total, other adverse events | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day | 23 | 79 |
| Total, other adverse events | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day | 20 | 85 |
| Total, other adverse events | Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | 26 | 78 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30203681 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01709318
GET https://conductscience.org/api/trials/v1/NCT01709318/results?page=2