Trial · NCT02616146
Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring and Levonorgestrel-Ethinyl Estradiol Combined Oral Contraceptive in Adult Women at Risk for Pregnancy (MK-8342B-062)
NCT02616146, Phase 3, Terminated, Organon and Co; results first posted 2019-01-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring and Levonorgestrel-Ethinyl Estradiol Combined Oral Contraceptive in Adult Women at Risk for Pregnancy (MK-8342B-062). Trials, record NCT02616146. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02616146
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring and Levonorgestrel-Ethinyl Estradiol Combined Oral Contraceptive in Adult Women at Risk for Pregnancy (MK-8342B-062)
- NCT number
- NCT02616146
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 2,016 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Contraception
- Interventions
- ENG-E2 125 μg/300 μg vaginal ring, LNG-EE 150 μg/30 μg COC
- First posted
- 2015-11-26
- Last updated
- 2024-05-17
- Other registries' IDs
- eudract:2014-002208-26
- Results first posted
- 2019-01-18
- Limitations and caveats
Because the trial was terminated early, participant diary data used for efficacy analysis and bleeding analysis were not verified. These results should be interpreted with caution. No hypothesis testing was performed.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of In-Treatment Pregnancies Per 100 Woman-Years of Exposure in Participants 18-35 Years of Age (Pearl Index) | Up to 1 year (13 28-day cycles) | The Primary Efficacy Outcome Measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure (one woman-year defined as a period of 365.25 days). NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment. |
| Primary | Number of Participants Who Experienced an Adverse Event (AE) | Up to 1 year | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment. |
| Primary | Number of Participants Who Discontinued Treatment Due to an AE | Up to 1 year | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment. |
| Secondary | Number of Participants With Breakthrough Bleeding/Spotting (BTB-S), by Cycle | Up to 1 year | BTB-S was considered any bleeding/spotting that occurred during expected non-bleeding interval that was neither early nor continued withdrawal bleeding. BTB-S was classified as follows: 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. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment. |
| Secondary | Number of Participants With Absence of Withdrawal Bleeding (AWB), by Cycle | Up to 1 year | Participants were asked to keep a daily diary to record vaginal bleeding events. AWB was defined as no bleeding/spotting during the expected bleeding period. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of In-Treatment Pregnancies Per 100 Woman-Years of Exposure in Participants 18-35 Years of Age (Pearl Index) | Up to 1 year (13 28-day cycles) | restricted Full Analysis Set (rFAS) population, defined as the population of women with at least one at risk treatment cycle without documented use of hormonal or nonhormonal backup contraception during the cycle, or participants with a treatment cycle (at risk or not) in which a pregnancy has occurred. | Pregnancies per 100 woman years | NUMBER |
| PRIMARY | Number of Participants Who Experienced an Adverse Event (AE) | Up to 1 year | This primary endpoint was based on all randomized participants in whom at least one vaginal ring was inserted or one comparator tablet was ingested. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Discontinued Treatment Due to an AE | Up to 1 year | This primary endpoint was based on all randomized participants in whom at least one vaginal ring was inserted or one comparator tablet was ingested. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Breakthrough Bleeding/Spotting (BTB-S), by Cycle | Up to 1 year | FAS Evaluable population, defined as a subset of FAS population that met the following criteria: a) No more than 2 consecutive days with missing bleeding data on Daily Diary unless there was at least one day with BTB-S during the ring-use interval; and b) treatment cycle length (including hormone-free interval) is between 22 and 35 days, inclusive. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Absence of Withdrawal Bleeding (AWB), by Cycle | Up to 1 year | FAS Evaluable population, defined as a subset of FAS population that met the following criteria: a) No more than 2 consecutive days with missing bleeding data on Daily Diary unless there was at least one day with BTB-S during the ring-use interval; and b) treatment cycle length (including hormone-free interval) is between 22 and 35 days, inclusive. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of In-Treatment Pregnancies Per 100 Woman-Years of Exposure in Participants 18-35 Years of Age (Pearl Index) | ENG-E2 125 μg/300 μg | 1.54 | Pregnancies per 100 woman years | ||
| Number of In-Treatment Pregnancies Per 100 Woman-Years of Exposure in Participants 18-35 Years of Age (Pearl Index) | LNG-EE 150 μg/30 μg | 2.93 | Pregnancies per 100 woman years | ||
| Number of Participants Who Experienced an Adverse Event (AE) | ENG-E2 125 μg/300 μg | 530 | Participants | ||
| Number of Participants Who Experienced an Adverse Event (AE) | LNG-EE 150 μg/30 μg | 140 | Participants | ||
| Number of Participants Who Discontinued Treatment Due to an AE | ENG-E2 125 μg/300 μg | 61 | Participants | ||
| Number of Participants Who Discontinued Treatment Due to an AE | LNG-EE 150 μg/30 μg | 23 | Participants | ||
| Number of Participants With Breakthrough Bleeding/Spotting (BTB-S), by Cycle | ENG-E2 125 μg/300 μg | Cycle 2 | 166 | Participants | |
| Number of Participants With Breakthrough Bleeding/Spotting (BTB-S), by Cycle | LNG-EE 150 μg/30 μg | Cycle 2 | 54 | Participants | |
| Number of Participants With Breakthrough Bleeding/Spotting (BTB-S), by Cycle | ENG-E2 125 μg/300 μg | Cycle 3 | 112 | Participants | |
| Number of Participants With Breakthrough Bleeding/Spotting (BTB-S), by Cycle | LNG-EE 150 μg/30 μg | Cycle 3 | 36 | Participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ENG-E2 125 μg/300 μg | 1,512 | |
| Overall Study | STARTED | LNG-EE 150 μg/30 μg | 504 | |
| Overall Study | COMPLETED | ENG-E2 125 μg/300 μg | 0 | |
| Overall Study | COMPLETED | LNG-EE 150 μg/30 μg | 0 | |
| Overall Study | NOT COMPLETED | ENG-E2 125 μg/300 μg | 1,512 | |
| Overall Study | NOT COMPLETED | LNG-EE 150 μg/30 μg | 504 |
Source ClinicalTrials.gov
Adverse events26
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 | Headache | Nervous system disorders | ENG-E2 125 μg/300 μg | 116 | 1,504 | 180 |
| other | Headache | Nervous system disorders | LNG-EE 150 μg/30 μg | 40 | 492 | 68 |
| serious | Visual acuity reduced | Eye disorders | ENG-E2 125 μg/300 μg | 0 | 1,504 | 0 |
| serious | Visual acuity reduced | Eye disorders | LNG-EE 150 μg/30 μg | 1 | 492 | 1 |
| serious | Dengue fever | Infections and infestations | ENG-E2 125 μg/300 μg | 1 | 1,504 | 1 |
| serious | Dengue fever | Infections and infestations | LNG-EE 150 μg/30 μg | 0 | 492 | 0 |
| serious | Gastrointestinal infection | Infections and infestations | ENG-E2 125 μg/300 μg | 1 | 1,504 | 1 |
| serious | Gastrointestinal infection | Infections and infestations | LNG-EE 150 μg/30 μg | 0 | 492 | 0 |
| serious | Influenza | Infections and infestations | ENG-E2 125 μg/300 μg | 0 | 1,504 | 0 |
| serious | Influenza | Infections and infestations | LNG-EE 150 μg/30 μg | 1 | 492 | 1 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ENG-E2 125 μg/300 μg | ||
| Total, all-cause mortality | LNG-EE 150 μg/30 μg | ||
| Total, other adverse events | ENG-E2 125 μg/300 μg | 116 | 1,504 |
| Total, other adverse events | LNG-EE 150 μg/30 μg | 40 | 492 |
| Total, serious adverse events | ENG-E2 125 μg/300 μg | 8 | 1,504 |
| Total, serious adverse events | LNG-EE 150 μg/30 μg | 3 | 492 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ENG-E2 125 μg/300 μg vs LNG-EE 150 μg/30 μg: Number of Participants Who Experienced an Adverse Event (AE) | Trial comparisons |
| ENG-E2 125 μg/300 μg vs LNG-EE 150 μg/30 μg: Number of Participants Who Discontinued Treatment Due to an AE | Trial comparisons |
| ENG-E2 125 μg/300 μg vs LNG-EE 150 μg/30 μg: serious adverse events | Trial comparisons |
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/NCT02616146
GET https://conductscience.org/api/trials/v1/NCT02616146/results?page=2