Trial · NCT02668783
Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring (MK-8342B) in Women With Primary Dysmenorrhea (With Optional Extension) (MK-8342B-059)
NCT02668783, Phase 3, Terminated, Organon and Co; results first posted 2017-11-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring (MK-8342B) in Women With Primary Dysmenorrhea (With Optional Extension) (MK-8342B-059). Trials, record NCT02668783. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02668783
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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 (MK-8342B) in Women With Primary Dysmenorrhea (With Optional Extension) (MK-8342B-059)
- NCT number
- NCT02668783
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 25 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Moderate to Severe Primary Dysmenorrhea
- Interventions
- Etonogestrel (ENG) 125 μg + 17β-estradiol (E2) 300 μg vaginal ring, Placebo vaginal ring, Ibuprofen
- First posted
- 2016-01-29
- Last updated
- 2024-05-28
- Other registries' IDs
- eudract:2015-004325-14
- Results first posted
- 2017-11-14
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With ≥3 Point Reduction in Peak Pelvic Pain Score and no Increase in Number of Ibuprofen Tablets Taken at Treatment Cycle 2, Compared to Baseline. | Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant | Participants were asked to rate their worst pain or cramps in the past 24 hours on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps) and to indicate the number of ibuprofen tablets they took during the 4-day cramping window. The peak pelvic pain score was to be calculated as the highest (daily) pelvic pain score observed within the cramping window of the cycle and the total number of ibuprofen tablets taken was to be based on the 4-day cramping window. The baseline peak pelvic pain score and number of ibuprofen tablets taken were to be defined as the mean value of the 2 peak pelvic pain scores and the mean value of the total number of ibuprofen tablets taken during the cramping window of each of the 2 menstruations during the screening period, respectively. The percentage of participants with a reduction in peak pelvic pain score of ≥3 points and no increase in the use of ibuprofen at Treatment Cycle 2 as compared to baseline was to be presented. |
| Primary | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 158 days | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who experienced an AE is presented. |
| Primary | Number of Participants Who Discontinued Treatment Due to an AE | Up to approximately 128 days | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who discontinued study treatment due to an AE is presented. |
| Secondary | Change From Baseline in Peak Pelvic Pain Score at Treatment Cycle 2 | Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant | Participants were asked to rate their worst pain or cramps in the past 24 hours on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps). The peak pelvic pain score was to be calculated as the highest (daily) pelvic pain score observed within the 4-day cramping window of the cycle. The baseline peak pelvic pain score was to be defined as the mean value of the 2 peak pelvic pain scores during the cramping window of each of the 2 menstruations during the screening period. The change from baseline in peak pelvic pain score at Treatment Cycle 2 was to be presented. |
| Secondary | Change From Baseline in the Number of Days With no Impact on Items of Physical, Work/School and Social/Leisure Activities at Treatment Cycle 2 | Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant | Participants were asked to indicate how much pain or cramps limited their physical, work/school and social/leisure activities and over the previous 24 hours. The level of negative impact of dysmenorrhea on daily life was scored on a 5-point scale (0=Not at all to 4=Extremely impacted). For each of the 3 impact items, the baseline score was to be defined as the mean value obtained from the 2 menstruations during the screening period. The change from baseline to Treatment Cycle 2 in the number of days during the cramping window with no impact of dysmenorrhea (score = 0) on each of the following items was to be presented: work/school, physical activities and leisure/social activities. |
| Secondary | Percentage of Participants With Pelvic Pain Score of "0" or "1" and no Use of Ibuprofen Tablets at Treatment Cycle 2 | Treatment Cycle 2 4-day cramping window, as determined by committee for each participant | Participants were asked to rate their worst pain or cramps on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps) and to indicate the number of ibuprofen tablets they took during the 4-day cramping window. The percentage of participants with no or minimal pelvic pain (score of "0" or "1") and no use of ibuprofen at Treatment Cycle 2 was to be presented. |
| Secondary | Percentage of Participants With ≥3 Point Reduction in Peak Pelvic Pain Score and a Decrease in Ibuprofen Tablet Intake at Treatment Cycle 2, Compared to Baseline | Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant | Participants were asked to rate their worst pain or cramps in the past 24 hours on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps) and to indicate the number of ibuprofen tablets they took during the 4-day cramping window. The baseline peak pelvic pain score and number of ibuprofen tablets taken were to be defined as the mean value of the 2 peak pelvic pain scores and the mean value of the total number of ibuprofen tablets taken during the cramping window of each of the 2 menstruations during the screening period, respectively. The percentage of participants with a reduction in peak pelvic pain score of ≥3 points and a decrease in the use of ibuprofen at Treatment Cycle 2 as compared to baseline was to be presented. |
| Secondary | Change From Baseline in Mean Pelvic Pain Score at Treatment Cycle 2 | Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant | The mean pelvic pain score was to be calculated as the mean of the highest scores for pelvic pain observed within the 4-day cramping window of the screening or treatment cycle. The baseline mean pelvic pain score was to be defined as the mean value of the 2 mean pelvic pain scores of the 2 menstruations during the screening period. The change from baseline in mean pelvic pain score at Treatment Cycle 2 was to be presented. |
Source ClinicalTrials.gov
Outcomes8
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 ≥3 Point Reduction in Peak Pelvic Pain Score and no Increase in Number of Ibuprofen Tablets Taken at Treatment Cycle 2, Compared to Baseline. | Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant | Population was to consist of all participants in whom vaginal ring was inserted \& who had ≥1 day of diary entry each within a 4-day cramping window during a baseline cycle \& a treatment cycle. Due to termination, committee to determine cramping windows was not assembled, cramping windows were not determined \& efficacy data could not be analyzed. | ||
| PRIMARY | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 158 days | All randomized participants in whom a vaginal ring was inserted. | Participants | NUMBER |
| PRIMARY | Number of Participants Who Discontinued Treatment Due to an AE | Up to approximately 128 days | All randomized participants in whom a vaginal ring was inserted. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Peak Pelvic Pain Score at Treatment Cycle 2 | Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant | Population was to consist of all participants in whom a vaginal ring was inserted \& who had ≥1 day of diary entry each within 4-day cramping window during a baseline cycle \& a treatment cycle. Due to termination, committee to determine cramping windows was not assembled, cramping windows were not determined \& efficacy data could not be analyzed. | ||
| SECONDARY | Change From Baseline in the Number of Days With no Impact on Items of Physical, Work/School and Social/Leisure Activities at Treatment Cycle 2 | Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant | Population was to consist of all participants in whom a vaginal ring was inserted \& who had ≥1 day of diary entry each within a 4-day cramping window during a baseline cycle \& a treatment cycle. Due to termination, committee to determine cramping windows was not assembled, cramping windows were not determined \& efficacy data could not be analyzed. | ||
| SECONDARY | Percentage of Participants With Pelvic Pain Score of 0 or 1 and no Use of Ibuprofen Tablets at Treatment Cycle 2 | Treatment Cycle 2 4-day cramping window, as determined by committee for each participant | Population was to consist of all participants in whom a vaginal ring was inserted \& who had ≥1 day of diary entry each within a 4-day cramping window during Treatment Cycle 2. Due to termination, committee to determine cramping windows was not assembled, cramping windows were not determined \& efficacy data could not be analyzed. | ||
| SECONDARY | Percentage of Participants With ≥3 Point Reduction in Peak Pelvic Pain Score and a Decrease in Ibuprofen Tablet Intake at Treatment Cycle 2, Compared to Baseline | Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant | Population was to consist of all participants in whom a vaginal ring was inserted \& who had ≥1 day of diary entry each within a 4-day cramping window during a baseline cycle \& a treatment cycle. Due to termination, committee to determine cramping windows was not assembled, cramping windows were not determined \& efficacy data could not be analyzed. | ||
| SECONDARY | Change From Baseline in Mean Pelvic Pain Score at Treatment Cycle 2 | Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant | Population was to consist of all participants in whom a vaginal ring was inserted \& who had ≥1 day of diary entry each within a 4-day cramping window during a baseline cycle \& a treatment cycle. Due to termination, committee to determine cramping windows was not assembled, cramping windows were not determined \& efficacy data could not be analyzed. |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experienced an Adverse Event (AE) | ENG-E2 125 μg/300 μg | 1 | Participants | ||
| Number of Participants Who Experienced an Adverse Event (AE) | Placebo | 2 | Participants | ||
| Number of Participants Who Discontinued Treatment Due to an AE | ENG-E2 125 μg/300 μg | 0 | Participants | ||
| Number of Participants Who Discontinued Treatment Due to an AE | Placebo | 0 | Participants |
Source ClinicalTrials.gov
Participant flow8
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 | 13 | |
| Overall Study | STARTED | Placebo | 12 | |
| Overall Study | Treated | ENG-E2 125 μg/300 μg | 13 | |
| Overall Study | Treated | Placebo | 11 | |
| Overall Study | COMPLETED | ENG-E2 125 μg/300 μg | 0 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | ENG-E2 125 μg/300 μg | 13 | |
| Overall Study | NOT COMPLETED | Placebo | 12 |
Source ClinicalTrials.gov
Adverse events6
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 | Vomiting in pregnancy | Pregnancy, puerperium and perinatal conditions | ENG-E2 125 Microgram/300 Microgram | 0 | 13 | 0 |
| other | Vomiting in pregnancy | Pregnancy, puerperium and perinatal conditions | Placebo | 1 | 11 | 1 |
| other | Mood swings | Psychiatric disorders | ENG-E2 125 Microgram/300 Microgram | 1 | 13 | 1 |
| other | Mood swings | Psychiatric disorders | Placebo | 0 | 11 | 0 |
| other | Vulvovaginal discomfort | Reproductive system and breast disorders | ENG-E2 125 Microgram/300 Microgram | 0 | 13 | 0 |
| other | Vulvovaginal discomfort | Reproductive system and breast disorders | Placebo | 1 | 11 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ENG-E2 125 Microgram/300 Microgram | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | ENG-E2 125 Microgram/300 Microgram | 1 | 13 |
| Total, other adverse events | Placebo | 2 | 11 |
| Total, serious adverse events | ENG-E2 125 Microgram/300 Microgram | 0 | 13 |
| Total, serious adverse events | Placebo | 0 | 11 |
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 Placebo: Number of Participants Who Experienced an Adverse Event (AE) | Trial comparisons |
| ENG-E2 125 μg/300 μg vs Placebo: Number of Participants Who Discontinued Treatment Due to an AE | Trial comparisons |
| ENG-E2 125 Microgram/300 Microgram vs Placebo: 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/NCT02668783
GET https://conductscience.org/api/trials/v1/NCT02668783/registered