Trial · NCT01670656

A Study to Evaluate the Effect of Contraceptive Vaginal Rings on Primary Dysmenorrhea (P08257/MK-8175A/MK-8342B-057)

NCT01670656, Phase 2, Completed, Organon and Co; results first posted 2017-08-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate the Effect of Contraceptive Vaginal Rings on Primary Dysmenorrhea (P08257/MK-8175A/MK-8342B-057). Trials, record NCT01670656. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01670656

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Evaluate the Effect of Contraceptive Vaginal Rings on Primary Dysmenorrhea (P08257/MK-8175A/MK-8342B-057)
NCT number: NCT01670656
Status: Completed
Phases: Phase 2
Enrollment: 439 participants, actual
Lead sponsor: Organon and Co
Conditions: Dysmenorrhea
Interventions: Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR), Etonogestrel containing contraceptive vaginal ring (ENG-CVR), Placebo, Ibuprofen
First posted: 2012-08-22
Last updated: 2024-05-28
Other registries' IDs: eudract:2012-002449-40
Results first posted: 2017-08-24

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Mean Menstrual Cramping Pain Score Through Cycle 2	Baseline and Day 29 to 56 (Cycle 2)	The Mean Menstrual Cramping Pain score was calculated as the average of the three highest daily menstrual cramping scores (item #3 of the Menstrual Distress Questionnaire: "Cramps") in the baseline cycle and treatment Cycle 2, respectively. The daily menstrual cramping pain score was based on five pain categories: none (0); mild (1); moderate (2); strong (3); and severe (4). In case of absence of withdrawal bleeding, or onset of menstruation, the mean of the three highest menstrual cramping pain scores recorded within Days 21-28 was used for analysis. The Mean Menstrual Cramping Pain Score in the baseline or subsequent cycles could range from 0 (none) to 4 (severe).
Secondary	Change From Baseline in Total Mean Impact Score Through Cycle 2	Baseline and Day 29 to 56 (Cycle 2)	Total Mean Impact Score is the mean of the sum of the daily responses to questions 6, 8, 9, and 10 in the Dysmenorrhea Daily e-Dairy, as recorded within the menstrual cramping pain analysis window. These questions assessed how much interference there was from pelvic cramping pain on work/school activities (Q6), physical activities (Q8), social/leisure activities (Q9) and sleep (Q10). Each question was rated on a 5-point (0-4) scale, with 0 being "not at all", 1 "slightly", 2 "moderately", 3 "quite a bit" and 4 "extremely". The total mean impact score could thus range from 0 (lowest possible impact) to 16 (highest possible impact).
Secondary	Change From Baseline in Number of Ibuprofen Tablets Taken Through Cycle 2	Baseline and Day 29 to 56 (Cycle 2)	Participants were provided with ibuprofen 400 mg tablets at the screening visit to be taken throughout the study as needed as rescue medication for treating menstrual cramping pain. The maximum daily ibuprofen dose was 3200 mg (8 tablets). Participants were instructed to take the provided ibuprofen, and no other medications, for the relief of menstrual cramping pain, and to record their ibuprofen usage in their e-Diaries.
Secondary	Change From Baseline in Number of Days of Ibuprofen Intake Through Cycle 2	Baseline and Day 29 to 56 (Cycle 2)	Participants were provided with ibuprofen 400 mg tablets at the screening visit to be taken throughout the study as needed as rescue medication for treating menstrual cramping pain. The maximum daily ibuprofen dose was 3200 mg (8 tablets). Participants were instructed to take the provided ibuprofen, and no other medications, for the relief of menstrual cramping pain, and to record their ibuprofen usage in their e-Diaries.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Mean Menstrual Cramping Pain Score Through Cycle 2	Baseline and Day 29 to 56 (Cycle 2)	All randomized participants in whom a vaginal ring was inserted and who had at least one baseline or one post-baseline value for Menstrual Cramping Pain Score	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Total Mean Impact Score Through Cycle 2	Baseline and Day 29 to 56 (Cycle 2)	All randomized participants in whom a vaginal ring was inserted and who had at least one baseline or one post-baseline value for Total Mean Impact Score	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Number of Ibuprofen Tablets Taken Through Cycle 2	Baseline and Day 29 to 56 (Cycle 2)	All randomized participants in whom a vaginal ring was inserted and who had at least one baseline or one post-baseline value for Number of Ibuprofen Tablets Taken	Ibuprofen tablets	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Number of Days of Ibuprofen Intake Through Cycle 2	Baseline and Day 29 to 56 (Cycle 2)	All randomized participants in whom a vaginal ring was inserted and who had at least one baseline or one post-baseline value for Number of Days of Ibuprofen Intake	Days of ibuprofen intake	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Mean Menstrual Cramping Pain Score Through Cycle 2	NOMAC-E2 700/300 mcg	-1.7	95% Confidence Interval -2.0 to -1.5	Units on a scale
Change From Baseline in Mean Menstrual Cramping Pain Score Through Cycle 2	NOMAC-E2 900/300 mcg	-1.7	95% Confidence Interval -1.9 to -1.5	Units on a scale
Change From Baseline in Mean Menstrual Cramping Pain Score Through Cycle 2	ENG-E2 100/300 mcg	-1.9	95% Confidence Interval -2.1 to -1.7	Units on a scale
Change From Baseline in Mean Menstrual Cramping Pain Score Through Cycle 2	ENG-E2 125/300 mcg	-1.7	95% Confidence Interval -1.9 to -1.5	Units on a scale
Change From Baseline in Mean Menstrual Cramping Pain Score Through Cycle 2	Placebo	-1.2	95% Confidence Interval -1.4 to -0.9	Units on a scale
Change From Baseline in Total Mean Impact Score Through Cycle 2	NOMAC-E2 700/300 mcg	-4.8	95% Confidence Interval -5.6 to -4.0	Units on a scale
Change From Baseline in Total Mean Impact Score Through Cycle 2	NOMAC-E2 900/300 mcg	-5.0	95% Confidence Interval -5.7 to -4.2	Units on a scale
Change From Baseline in Total Mean Impact Score Through Cycle 2	ENG-E2 100/300 mcg	-4.7	95% Confidence Interval -5.5 to -3.9	Units on a scale
Change From Baseline in Total Mean Impact Score Through Cycle 2	ENG-E2 125/300 mcg	-4.3	95% Confidence Interval -5.1 to -3.5	Units on a scale
Change From Baseline in Total Mean Impact Score Through Cycle 2	Placebo	-3.1	95% Confidence Interval -3.9 to -2.4	Units on a scale

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow20

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	NOMAC-E2 700/300 mcg	86
Overall Study	STARTED	NOMAC-E2 900/300 mcg	91
Overall Study	STARTED	ENG-E2 100/300 mcg	87
Overall Study	STARTED	ENG-E2 125/300 mcg	85
Overall Study	STARTED	Placebo	90
Overall Study	Treated	NOMAC-E2 700/300 mcg	86
Overall Study	Treated	NOMAC-E2 900/300 mcg	91
Overall Study	Treated	ENG-E2 100/300 mcg	86
Overall Study	Treated	ENG-E2 125/300 mcg	85
Overall Study	Treated	Placebo	90

1 to 10 of 20Source ClinicalTrials.gov

See all 20 participant flow

Adverse events30

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	NOMAC-E2 (700/300 mcg)	9	86	13
other	Headache	Nervous system disorders	NOMAC-E2 (900/300 mcg)	9	91	19
other	Headache	Nervous system disorders	ENG-E2 (100/300 mcg)	11	86	13
other	Headache	Nervous system disorders	ENG-E2 (125/300 mcg)	5	85	7
other	Headache	Nervous system disorders	Placebo	7	90	9
other	Breast pain	Reproductive system and breast disorders	NOMAC-E2 (700/300 mcg)	5	86	7
other	Breast pain	Reproductive system and breast disorders	NOMAC-E2 (900/300 mcg)	1	91	1
other	Breast pain	Reproductive system and breast disorders	ENG-E2 (100/300 mcg)	1	86	1
other	Breast pain	Reproductive system and breast disorders	ENG-E2 (125/300 mcg)	1	85	1
other	Breast pain	Reproductive system and breast disorders	Placebo	2	90	3

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	NOMAC-E2 (700/300 mcg)
Total, all-cause mortality	NOMAC-E2 (900/300 mcg)
Total, all-cause mortality	ENG-E2 (100/300 mcg)
Total, all-cause mortality	ENG-E2 (125/300 mcg)
Total, all-cause mortality	Placebo
Total, other adverse events	NOMAC-E2 (700/300 mcg)	12	86
Total, other adverse events	NOMAC-E2 (900/300 mcg)	11	91
Total, other adverse events	ENG-E2 (100/300 mcg)	14	86
Total, other adverse events	ENG-E2 (125/300 mcg)	7	85
Total, other adverse events	Placebo	11	90

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
30439359	DERIVED

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01670656

GET https://conductscience.org/api/trials/v1/NCT01670656/events?page=2

API reference For AI assistants