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

NCT01670656 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 439

Last updated 2024-05-28

Study results available
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Summary

The study investigates four vaginal ring groups with respect to relief of primary dysmenorrhea, and should identify at least one vaginal ring that shows clinically relevant treatment efficacy in relief of primary dysmenorrhea.

Conditions

  • Dysmenorrhea

Interventions

DRUG

Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR)

Either 700 or 900 mcg NOMAC and 300 mcg E2 intravaginal ring for two 28-day cycles

DRUG

Etonogestrel containing contraceptive vaginal ring (ENG-CVR)

Either 100 or 125 mcg ENG and 300 mcg E2, intravaginally for two 28-day cycles

DRUG

Placebo

Placebo to match vaginal ring, intravaginally for two 28-day cycles

DRUG

Ibuprofen

Ibuprofen 400 mg will be dispensed throughout the entire study as needed as rescue medication for treating menstrual cramping pain. The maximum daily ibuprofen dose is 3200 mg (8 tablets)

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-21
Primary Completion
2013-09-11
Completion
2013-09-12

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01670656 on ClinicalTrials.gov