At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Partially Blinded, Placebo-controlled Clinical Trial to Evaluate the Effect on Primary Dysmenorrhea of Vaginal Rings With an Average Daily Release of 700 μg Nomegestrol Acetate (NOMAC) and 300 μg Estradiol (E2), or 900 μg Nomegestrol Acetate (NOMAC) and 300 μg Estradiol (E2), or 100 μg Etonogestrel (ENG) and 300 μg E2, or 125 μg Etonogestrel (ENG) and 300 μg E2. Protocol MK-8175A/MK-8342B 057 (Abbreviated as P057), Also Known as SCH900121/SCH900432 08257 (Abbreviated as P08257)
In Brief
A Phase 2 clinical trial evaluating Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR), Etonogestrel containing contraceptive vaginal ring (ENG-CVR), and 2 other interventions for Dysmenorrhea. Completed, enrolled 439 participants.
Detailed 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.
Study Details
Timeline
Interventions
Either 700 or 900 mcg NOMAC and 300 mcg E2 intravaginal ring for two 28-day cycles
Either 100 or 125 mcg ENG and 300 mcg E2, intravaginally for two 28-day cycles
Placebo to match vaginal ring, intravaginally for two 28-day cycles
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)