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

Phase 2 Completed 439 enrolled Organon and Co

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

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

Outcome

Met primary endpoint

registry NOMAC-E2 700/300 mcg vs Placebo; p < 0.001; Difference in Least Squares Means -0.6 (95% CI -1.0 to -0.2) NCT01670656 ↗

paper All four investigational rings produced a statistically significantly larger reduction from baseline in mean menstrual pain score compared to placebo while pain medication use decreased. PMID 30439359 ↗

Publications

Fox MC, Klipping C, Nguyen AM, Frenkl TL, Cruz SM, Wang Y, Korver T. A phase 2b multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of vaginal rings containing nomegestrol acetate or etonogestrel and 17beta-estradiol in the treatment of women with primary dysmenorrhea. Contraception. 2019 Feb;99(2):125-130. doi: 10.1016/j.contraception.2018.10.009. Epub 2018 Nov 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Estradiol	Other / unclassified	300 ug	Other
Subject	Etonogestrel	Unknown	100 ug	Other
Subject	Etonogestrel	Unknown	125 ug	Other
Subject	Nomegestrol Acetate	Small molecule	700 ug	Other
Subject	Nomegestrol Acetate	Small molecule	900 ug	Other
Background	Ibuprofen	Small molecule	400 mg	—