NCT02668783

Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring (MK-8342B) in Women With Primary Dysmenorrhea (With Optional Extension) (MK-8342B-059)

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial to Study the Efficacy and Safety of MK-8342B (ENG-E2 Vaginal Ring) in Women With Moderate to Severe Primary Dysmenorrhea (With Optional Extension)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the etonogestrel (ENG) + 17β-estradiol (E2) vaginal ring's efficacy compared to a placebo vaginal ring in the treatment of dysmenorrhea at Treatment Cycle 2. In addition, this study will assess the safety and tolerability of the ENG-E2 vaginal rings. Primary hypothesis: Relative to the placebo ring, the ENG-E2 vaginal ring results in a greater proportion of participants with a ≥3 point reduction in peak pelvic pain score and no increase in the number of rescue pain relief (ibuprofen) tablets taken at Treatment Cycle 2 as compared to baseline.

Conditions

• Moderate to Severe Primary Dysmenorrhea

Interventions

Type	Name	Description
DRUG	Etonogestrel (ENG) 125 μg + 17β-estradiol (E2) 300 μg vaginal ring	Up to 4 cycles (or 6 cycles if also participating in the extension) of ENG-E2 125 μg/300 μg administered intravaginally. Each cycle will consist of 21 days of vaginal ring use followed by 7 ring-free days.
DRUG	Placebo vaginal ring	Up to 4 cycles (or 6 cycles if also participating in the extension) of placebo administered intravaginally. Each cycle will consist of 21 days of placebo vaginal ring use followed by 7 ring-free days.
DRUG	Ibuprofen	Ibuprofen tablets, to be taken orally, will be provided for use as rescue medication for dysmenorrhea treatment throughout the study. Participants may take 400 mg every 4 hours as needed for pelvic pain/cramping, or as instructed by their physician according to local labeling for relief of menstrual pain.

Timeline

• Start date: 2016-02-11
• Primary completion: 2016-09-07
• Completion: 2016-09-07
• First posted: 2016-01-29
• Last updated: 2024-05-28
• Results posted: 2017-11-14

Regulatory

• FDA-regulated drug study