NCT02668822

Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring (MK-8342B) in the Treatment of Women With Primary Dysmenorrhea (MK-8342B-060)

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the efficacy of the etonogestrel (ENG) + 17β-estradiol (E2) (MK-8342B) vaginal ring compared to placebo vaginal ring in the treatment of dysmenorrhea at Treatment Cycle 2. This study was also to assess the safety and tolerability of the ENG-E2 vaginal rings over 4 treatment cycles. 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.

Detailed description

The cramping window for each participant was to be defined as a 4-day time interval that began the day prior to initiation of each cyclic bleeding episode (spontaneous menses or hormone withdrawal bleeding) and continued until the third bleeding day (inclusive). An external committee of blinded independent reviewers was to determine the 4-day cramping window for each participant so that analysis of the efficacy data could be conducted. The study was terminated early due to a business decision by the Sponsor to discontinue product development for reasons unrelated to safety or efficacy outcomes. Due to the early study termination, the blinded independent review committee that was supposed to determine the 4-day cramping windows for data analysis was not assembled; thus cramping windows were not determined. Without defined cramping windows, the efficacy outcome measures for this study could not be analyzed.

Conditions

• Dysmenorrhea

Interventions

Type	Name	Description
DRUG	ENG 125 μg + E2 300 μg vaginal ring (MK-8342B)	Medicated vaginal ring
DRUG	Placebo vaginal ring	Placebo vaginal ring
DRUG	Ibuprofen	Ibuprofen 400-mg tablets, to be taken orally, were provided to the participants for use as rescue medication for dysmenorrhea treatment throughout the study. Participants may have taken 400 mg every 4 hours as needed for pelvic pain/cramping.

Timeline

• Start date: 2016-02-09
• Primary completion: 2016-09-12
• Completion: 2016-09-12
• First posted: 2016-01-29
• Last updated: 2024-05-28
• Results posted: 2017-11-08

Regulatory

• FDA-regulated drug study