NCT01670656

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 439 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The intake of ibuprofen rescue medication and the impact on daily life is investigated: change from baseline data of these two variables will be compared between each of the four active ring groups, separately, and the placebo ring group. Furthermore, the study assesses the measurement characteristics and psychometric properties of a newly developed Dysmenorrhea Daily Dairy. Vaginal bleeding pattern and general safety and tolerability will also be evaluated.

Conditions

• Dysmenorrhea

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2013-01-21
• Primary completion: 2013-09-11
• Completion: 2013-09-12
• First posted: 2012-08-22
• Last updated: 2024-05-28
• Results posted: 2017-08-24