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

Dysmenorrhea Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Dysmenorrhea

• NCT number: NCT01670656
• Study type: Interventional
• Source: Organon and Co
• Status: Completed
• Phase: Phase 2
• Start date: January 21, 2013
• Completion date: September 12, 2013