NCT01709318

A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings (P06109/MK-8175A/MK-8342B-012)

A Multicenter, Randomized, Partially-blinded, Phase IIb Dose-finding Study on Ovarian Function, Vaginal Bleeding Pattern, and Pharmacokinetics Associated With the Use of Combined Vaginal Rings Releasing 17β-estradiol Plus Three Different Doses of Either Nomegestrol Acetate or Etonogestrel in Healthy Women Aged 18-35 Years. Protocol MK-8175A/MK-8342B 012

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 666 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this trial was to identify at least one next generation ring (NGR) that demonstrates inhibition of ovulation (which was considered confirmed if in the subset of participants ovulation was observed in less than 15% of the participants at any time during the 3 treatment cycles of the study) and cycle control that was non-inferior to NuvaRing®, as judged by the incidence of breakthrough bleeding and/or spotting (BTB-S) during Cycle 3. The primary hypothesis was that at least 1 of the 6 NGRs would show inhibition of ovulation and cycle control during Treatment Cycle 3 that is non-inferior to NuvaRing®, as judged by the incidence of BTB-S.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	Nomegestrol acetate (NOMAC)	Daily release of 500, 700, or 900 μg.
DRUG	Etonogestrel (ENG)	Daily release of 75, 100, 120 or 125 μg
DRUG	Ethinyl estradiol (EE)	Daily release of 15 μg
DRUG	Estradiol (E2)	Daily release of 300 μg

Timeline

• Start date: 2012-12-12
• Primary completion: 2013-10-22
• Completion: 2013-10-22
• First posted: 2012-10-18
• Last updated: 2024-05-28
• Results posted: 2019-12-05