Investigating Ovulation Inhibition for Use as a Contraceptive

Sponsor
Mylan Pharmaceuticals Inc
Study ID
NCT07365904
Phase
PHASE2
Status
Recruiting
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Conditions

  • Contraception

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 35 Years
Healthy Volunteers
Accepted

Interventions

  • MR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN) — DRUG
    MR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN)

Study Details

A single-centre, open-label, randomised, phase II study on the maintenance of ovulation inhibition after intentional application errors during 84 days of treatment with MR 130A 01 contraceptive transdermal patch

Key Dates

First listed
Jan 26, 2026
Start date
Dec 22, 2025
Status verified
Jan 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: "regular": regular application without planned application errors
  • Experimental: Extended Period 1: regular application with planned application errors
  • Experimental: Extended Period 2: regular application with planned application errors

Primary Outcome Measure

Ovulation incidence in cycle with regular application, and in cycles with extended period application errors. Ovulation is defined as a Hoogland-Skouby score 5 or 6 in combination with fulfilment of Landgren criterion. [ Time Frame: 84 days ]

Central Contacts

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