Investigating Ovulation Inhibition for Use as a Contraceptive
ConditionContraception
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorMylan Pharmaceuticals Inc
About this trial
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
Eligibility criteria
Qualifiers
1. Healthy, post-menarcheal and premenopausal women of age 18 to 35 years (inclusive) at screening examination.
Disqualifiers
1. Known hypersensitivity or intolerance to any ingredient of the investigational product.
Short-acting hormonal contraceptives such as oral, patch, ring or intrauterine systems within the menstrual cycle prior to the pre-treatment cycle.
Injectable (intramuscularly or subcutaneously) within 10 months (three-month treatment duration), 6 months (two-month treatment duration) or 3 months (one-month treatment duration) prior to the start of pre-treatment cycle or implants within the menstrual cycle prior to the pre-treatment cycle.
Trial design
Treatments tested in this trial
- MR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN)
Treatment groups
60 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov