Actively Recruiting
Investigating Ovulation Inhibition for Use as a Contraceptive
Led by Mylan Pharmaceuticals Inc · Updated on 2026-01-26
60
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Investigating Ovulation Inhibition for Use as a Contraceptive
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy, post-menarcheal and premenopausal women aged 18 to 35 years (inclusive) at screening
- Body mass index (BMI) of at least 18.0 kg/m2 at screening
- Good physical and mental health as assessed by vital signs, medical history, and physical and gynecological exam
- Written informed consent after being informed about trial benefits, risks, and insurance
- At least 3 months since delivery, abortion, or stopping lactation if applicable
- Regular menstrual cycles between 21 and 35 days with intact uterus and ovaries
- Both ovaries must be visible on transvaginal ultrasound during screening
- Ovulatory pre-treatment cycle confirmed by progesterone concentration above 10.0 nmol/L
- Consent to use reliable non-hormonal contraceptive methods throughout the study unless sterilized or partner sterilized
You will not qualify if you...
- Known allergy or intolerance to any ingredient of the investigational patch
- History or presence of skin sensitivity to medicated patches, topical applications, bandages, or surgical tape
- Pregnancy or positive pregnancy test at screening
- Abnormal serum biochemistry, hematology, or positive tests for hepatitis B, hepatitis C, or HIV
- Elevated liver enzymes or creatinine above specified limits, except for known Gilbert-Meulengracht syndrome
- Use of non-hormonal intra-uterine device during pre-treatment cycle or hormonal contraception within specified recent periods
- Known or suspected cancer or history of malignancy
- Unexplained vaginal bleeding within 6 months or bleeding expected to recur during study
- History or presence of ischemic heart disease, stroke, or cerebrovascular diseases including TIAs
- History or presence of hypertension or elevated blood pressure (systolic ≥140 mm Hg or diastolic ≥90 mm Hg)
- Pulse rate below 50 bpm or above 90 bpm
- Presence of deep vein thrombosis or pulmonary embolism
- Comorbid conditions requiring major surgery with prolonged immobilization during study
- Presence of liver disease including severe cirrhosis or liver tumors
- Chronic disease potentially requiring organ transplantation during study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
dinox GmbH
Berlin, Germany
Actively Recruiting
Research Team
E
Erin R Larnerd
CONTACT
L
Laura F Zachwieja
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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