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Investigating Ovulation Inhibition for Use as a Contraceptive | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Investigating Ovulation Inhibition for Use as a Contraceptive

A Single-centre, Open-label, Phase II Study on the Maintenance of Ovulation Inhibition After Intentional Application Contraceptive

NCT07365904•Mylan Pharmaceuticals Inc

View on ClinicalTrials.gov

Summary

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

Detailed Description

Ovulation inhibition study of MR-130A-01 contraceptive transdermal patch containing norelgestromin with intentional application errors; MR-130A-01-TD-2002

Eligibility

Age

18 - 35 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•1\. Healthy, post-menarcheal and premenopausal women of age 18 to 35 years (inclusive) at screening examination.
•2\. BMI ≥18.0 kg/m2 at screening examination. 3. Participants must be in good physical and mental health as determined by vital signs, medical history, and physical and gynecological examination, as assessed by the investigator.
•4\. Written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the participant participating in the clinical trial.
•5\. Status at least 3 months after a delivery, abortion, and stopping lactation, if applicable, before screening.
•6\. Has regular menstrual cycles that are between 21 and 35 days in duration as reported by the participant during anamnesis, with an intact uterus and ovaries. If the participant uses hormonal birth control at screening, historic data should be used to evaluate this criterion.
•7\. Both ovaries must be visible on TVUS examination during screening. 8. Ovulatory pre-treatment cycle, as confirmed by a progesterone concentration \>10.0 nmol/L.
•9\. Participants must consent to use reliable non-hormonal contraceptive methods (male condoms, diaphragm, or heterosexual abstinence) throughout the study, unless the participant has a history of female sterilization or sterilization of the sexual partner.

Exclusion Criteria

•1\. Known hypersensitivity or intolerance to any ingredient of the investigational product.
•2\. History or presence of dermal sensitivity to medicated patches or to topical applications including bandages, surgical tape.
•3\. Pregnancy or a positive serum beta human chorionic gonadotropin (β-hCG) pregnancy test at screening.
•4\. Clinically relevant abnormal findings from serum biochemistry and hematology and HBsAG/ Hepatitis C virus/ human immunodeficiency virus (HIV) serology as evaluated by the investigator 5. ASAT (aspartate-aminotransferase) \> 20 % upper limit of normal (ULN), ALAT (alanine-aminotransferase) \> 10 % ULN, bilirubin \> 20% ULN (except in case of existing Morbus Gilbert-Meulengracht deduced from anamnesis/medical history) and creatinine \> 0.1 mg/dL ULN (limit of \> 0.1 mg/dL corresponds to \> 9 µmol/l ULN).
•6\. Use of a non-hormonal intra-uterine device within the pre-treatment cycle or any hormonal contraception as follows:
•* 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.
•7\. Known or suspected malignancy or history thereof. 8. Unexplained vaginal bleeding within the past 6 months suspicious for serious condition, or any abnormal bleeding which is expected to recur during the study (e.g. bleeding from cervical polyp, recurrent bleeding after sex).
•9\. History or presence of ischemic heart disease, coronary artery disease, myocardial infarction, stroke, other cerebrovascular diseases including transient ischemic attacks (TIAs).
•10\. History or presence of hypertension or hypertension with vascular disease or elevated blood pressure (BP) defined as systolic BP ≥140 mm Hg or diastolic BP ≥90 mm Hg, measured in sitting position after at least 5 minutes of rest (a single reading of blood pressure level is not sufficient to classify a woman as hypertensive).
+3 more criteria

Locations (1)

dinox GmbH

Berlin, Germany

Key Dates

Start Date

December 22, 2025

Primary Completion Date

November 30, 2026

Completion Date

November 30, 2026

Last Updated

January 26, 2026

Enrollment

ESTIMATED participants

Conditions

Contraception

Interventions

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

DRUG

Contacts

Erin R Larnerd

CONTACT

3045545844 erin.larnerd@viatris.com

Laura F Zachwieja

CONTACT

304-680-0256 laura.zachwieja@viatris.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 26, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Investigating Ovulation Inhibition for Use as a Contraceptive

Inclusion Criteria

Exclusion Criteria

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