Authorised Therapeutic exploratory (Phase II) Investigation of maintenance of ovulation inhibition after intentional application errors for indication of contraception in healthy subjects

A study on the maintenance of ovulation inhibition after intentional application errors during 84 days of treatment with a contraceptive transdermal patch

EU CTIS ID: 2025-522565-30-00

What this study is testing

To investigate if ovulation inhibition with MR-130A-01 is maintained despite intentional 24-hour and 48-hour application errors

Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Healthy, post-menarcheal and premenopausal women of age 18 to 35 years (inclusive).
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 gynaecological 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 participants 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.

You likely can't join if

1. Known hypersensitivity or intolerance to any ingredient of the investigational product.
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).

See the full eligibility criteria

Who can join

1. Healthy, post-menarcheal and premenopausal women of age 18 to 35 years (inclusive).
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 gynaecological 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 participants 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.

What rules you out

1. Known hypersensitivity or intolerance to any ingredient of the investigational product.
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).
16. Participants having any other known contraindication to progestin-only contraception as defined by category 3 or 4 conditions per World Health Organization Medical eligibility criteria for contraceptive use, 2015 or Centers for Disease Control and Prevention (CDC) US Medical Eligibility Criteria (US MEC) for Contraceptive Use, 2016
17. History or presence of systemic lupus erythematosus with positive (or unknown) antiphospholipid antibodies.
18. History (even with no evidence of current disease) or presence of or suspected carcinoma of breast.
19. Participant has requirement to be on treatment with medications prohibited during the study (phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine) or rifampin or rifabutin therapy, see Chapter 13.2.1 for additional information on prohibited medications).
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).
20. Presence or history of acute or chronic diseases especially of the skin, which could affect dermal absorption or metabolism, which may interfere with the bioavailability and/or the pharmacokinetics of the Investigational Medicinal Product (IMP) based on assessment of the investigator
21. Skin abnormality (e.g., tattoo or scar) at all possible application sites (at least two different applications sites with normal skin situation are required)
22. History or presence of clinically significant depression, as per investigator’s judgment
23. Any condition that, in the opinion of the investigator may jeopardize the participant’s safety or trial conduct according to the protocol.
24. Participation in another clinical trial at same time or within the preceding 30 days (calculated from the date of the last IMP intake).
25. Recent history (within prior 12 months) of drug or alcohol abuse or at the Investigator’s discretion, history greater than 12 months prior and at risk for noncompliance.
26. Abnormal cervical smear (Pap ≥ 3 acc. to Munich III nomenclature) at screening examination, or history of documented abnormal cervical smear (Pap ≥ 3) within one year of screening.
27. Blood and plasma donation or other blood loss of more than 400 ml or plasmapheresis after signing the informed consent form (ICF).
28. In case of preceding washout phase from hormonal contraception (see Chapter 13.2.1 of the Clinical Trial Protocol), no spontaneous menses within 46 days after stop of short-acting hormonal contraceptive.
29. Close affiliation with the sponsor or the investigational site; e.g., a close relative of the investigator, dependent person (e.g., employee of or student at the investigational site), employee of the sponsor or affiliates.
11. Pulse rate (PR) < 50 bpm or > 90 bpm
30. Participant is in custody or submitted to an institution by a court order of an authority or a court of law.
31. Participants suspected or known not to follow instructions.
32. Participants who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial
33. Criteria, which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the participant’s safety.
12. Presence of deep vein thrombosis/pulmonary embolism.
13. Has any comorbid condition that may require major surgery with prolonged immobilization during the study period.
14. Presence of liver disease including severe (decompensated) cirrhosis, benign (e.g., hepatocellular adenoma) or malignant liver tumors.
15. Chronic disease potentially necessitating organ transplantation during the anticipated course of the study.
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.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.