Investigating Ovulation Inhibition for Use as a Contraceptive (NCT07365904) | Clinical Trial Compass
RecruitingPhase 2
Investigating Ovulation Inhibition for Use as a Contraceptive
Germany60 participantsStarted 2025-12-22
Plain-language 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
Who can participate
Age range18 Years – 35 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ingre…
What they're measuring
1
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.