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New treatment option for Contraception
Official title Investigating Ovulation Inhibition for Use as a Contraceptive
ClinicalTrials.gov ID: NCT07365904
What this study is testing
What is MR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN)?
MR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN) is an investigational medicine, being studied as a potential treatment for contraception.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 35, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 4\. Written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the...
- 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...
You likely can't join if
- 1\. Known hypersensitivity or intolerance to any ingredient of the investigational product. 2\. History or presence of dermal sensitivity to...
- 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...
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, Germany
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years to 35 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.