ContraceptionPhase 2NCT07365904
Investigating Ovulation Inhibition for Use as a Contraceptive
A Phase 2 study testing MR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN) in people with Contraception, run by Mylan Pharmaceuticals Inc at 1 site in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- MR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 22 Dec 2025to 30 Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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).
- 11. Pulse rate (PR) < 50 bpm or > 90 bpm 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
dinox GmbH
Berlin
Corrina Draeger, +49-30-440595-22, corrina.draeger@dinox.de
About this study
Official title: A Single-centre, Open-label, Phase II Study on the Maintenance of Ovulation Inhibition After Intentional Application Contraceptive
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
Read the detailed description
Ovulation inhibition study of MR-130A-01 contraceptive transdermal patch containing norelgestromin with intentional application errors; MR-130A-01-TD-2002
- Conditions
- Contraception
- Being tested
- MR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN)Drug
MR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN)
| Study group | Role | What they receive |
|---|---|---|
| "regular": regular application without planned application errors | Experimental | Not described Receives: Drug: MR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN) |
| Extended Period 1: regular application with planned application errors | Experimental | Not described Receives: Drug: MR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN) |
| Extended Period 2: regular application with planned application errors | Experimental | Not described Receives: Drug: MR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 84 days
Secondary outcomes (10)
Ovulation incidence overall and incidence per treatment cycle.
Measured: 84 days
HSS determined for each treatment cycle.
Measured: 84 days
Fulfilment of Landgren criterion in cycles with HSS 5 or 6.
Measured: 84 days
FLS diameter and endometrial thickness determined by transvaginal ultrasound (TVUS).
Measured: 84 days
Pituitary (luteinizing hormone [LH]) and ovarian (estradiol [E2], progesterone [P]) hormone concentrations in serum.
Measured: 84 days
Plasma concentration of NGMN and its metabolite norgestrel Immediately 5min before and at the end of one scheduled patch-free window.
Measured: 84 days
Plasma concentrations of NGMN and norgestrel.
Measured: 84 days
Assessment of adhesion score by the participants themselves and by the site personnel.
Measured: 84 days
Safety and tolerability: Treatment-emergent Adverse Events (TEAE) Safety clinical laboratory parameters Incidence of application site reactions (skin irritation scores assessed by the participants).
Measured: 84 days
Bleeding pattern determined as Incidences of bleeding and/or spotting episodes. Number of observed days of bleeding and/or spotting, bleeding only and spotting only. Incidences of complete absence of bleeding or spotting (excluding the first episode).
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start22 Dec 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mylan Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandeep Jagtap, Study director, Meda Pharma GmbH & Co. KG (a Viatris company)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365904
- Sponsor's protocol ID
- MR-130A-01-TD-2002
- Status last verified
- Jan 2026
- First submitted
- 8 Sep 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Open-label, Phase II Study on the Maintenance of Ovulation Inhibition After Intentional Application Contraceptive
- ClinicalTrials.gov ID
- NCT07365904
- Acronym / sponsor ID
- MR-130A-01-TD-2002
- Conditions
- Contraception
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mylan Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| "regular": regular application without planned application errors | Experimental | Drug: MR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN) |
| Extended Period 1: regular application with planned application errors | Experimental | Drug: MR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN) |
| Extended Period 2: regular application with planned application errors | Experimental | Drug: MR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN)MR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN) | Drug | "regular": regular application without planned application errors, Extended Period 1: regular application with planned application errors, Extended Period 2: regular application with planned application errors |
Primary outcome
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.
Time frame: 84 days
10 secondary outcomes
Ovulation incidence overall and incidence per treatment cycle.
Time frame: 84 days
HSS determined for each treatment cycle.
Time frame: 84 days
Fulfilment of Landgren criterion in cycles with HSS 5 or 6.
Time frame: 84 days
FLS diameter and endometrial thickness determined by transvaginal ultrasound (TVUS).
Time frame: 84 days
Pituitary (luteinizing hormone [LH]) and ovarian (estradiol [E2], progesterone [P]) hormone concentrations in serum.
Time frame: 84 days
Plasma concentration of NGMN and its metabolite norgestrel Immediately 5min before and at the end of one scheduled patch-free window.
Time frame: 84 days
Plasma concentrations of NGMN and norgestrel.
Time frame: 84 days
Assessment of adhesion score by the participants themselves and by the site personnel.
Time frame: 84 days
Safety and tolerability: Treatment-emergent Adverse Events (TEAE) Safety clinical laboratory parameters Incidence of application site reactions (skin irritation scores assessed by the participants).
Time frame: 84 days
Bleeding pattern determined as Incidences of bleeding and/or spotting episodes. Number of observed days of bleeding and/or spotting, bleeding only and spotting only. Incidences of complete absence of bleeding or spotting (excluding the first episode).
Time frame: 84 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sandeep Jagtap study director
Meda Pharma GmbH & Co. KG (a Viatris company)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN) in people with Contraception, run by Mylan Pharmaceuticals Inc at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin R Larnerd (3045545844, erin.larnerd@viatris.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.