NORELGESTROMIN for Hormonal contraception

Inclusion criteria

• {"criterion_text":"- 1. Healthy, post-menarcheal and premenopausal women of age 18 to 35 years (inclusive).\n- 2. BMI ≥18.0 kg/m2 at screening examination.\n- 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.\n- 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.\n- 5. Status at least 3 months after a delivery, abortion, and stopping lactation, if applicable, before screening.\n- 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.\n- 7. Both ovaries must be visible on TVUS examination during screening.\n- 8. Ovulatory pre-treatment cycle, as confirmed by a progesterone concentration >10.0 nmol/L.\n- 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

• {"criterion_text":"- 1. Known hypersensitivity or intolerance to any ingredient of the investigational product.\n- 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\n- 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).\n- 6. Use of a non-hormonal intra-uterine device within the pre-treatment cycle or any hormonal contraception as follows: •\tShort-acting hormonal contraceptives such as oral, patch, ring or intrauterine systems within the menstrual cycle prior to the pre-treatment cycle. •\tInjectable (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.\n- 7. Known or suspected malignancy or history thereof.\n- 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).\n- 9. History or presence of ischemic heart disease, coronary artery disease, myocardial infarction, stroke, other cerebrovascular diseases including transient ischemic attacks (TIAs).\n- 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\n- 17. History or presence of systemic lupus erythematosus with positive (or unknown) antiphospholipid antibodies.\n- 18. History (even with no evidence of current disease) or presence of or suspected carcinoma of breast.\n- 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).\n- 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).\n- 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\n- 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)\n- 22. History or presence of clinically significant depression, as per investigator’s judgment\n- 23. Any condition that, in the opinion of the investigator may jeopardize the participant’s safety or trial conduct according to the protocol.\n- 24. Participation in another clinical trial at same time or within the preceding 30 days (calculated from the date of the last IMP intake).\n- 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.\n- 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.\n- 27. Blood and plasma donation or other blood loss of more than 400 ml or plasmapheresis after signing the informed consent form (ICF).\n- 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.\n- 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.\n- 3. Pulse rate (PR) < 50 bpm or > 90 bpm\n- 30. Participant is in custody or submitted to an institution by a court order of an authority or a court of law.\n- 31. Participants suspected or known not to follow instructions.\n- 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\n- 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.\n- 4. Presence of deep vein thrombosis/pulmonary embolism.\n- 5. Has any comorbid condition that may require major surgery with prolonged immobilization during the study period.\n- 6. Presence of liver disease including severe (decompensated) cirrhosis, benign (e.g., hepatocellular adenoma) or malignant liver tumors.\n- 7. Chronic disease potentially necessitating organ transplantation during the anticipated course of the study.\n- 2. History or presence of dermal sensitivity to medicated patches or to topical applications including bandages, surgical tape.\n- 3. Pregnancy or a positive serum beta human chorionic gonadotropin (β-hCG) pregnancy test at screening."}

Primary endpoints

• {"endpoint_text":"- Ovulation incidence in cycles with regular application, in cycles with 24h application errors & in cycles with 48h application errors. Ovulation is defined as Hoogland-Skouby score 5 or 6 in combination with positive Landgren criterion (i.e., rupture, or development into a luteinized unruptured follicle, of a follicle like structure > 13 mm, with concomitant estradiol [E2] concentrations >100 pmol/L & followed by a luteal phase with progesterone [P] concentrations > 16.0 nmol/L during ≥ 5 days","definition_or_measurement_approach":"Ovulation is defined as Hoogland-Skouby score 5 or 6 in combination with positive Landgren criterion (i.e., rupture, or development into a luteinized unruptured follicle, of a follicle like structure > 13 mm, with concomitant estradiol [E2] concentrations >100 pmol/L & followed by a luteal phase with progesterone [P] concentrations > 16.0 nmol/L during ≥ 5 days). Measurement uses HSS scoring, Landgren criterion assessment (rupture or development into LUFS), follicle-like structure size and serum hormone concentrations."}

Secondary endpoints

• {"endpoint_text":"- •\tOvulation incidence overall •\tOvulation incidence per treatment cycle","definition_or_measurement_approach":"Ovulation incidence measured overall and per treatment cycle (as per primary endpoint definitions using HSS and Landgren criteria)."}
• {"endpoint_text":"- HSS determined for each treatment cycle","definition_or_measurement_approach":"Hoogland-Skouby score (HSS) assessment per treatment cycle."}
• {"endpoint_text":"- Fulfilment of Landgren criterion in cycles with HSS 5 or 6","definition_or_measurement_approach":"Assessment of Landgren criterion (rupture or development into luteinized unruptured follicle) when HSS is 5 or 6."}
• {"endpoint_text":"- FLS diameter and endometrial thickness determined by Transvaginal Ultrasonography (TVUS)","definition_or_measurement_approach":"Transvaginal ultrasonography measurement of follicle like structure (FLS) diameter and endometrial thickness."}
• {"endpoint_text":"- Pituitary (luteinizing hormone [LH]) and ovarian (estradiol [E2], progesterone [P]) hormone concentrations in serum","definition_or_measurement_approach":"Serum assays for LH, estradiol (E2), and progesterone (P) concentrations."}
• {"endpoint_text":"- Plasma concentration of NGMN and its metabolite norgestrel determined: immediately (5min) before and at the end of one scheduled patch-free window (once each per 24/48-hour application-error cycle), and immediately (5min) before application of a new patch (trough, once per regular-application cycle)","definition_or_measurement_approach":"Plasma pharmacokinetic sampling for NGMN and norgestrel at specified timepoints relative to patch-free windows and trough before patch application."}
• {"endpoint_text":"- Plasma concentrations of NGMN and norgestrel","definition_or_measurement_approach":"Plasma concentration measurements (bioanalytical assays) for NGMN and norgestrel."}
• {"endpoint_text":"- Assessment of adhesion score by the participants themselves and by the site personnel","definition_or_measurement_approach":"Participant- and site-assessed patch adhesion scoring."}
• {"endpoint_text":"- Safety and tolerability: treatment-emergent Adverse Events (TEAE); safety clinical laboratory parameters; incidence of application site reactions (skin irritation scores assessed by the participants)","definition_or_measurement_approach":"Safety assessments including TEAEs, laboratory parameters, and participant-assessed skin irritation/application site reaction scores."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Bleeding diary/eDiary assessments recording bleeding and/or spotting episodes and days; analysis of incidence and duration metrics."}

Methods

• K2_Landing page (document present in documents list: 'K2_Landing page_redacted_2025-522565-30-00')
• K2_Flyer (document present in documents list: 'K2_Flyer_redacted_2025-522565-30-00')
• K2_Participant ID card (document present in documents list: 'K2_Participant ID card_redacted_2025-522565-30-00')
• K2_Summary information (document present in documents list: 'K2_Summary information_redacted_2025-522565-30-00')
• K1_Recruitment and Informed consent procedure (document present in documents list: 'K1_Recruitment and Informed consent procedure_redacted_2025-522565-30-00')
• K2_PM Questions and other recruitment arrangements documents (multiple recruitment-related documents listed)

Germany

Earliest CTIS Part Ii Submission Date

31-10-2025

Latest Decision Or Authorization Date

17-11-2025

Processing Time Days

17

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

Mylan Pharmaceuticals Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Third parties

• {"country":"Germany","full_name":"SGS Analytics Germany GmbH","duties_or_roles":"safety laboratory services, laboratory analysis of pharmacodynamic parameters (sponsorDuties entry includes value: 'safety laboratory services, laboratory analysis of pharmacodynamic parameters')","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Germany","full_name":"SocraTec R&D Concepts in Drug Research and Development GmbH","duties_or_roles":"sponsorDuties codes present: 1, 11, 12, 2, 5 (duties listed by code in record; no textual mapping provided)","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Almac Clinical Services Limited","duties_or_roles":"import, repackaging, relabelling, QP release; safety laboratory services / laboratory analysis entries (codes present including code 14 and code 15 with value 'import, repackaging, relabelling, QP release')","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"SocraMetrics GmbH","duties_or_roles":"sponsorDuties codes present: 10, 6 (codes listed; no textual mapping provided)","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"ACC GmbH Analytical Clinical Concepts","duties_or_roles":"bioanalytical analysis (sponsorDuties entry value: 'bioanalytical analysis')","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Mylan Products Limited","duties_or_roles":"pharmacovigilance / safety duties (sponsorDuties code 8; contact email pv.clinical@viatris.com)","organisation_type":"Pharmaceutical company"}