Dose-finding study of MR-130A-01 contraceptive transdermal patch containing norelgestromi

Phase 1

• Conditions: Investigation of ovulation inhibition for indication of contraception in healthy subjects; MedDRA version: 22.0Level: PTClassification code 10073728Term: Hormonal contraceptionSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2022-003219-26-DE
• Lead Sponsor: Mylan Pharmaceuticals, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-15
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 168

Inclusion Criteria

1. Healthy, post-menarcheal and premenopausal women of age 18 to 35 years (inclusive).
2. BMI =18.0 kg/m2 at screening examination
3. Subjects 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 subject 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 subject during anamnesis, with an intact uterus and ovaries. If the subject 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. Subjects must consent to use reliable non-hormonal contraceptive methods (male condoms, diaphragm, or heterosexual abstinence) throughout the study, unless the subject has a history of female sterilization or sterilization of the sexual partner.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 168
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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 (ß-hCG) pregnancy test at screening
4. Clinically relevant abnormal findings from serum biochemistry and hematology and HBsAg and Hepatitis C virus/human immunodeficiency virus (HIV) serology as evaluated by the investigator
5. ASAT > 20 % ULN, ALAT > 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 intra-uterine 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. Has unexplained vaginal bleeding within the past 6 months suspicious for serious condition, or any abnormal bleeding which is expected to recur during the study (eg. 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. Known dyslipidemias with other known cardiovascular risk factors
11. History or presence of hypertension (including adequately controlled hypertension) or hypertension with vascular disease or elevated 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)
12. Pulse rate < 50 bpm or > 90 bpm
13. Presence of deep vein thrombosis/pulmonary embolism
14. Has any comorbid condition that may require major surgery with prolonged immobilization during the study period
15. History or presence of migraine with aura
16. Presence of liver disease including severe (decompensated) cirrhosis, benign (e.g., hepatocellular adenoma) or malignant liver tumors
17. Chronic disease potentially necessitating organ transplantation during the anticipated course of the study
18. Subjects 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 (WHO 2015, Curtis KM et al., 2016)
• Multiple risk factors for arterial cardiovascular disease (such as older age [35 years at screening or during the study], smoking, diabetes, hypertension and known dyslipidemias)
• History or presence of systemic lupus erythematosus with positive (or unknown) antiphospholipid antibodies
• History (even with no evidence of current disease for 5 years) or presence of or suspected carcinoma of breast
• Has diabetes mellit

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified