NCT06048536

Dose-finding Study of MR-130A-01 Contraceptive Transdermal Patch

An Open-label, Phase II, Dose-finding Study of Three Dose Strengths of MR-130A-01 Contraceptive Transdermal Patch in Healthy Pre-menopausal Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

A single-center, randomized, open-label, parallel-group, multi-arm, phase II clinical trial in healthy women aged 18 to 35 years who have a documented ovulatory cycle prior to randomization.

Detailed description

MR-130A-01 is a progestin-only TDS containing NGMN as its progestin. NGMN is currently available in combination with EE in CHC TDSs Xulane® (US) and Evra® (EU), at doses of 150 mcg/day (Xulane® USPI 2022) and 203 mcg/day (Evra®SmPC 2022) respectively. In the currently planned dose-finding clinical trial the ovulation inhibition and the impact on further physiological functions and hormones of the three dose strengths of MR-130A-01 will be investigated in healthy pre-menopausal obese and non-obese women with ovulatory menstrual cycles. Eligible subjects will be randomized according to their body mass index (BMI) into one of 7 treatment arms with different doses and regimens of IMP administration. The IMPs which are transdermal patches, will be applied to the skin (upper outer arm, abdomen, buttock or back) and will be changed weekly. Depending on the treatment arm, either 4 or 3 patches of an allocated patch strength will be applied per cycle (28/0-day regimen and 21/7-day regimen). Patch adhesion will be assessed by the subjects daily and the results (adhesion scores) will be recorded in a diary. Throughout the clinical trial, ovarian activity will be monitored by TVUS, and blood samples will be collected for determination of progesterone (P), estradiol (E2), LH and FSH concentrations. The inhibition of ovulation will be assessed by Hoogland and Skouby Score (HSS). In addition, bleeding pattern will be assessed based on the subject's records of bleeding and its intensity in a diary.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	MR-130A-01 Transdermal patch	MR-130A-01 transdermal patch, containing 2.43 mg Norelgestromin, will be worn 28 days per cycle with no patch free period.
DRUG	MR-130A-01 Transdermal patch	MR-130A-01 transdermal patch, containing 3.64 mg Norelgestromin, will be worn 28 days per cycle with no patch free period.
DRUG	MR-130A-01 Transdermal patch	MR-130A-01 transdermal patch containing 4.86 mg Norelgestromin, will be worn 28 days per cycle with no patch free period
DRUG	MR-130A-01 Transdermal patch	MR-130A-01 Transdermal patch MR-130A-01 transdermal patch containing 4.86 mg Norelgestromin, will be worn 21 days with a 7-day patch free period.

Timeline

• Start date: 2023-12-22
• Primary completion: 2024-01-18
• Completion: 2024-01-18
• First posted: 2023-09-21
• Last updated: 2024-11-29

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study