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

NCT06048536 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2024-11-29

No results posted yet for this study

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.

Conditions

  • Contraception

Interventions

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.

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Sandeep Jagtap · Mylan Pharmaceuticals Private Limited (A Viatris Company)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-22
Primary Completion
2024-01-18
Completion
2024-01-18
FDA Drug
Yes

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06048536 on ClinicalTrials.gov