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system containing progestin

Phase 3

Female Contraception | Small molecule | Other |Viatris Inc.|Last Updated: May 6, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment1,630
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06672016Study to Evaluate Contraceptive Efficacy and Safety of a Progestin Only Patch in Women of Childbearing PotentialPHASE3 ACTIVE NOT_RECRUITING 1,630Jan 13, 2025May 1, 2027May 6, 202656 United States
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Study Endpoints
Primary Endpoints
To determine the contraceptive efficacy of progestin only patch when used over 13 cycles
13 cycles [of 4 weeks (28 days)

The primary efficacy endpoint will be pregnancy rate described by Pearl Index (PI). PI is defined as the number of pregnancies per 100 women-years.

Secondary Endpoints
To determine the efficacy in obese population (Body mass index (BMI) ≥30.0 kg/m2)
13 cycles [of 4 weeks (28 days)
To determine the efficacy in non-obese population (Body mass index (BMI) <30.0 kg/m2)
13 cycles [of 4 weeks (28 days)
Cycle-wise and cumulative pregnancy rates over 1 year
13 cycles [of 4 weeks (28 days)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
This is a single-arm study.EXPERIMENTALThe study patch is a transdermal system that contains the active ingredient progestin. This study is an open-label, single-arm study. This means that all participants in the study will receive the study patch
Interventions
NameTypeDescription
Transdermal system containing progestinDRUGMR-130A-01 transdermal system, patch to be used for female contraception
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Eligibility Criteria
Age Range16 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites56

Inclusion Criteria: 1. Healthy, post-menarcheal and premenopausal women at risk of pregnancy who are at least 16 years of age. 2. Desires to avoid pregnancy, is seeking to use hormonal contraception for at least 1 year. 3. Has negative UPT results at screening and at enrollment visits. 4. Has norma...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06672016primaryCompletionDate: changed
LOWMay 24, 2026NCT06672016studyFirstPostDate: changed