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MR-100A-01 (low-dose estrogen weekly contraceptive patch)

Phase 3

Contraception | Small molecule | Endocrine |Viatris Inc.|Last Updated: Jan 28, 2025

Target and mechanism

ModalitySmall molecule

Also known as MR-100A-01, 100A-01

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment1,319

FDA Designations

No designations recorded

Clinical trial landscape

MR-100A-01 (low-dose estrogen weekly contraceptive patch) · 1 trial · 1 indication

Phase 3 1
NCT05139121Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 CyclesContraception
COMPLETED1,319 Analytics
PHASE3COMPLETED
Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles
Contraception
NCT051391211,319
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Study Endpoints

Primary Endpoints

Contraceptive efficacy of MR-100A-01 when used over thirteen 28-day cycles in healthy, post-menarcheal, premenopausal, heterosexually active female subjects of childbearing potential who are at least 16 years of age and at risk of pregnancy
12 months (13 cycles)

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 times 100

Secondary Endpoints

Cycle-wise pregnancy rates over 1 year evaluated using life table analysis [secondary efficacy]
12 months (13 cycles)
Cumulative pregnancy rates over 1 year evaluated using life table analysis [secondary efficacy]
12 months (13 cycles)
Method failure Pearl Index (PI) [secondary efficacy]
12 months (13 cycles)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
MR-100A-01EXPERIMENTALMR-100A-01 is a transdermal delivery system designed to deliver daily hormone exposure of Norelgestromin and Ethinyl Estradiol

Interventions

NameTypeDescription
MR-100A-01DRUGTransdermal contraceptive delivery system
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Eligibility Criteria

Age Range16 Years to N/A
SexFEMALE
Healthy VolunteersYes
Study Sites100

Inclusion Criteria: 1. Healthy, post-menarcheal and premenopausal women at risk of pregnancy who are at least 16 years of age with no upper age limit. Post-menarcheal female subjects who are at risk of pregnancy, and \<18 years are eligible provided that: 1. Applicable national, state, and loca...

Countries:United StatesCanadaPuerto Rico
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Frequently asked questions about MR-100A-01 (low-dose estrogen weekly contraceptive patch)

What is MR-100A-01?

MR-100A-01 is an investigational low-dose estrogen weekly contraceptive patch developed by Viatris Inc. (ticker VTRS). It is a small molecule product in the endocrine therapeutic area being studied for contraception in healthy women. It is also known as 100A-01.

What is MR-100A-01 used for?

MR-100A-01 is being developed for contraception. It is a weekly contraceptive patch containing low-dose estrogen, studied in healthy women aged 16 years and older for up to 13 cycles of use. It is investigational and has not been approved for marketing.

Who makes MR-100A-01?

MR-100A-01 is developed by Viatris Inc., which trades under the ticker VTRS. Viatris is the sponsor of the clinical program evaluating the low-dose estrogen weekly contraceptive patch for contraception.

What phase is MR-100A-01 in?

MR-100A-01 is in Phase 3 development. Its Phase 3 trial has been completed, and the program has not reported approval. The drug remains investigational for contraception.

What clinical trials is MR-100A-01 in?

MR-100A-01 has been studied in one Phase 3 trial, NCT05139121, titled Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles. The trial enrolled 1,319 healthy female participants aged 16 years and older across the United States, Canada, and Puerto Rico, and it is completed.

Is MR-100A-01 the same as 100A-01?

Yes. MR-100A-01 and 100A-01 refer to the same investigational low-dose estrogen weekly contraceptive patch from Viatris Inc. (ticker VTRS). Searches for either name point to the same Phase 3 contraception program.