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

Phase 3FDA approved

Contraception | Hormone Therapies | Endocrine |Viatris Inc.|Trials Updated: Jan 28, 2025

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

FDA approval on record Jul 29, 2026
Highest phase Phase 3

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

ModalityHormone Therapies

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment1,319

FDA Designations

No designations recorded

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

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
ContraceptionUnlock trial analytics

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 Phase 3 development for contraception. The patch is designed to be applied weekly, and it is being studied in healthy women aged 16 years and older.

What is MR-100A-01 used for?

MR-100A-01 is being developed for contraception. It is a weekly contraceptive patch containing a low dose of estrogen. The Phase 3 trial enrolled approximately 1,200 healthy women and evaluated use for up to 13 cycles. It is not approved for any indication and remains investigational.

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 Phase 3 clinical trial evaluating the contraceptive patch. No other developer or partner is identified for this asset.

What phase is MR-100A-01 in?

MR-100A-01 is in Phase 3 development. One Phase 3 trial has been completed, and no active trials are ongoing. The completed study, NCT05139121, enrolled 1,319 healthy female participants aged 16 years and older in the United States, Canada, and Puerto Rico.

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 is completed, enrolled 1,319 participants, and was conducted in the United States, Canada, and Puerto Rico.

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

Yes, MR-100A-01 is also known as 100A-01. Both names refer to the same investigational low-dose estrogen weekly contraceptive patch developed by Viatris Inc. (ticker VTRS). The asset is in Phase 3 development for contraception.