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100A-01

Phase 3

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

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

100A-01 · 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 100A-01

What is 100A-01 used for?

100A-01 is an investigational small molecule being developed for contraception. It is a hormonal contraceptive intended for use in healthy women, studied in a Phase 3 clinical trial for up to 13 cycles. The drug is not yet approved and remains in clinical development.

Who makes 100A-01?

100A-01 is being developed by Viatris Inc. (NASDAQ: VTRS). The company is conducting clinical trials to evaluate the safety and efficacy of this investigational contraceptive in healthy women.

What phase is 100A-01 in?

100A-01 is in Phase 3 clinical development. A Phase 3 study has been completed, evaluating the drug in 1,319 healthy women for up to 13 cycles. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is 100A-01 in?

100A-01 was studied in a completed Phase 3 trial with NCT number 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 in the United States, Canada, and Puerto Rico.

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

Yes, 100A-01 is also known as MR-100A-01. The Phase 3 clinical trial NCT05139121 uses the name MR-100A-01 in its title, confirming that both names refer to the same investigational contraceptive drug.