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130A-01 patch

Phase 2

Contraception | Small molecule | Endocrine |Viatris Inc.|Last Updated: Nov 29, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment168

FDA Designations

No designations recorded

Clinical trial landscape

130A-01 patch · 1 trial · 1 indication

Phase 2 1
NCT06048536Dose-finding Study of MR-130A-01 Contraceptive Transdermal PatchContraception
COMPLETED168 Analytics
PHASE2COMPLETED
Dose-finding Study of MR-130A-01 Contraceptive Transdermal Patch
Contraception
NCT06048536168
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Study Endpoints

Primary Endpoints

Proportion of responder overall (subjects with no ovulation in both treatment cycles)
56 days

A responder is a subject with no ovulation. A responder is a subject with no ovulation. Ovulation during treatment is defined as a Hoogland-Skouby score 5 or 6 in combination with fulfilment of Landgren criterion.

Proportion of responder in cycle (subjects with no ovulation in one of the treatment cycles)
56 days

A responder is a subject with no ovulation. A responder is a subject with no ovulation. Ovulation during treatment is defined as a Hoogland-Skouby score 5 or 6 in combination with fulfilment of Landgren criterion.

Secondary Endpoints

For assessment of ovarian activity, Hoogland and Skouby score frequency analysis will be provided for:
56 days
Corpus luteum function will be evaluated in subjects by using Landgren criteria in conjunction with Hoogland and Skouby score. Frequency analysis will be provided for:
56 days
The diameter of the largest FLS in both the right and left ovary will be measured (for each, the mean diameter from two directions). The largest of all follicles is considered the dominant FLS (FLSdom) for that study day.
56 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Norelgestromin low dose 2.43mg 28/0 regimen non-ObeseEXPERIMENTAL -
Norelgestromin mid dose 3.64mg 28/0 regimen non-ObeseEXPERIMENTAL -
Norelgestromin high dose 4.86mg 28/0 regimen non-ObeseEXPERIMENTAL -
Norelgestromin high dose 4.86mg 21/7 regimen non-ObeseEXPERIMENTAL -
Norelgestromin mid dose 3.64mg 28/0 regimen ObeseEXPERIMENTAL -
Norelgestromin high dose 4.86mg 28/0 regimen ObeseEXPERIMENTAL -
Norelgestromin high dose 4.86mg 21/7 regimen ObeseEXPERIMENTAL -

Interventions

NameTypeDescription
MR-130A-01 Transdermal patchDRUGMR-130A-01 transdermal patch, containing 2.43 mg Norelgestromin, will be worn 28 days per cycle with no patch free period.
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Eligibility Criteria

Age Range18 Years to 35 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy, post-menarcheal and premenopausal women of age 18 to 35 years inclusive). 2. BMI ≥18.0 kg/m2 at screening examination. 3. Subjects must be in good physical and mental health as determined by vital signs, medical history, and physical and gynecological examination, as...

Countries:Germany
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Frequently asked questions about 130A-01 patch

What is 130A-01 patch used for?

130A-01 patch is an investigational contraceptive transdermal patch being developed for contraception. It is a small molecule product in Phase 2 clinical development. The patch is designed for use in women aged 18 years and older, and it is being studied as a method of birth control.

Who makes 130A-01 patch?

130A-01 patch is being developed by Viatris Inc., a pharmaceutical company traded on the NASDAQ under the ticker symbol VTRS. The company is conducting clinical trials to evaluate the safety and efficacy of this contraceptive patch.

What phase is 130A-01 patch in?

130A-01 patch is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness for contraception.

What clinical trials is 130A-01 patch in?

130A-01 patch has one completed Phase 2 clinical trial, identified as NCT06048536, titled 'Dose-finding Study of MR-130A-01 Contraceptive Transdermal Patch'. This randomized, controlled study enrolled 168 healthy female participants in Germany, aged 18 years and older.

Is 130A-01 patch the same as MR-130A-01?

Yes, 130A-01 patch is also known as MR-130A-01. The clinical trial NCT06048536 refers to the drug as MR-130A-01, indicating that these names are used interchangeably for the same investigational contraceptive transdermal patch.

How does 130A-01 patch work?

130A-01 patch is a small molecule contraceptive delivered through a transdermal patch. The specific molecular target or mechanism of action has not been disclosed in available information. The patch is designed to provide contraception when applied to the skin.