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Norelgestromin/Ethinylestradiol

Phase 3

Contraception | Small molecule | Endocrine |Bayer AG|Last Updated: Apr 2, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment393

FDA Designations

No designations recorded

Clinical trial landscape

Norelgestromin/Ethinylestradiol · 1 trial · 1 indication

Phase 3 1
NCT00984789Birth Control Patch StudyContraception
COMPLETED393 Analytics
PHASE3COMPLETED
Birth Control Patch Study
ContraceptionUnlock trial analytics

Study Endpoints

Primary Endpoints

Bleeding Patterns and cycle control
7 cycles (each consisting of 28 days)

Secondary Endpoints

Contraceptive efficacy
7 cycles (each consisting of 28 days) + follow up period of 14 days
Adverse Event Collection
7 cycles (each consisting of 28 days)
Population pharmacokinetics
7 cycles (each consisting of 28 days)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016)DRUG0.55mg ethinylestradiol and 2.1mg gestodene
Norelgestromin/Ethinylestradiol (EVRA)DRUG0.6mg ethinylestradiol and 6mg norelgestromin
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Eligibility Criteria

Age Range18 Years to 35 Years
SexFEMALE
Healthy VolunteersYes
Study Sites23

Inclusion Criteria: * Healthy women requesting contraception aged 18-35 years old * Smokers must not be older than 30 at time of informed consent * History of regular cyclic menstrual periods, normal cervical smear Exclusion Criteria: * Pregnancy or lactation * Obesity (BMI\>30), hypersensitivity...

Countries:AustriaCzechiaNetherlands
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Frequently asked questions about Norelgestromin/Ethinylestradiol

What is Norelgestromin/Ethinylestradiol used for?

Norelgestromin/Ethinylestradiol is a combination hormonal contraceptive used to prevent pregnancy. It is being developed as a birth control patch for use in women. The drug is currently in Phase 3 clinical development for the indication of contraception.

Who makes Norelgestromin/Ethinylestradiol?

Norelgestromin/Ethinylestradiol is being developed by Bayer AG, a pharmaceutical company traded on the OTC market under the ticker BAYRY. The drug is in Phase 3 clinical development for contraception.

What phase is Norelgestromin/Ethinylestradiol in?

Norelgestromin/Ethinylestradiol is in Phase 3 clinical development. It is an investigational drug for contraception and has not been approved by regulatory authorities. A Phase 3 clinical trial for the drug has been completed.

What clinical trials is Norelgestromin/Ethinylestradiol in?

Norelgestromin/Ethinylestradiol has one completed Phase 3 clinical trial, identified as NCT00984789, titled "Birth Control Patch Study." The trial enrolled 393 female participants aged 18 years and older and was conducted in Austria, Czechia, and the Netherlands.

How does Norelgestromin/Ethinylestradiol work?

Norelgestromin/Ethinylestradiol is a combination of two hormones, norelgestromin and ethinylestradiol, which work together to prevent ovulation and thicken cervical mucus, making it harder for sperm to reach an egg. It is delivered through a patch applied to the skin.