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Seasonique

Phase 3

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: May 9, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

Seasonique · 1 trial · 1 indication

Phase 3 1
NCT00117273A Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Oral Contraceptive RegimensHealthy
COMPLETED36 Analytics
PHASE3COMPLETED
A Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Oral Contraceptive Regimens
Healthy
NCT0011727336
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Study Endpoints

Primary Endpoints

Compare differences in hormone patterns (follicle stimulating hormone [FSH], luteinizing hormone [LH], inhibin-B, and estradiol)
Before, during and after the 7-day hormone free interval or EE-supplemented interval

Secondary Endpoints

Compare the differences in hormone withdrawal symptoms
Before, during and after the 7-day hormone free interval or EE-supplemented interval
Compare differences in ovarian follicular development
Before, during and after the 7-day hormone free interval or EE-supplemented intervals
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
3ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)]DRUG1 tablet daily
Seasonique (LNG/EE and EE)DRUG1 tablet daily
Portia (LNG/EE)DRUG1 tablet daily x 28 days
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Eligibility Criteria

Age Range18 Years to 35 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Premenopausal * Not pregnant or breastfeeding * Weight \<200 lbs * Currently taking oral contraceptives in the standard 28-day regimen for at least two months Exclusion Criteria: * Any contraindication to the use of oral contraceptives * Pregnancy within the last 3 months * ...

Countries:United States
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Frequently asked questions about Seasonique

What is Seasonique?

Seasonique is an investigational small molecule oral contraceptive being developed by Teva Pharmaceutical Industries Limited (TEVA). It is studied in healthy female volunteers for the suppression of the pituitary-ovarian axis. The drug is currently in Phase 3 clinical development.

What does Seasonique target?

Seasonique targets the pituitary-ovarian axis, as evaluated in a Phase 3 clinical trial. The study assessed suppression of this axis with three different oral contraceptive regimens. The drug is designed for use in healthy women as an oral contraceptive.

Who makes Seasonique?

Seasonique is being developed by Teva Pharmaceutical Industries Limited, a company traded under the ticker TEVA. The drug is currently in Phase 3 clinical development for use as an oral contraceptive in healthy women.

What phase is Seasonique in?

Seasonique is in Phase 3 clinical development. It has completed one Phase 3 trial, NCT00117273, which evaluated suppression of the pituitary-ovarian axis with three different oral contraceptive regimens in healthy female volunteers.

What clinical trials is Seasonique in?

Seasonique has one completed Phase 3 clinical trial, NCT00117273, titled 'A Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Oral Contraceptive Regimens'. The trial enrolled 36 healthy female participants in the United States, aged 18 years and older.

Is Seasonique FDA approved?

Seasonique is not FDA approved. It is an investigational drug currently in Phase 3 clinical development. The completed Phase 3 trial, NCT00117273, evaluated the drug in healthy women, but approval status has not been established.