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Seasonale

Phase 3

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

Target and mechanism

ModalitySmall molecule

Also known as Seasonale®

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

Seasonale · 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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