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Seasonale

Phase 3FDA approved 2003

Undisclosed | Small molecule | Other |Teva Pharmaceutical Industries Limited|Trials Updated: May 9, 2014

Seasonale development status

FDA approval Sep 5, 2003
Approval holderTeva Branded Pharm
ApplicationNDA021544
Highest phase Phase 3
Registered trials 1 across 1 sponsor since Nov 2001

Label indication JOLESSA ® is indicated for use by females of reproductive potential to prevent pregnancy. JOLESSA is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) FDA label

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Seasonale clinical trials

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
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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 Seasonale

What is Seasonale?

Seasonale is an oral contraceptive developed by Teva Pharmaceutical Industries Limited. It is a small molecule combination product containing levonorgestrel (LNG) and ethinyl estradiol (EE). It has been studied in a Phase 3 trial evaluating suppression of the pituitary-ovarian axis with different oral contraceptive regimens.

Who makes Seasonale?

Seasonale is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the company associated with the Seasonale brand and its clinical development program.

What phase is Seasonale in?

Seasonale has been evaluated in a completed Phase 3 clinical trial. The program includes one completed Phase 3 study, and no active trials are currently listed for Seasonale.

What clinical trials is Seasonale in?

Seasonale has been studied in the Phase 3 trial NCT00117273, titled A Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Oral Contraceptive Regimens. The trial was completed, enrolled 36 participants, was randomized, and used an active-controlled design. It was conducted in the United States.