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ethinyloestradiol and levonorgestrel, CP-690, 550+ ethinyloestradiol and levonorgestrel

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Aug 6, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

ethinyloestradiol and levonorgestrel, CP-690, 550+ ethinyloestradiol and levonorgestrel · 1 trial · 1 indication

Phase 1 1
NCT01137708CP-690,550 And Oral Contraception Drug-Drug Interaction StudyHealthy
COMPLETED20 Analytics
PHASE1COMPLETED
CP-690,550 And Oral Contraception Drug-Drug Interaction Study
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Study Endpoints

Primary Endpoints

AUCinf of ethinyloestradiol (EE) and levonorgestrel (LN)
12 days

Secondary Endpoints

AUClast, Cmax, Tmax, and t½ of ethinyloestradiol (EE) and levonorgestrel (LN)
12 days
Number of adverse events and number of participants with adverse events
12 days
Changes in complete blood count and serum chemistry profile
12 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment Sequence 1EXPERIMENTAL -
Treatment Sequence 2EXPERIMENTAL -

Interventions

NameTypeDescription
ethinyloestradiol (EE) and levonorgestrel (LN), CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN)DRUGPeriod 1: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel alone Period 2: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel plus 30 mg CP-690,550 after 9 days of CP-690,550 at 30 mg BID
CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN), ethinyloestradiol (EE) and levonorgestrel (LN)DRUGPeriod 1: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel plus 30 mg CP-690,550 after 9 days of CP-690,550 at 30 mg BID Period 2: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel alone
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Eligibility Criteria

Age Range18 Years to 55 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy female subjects * No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis Exclusion Criteria: * Any medical reason which would contraindicate the administration of oral contraceptives * Clinically significant infections withi...

Countries:Belgium
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Frequently asked questions about ethinyloestradiol and levonorgestrel, CP-690, 550+ ethinyloestradiol and levonorgestrel

What is ethinyloestradiol and levonorgestrel, CP-690,550+ ethinyloestradiol and levonorgestrel?

It is a combination of ethinyloestradiol and levonorgestrel, an oral contraceptive, studied together with CP-690,550 in a Phase 1 drug-drug interaction trial. The study enrolled healthy female volunteers to assess how the two agents interact when given together. It is not a standalone product but a study combination.

Who is developing ethinyloestradiol and levonorgestrel, CP-690,550+ ethinyloestradiol and levonorgestrel?

Pfizer, Inc. (ticker: PFE) is the developer of this combination. The company sponsored the Phase 1 drug-drug interaction study evaluating CP-690,550 with ethinyloestradiol and levonorgestrel. Pfizer holds the investigational asset.

What phase is ethinyloestradiol and levonorgestrel, CP-690,550+ ethinyloestradiol and levonorgestrel in?

It is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are ongoing. The study was a controlled, randomized Phase 1 drug-drug interaction trial in healthy female volunteers.

What clinical trials is ethinyloestradiol and levonorgestrel, CP-690,550+ ethinyloestradiol and levonorgestrel in?

The combination was evaluated in one completed Phase 1 trial, NCT01137708, titled "CP-690,550 And Oral Contraception Drug-Drug Interaction Study." It enrolled 20 healthy female volunteers aged 18 years and older in Belgium. The trial was randomized, controlled, and did not use double blinding.