Study S002345

A Phase 1, Randomized, Double-blind, Placebo-Controlled, Crossover Study to Assess the Effect of ITCA 650 on the Pharmacokinetics and Pharmacodynamics of a Combination Oral Contraceptive in Healthy Premenopausal Female Subjects

ClinicalTrials.gov record

Registration

Registration: NCT02641990
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 28
Start: 2015-12
Primary completion: 2016-02
Lead sponsor: Intarcia Therapeutics
Conditions: Healthy Adult Premenopausal Female Volunteers
Interventions: DRUG:ITCA 650 20/60 mcg/day, ITCA placebo; DRUG:ITCA placebo, ITCA 650 20/60 mcg/day
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Area under the plasma concentration-time curve at steady state (AUCss) for ethinyl estradiol and levonorgestrel [from baseline to 13 weeks]
Maximum steady state plasma concentration (Cmax,ss) for ethinyl estradiol and levonorgestrel [from baseline to 13 weeks]

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