NCT02641990

Study of the Effect of ITCA 650 on the PK/PD of Oral Contraceptive in Healthy Female Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Intarcia Therapeutics · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, randomized, double-blind, placebo-controlled, crossover study to assess the effect of ITCA 650 on the pharmacokinetics (PK) of once daily administration of Levora® (ethinyl estradiol 0.3 mg (EE) and levonorgestrel 0.15 mg (LNG) in healthy premenopausal female subjects.

Conditions

• Healthy Adult Premenopausal Female Volunteers

Interventions

Type	Name	Description
DRUG	ITCA 650 20/60 mcg/day, ITCA placebo	ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day and Levora® for 28 days, followed by ITCA osmotic mini pump delivering placebo and Levora® for 28 days
DRUG	ITCA placebo, ITCA 650 20/60 mcg/day	ITCA osmotic mini pump delivering placebo and Levora® for 28 days, followed by Levora® and ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day and Levora® for 28 days

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2015-12-30
• Last updated: 2016-03-22

Locations

2 sites across 1 country: United States