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

NCT02641990 · Completed

Last updated 2026-05-28

This clinical trial tests how ITCA 650, a long-acting injectable medication, affects the levels of hormones in the bloodstream from birth control pills in healthy premenopausal women.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind study

Participants 28 people

Who can join Ages 18–45 · female only Healthy volunteers accepted.

Timeline Started 2015-12 · est. completion 2016-02

Where 2 sites · United States

What this study is testing ClinicalTrials.gov NCT02641990 ↗

Description as written by the study sponsor.

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.

Treatments tested

ITCA 650 20/60 mcg/day, ITCA placebo Drug

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
ITCA placebo, ITCA 650 20/60 mcg/day Drug

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

Main thing measured	Area under the plasma concentration-time curve at steady state (AUCss) for ethinyl estradiol and levonorgestrel
Sponsor	Intarcia Therapeutics
Conditions studied	Healthy Adult Premenopausal Female Volunteers
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02641990 ↗