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NCT02641990 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Intarcia Therapeutics.

Completed
Registry status
Phase 1
Development phase
28
Enrollment target

NCT02641990 is a Phase 1 study that has completed, run by Intarcia Therapeutics. The registered enrollment target is 28 participants.

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The verdict

NCT02641990, a Phase 1 study, has completed, sponsored by Intarcia Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
28 participants
Enrollment target

Study 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.

Interventions

  • DRUG ITCA 650 20/60 mcg/day, ITCA placebo
  • DRUG ITCA placebo, ITCA 650 20/60 mcg/day

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2015-12
Est. Completion 2016-02
Phase Phase 1

Sponsor

Intarcia Therapeutics

16 total trials

What the Registry Record Tells You About NCT02641990

The ClinicalTrials.gov registry entry for NCT02641990 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intarcia Therapeutics, which has 16 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which ITCA 650 20/60 mcg/day, ITCA placebo is the first listed.

NCT02641990 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02641990 about?

NCT02641990 is a clinical study titled "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 (PK) of once daily administration of Levora® (ethinyl estradiol 0.3 mg (EE) and levonorgestrel 0.15 mg (LNG) in healthy premenopausal female subjects.

What is the current status of trial NCT02641990?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2015-12. Estimated completion is 2016-02.

What interventions are being tested in trial NCT02641990?

The interventions under investigation include: ITCA 650 20/60 mcg/day, ITCA placebo (DRUG), ITCA placebo, ITCA 650 20/60 mcg/day (DRUG).

Who is sponsoring clinical trial NCT02641990?

This trial is sponsored by Intarcia Therapeutics, which has 16 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.