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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: Completed Phase 1 study, sponsored by Intarcia Therapeutics.

NCT02641990 is a Phase 1 study that has completed, run by Intarcia Therapeutics. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.

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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
Intarcia Therapeutics

16 total trials

What the finished NCT02641990 record still lists

NCT02641990 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).

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 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02641990's enrollment target sits among peer trials

28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02641990, the US trial registry maintained by the National Library of Medicine. NCT02641990 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.