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NCT00399685 · ClinicalTrials.gov registry record · Phase 1

Drug Interaction - Oral Contraceptive

A Phase 1 study of HIV Infections, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 1
Development phase
28
Enrollment target
2
Study locations

NCT00399685: Completed Phase 1 study of HIV Infections, sponsored by Bristol-Myers Squibb.

NCT00399685 is a Phase 1 study of HIV Infections that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 28 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00399685, a Phase 1 study of HIV Infections, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 1
Development phase
28 participants
Enrollment target
2
Study locations

Study Summary

The purpose of this study is to administer a combined oral contraceptive containing ethinyl estradiol and norgestimate with the HIV treatment of efavirenz to healthy females in order to assess if the concentrations of the oral contraceptives change. The safety of this treatment regimen will also be studied.

Conditions Studied

Interventions

  • DRUG Ortho Tri-Cyclen LO
  • DRUG Ortho Cyclen
  • DRUG Ortho Cyclen + Efavirenz

Study Locations (2)

California

  • Covance Clinical Research Unit San Diego - San Diego

Washington

  • Northwest Kinetics - Tacoma

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2006-12
Est. Completion 2007-08
Phase Phase 1
Bristol-Myers Squibb

1,025 total trials

What the finished NCT00399685 record still lists

NCT00399685 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 446-participant average among 542 other HIV Infections trials with a reported enrollment target (94% lower).

The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which Ortho Tri-Cyclen LO is the first listed.

NCT00399685 reports a single indexed study location in California, Washington.

Frequently Asked Questions

What is clinical trial NCT00399685 about?

NCT00399685 is a clinical study titled "Drug Interaction - Oral Contraceptive". The purpose of this study is to administer a combined oral contraceptive containing ethinyl estradiol and norgestimate with the HIV treatment of efavirenz to healthy females in order to assess if the concentrations of the oral contraceptives change. The safety of this treatment regimen will also be ...

What is the current status of trial NCT00399685?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2006-12. Estimated completion is 2007-08.

What conditions does trial NCT00399685 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00399685?

The interventions under investigation include: Ortho Tri-Cyclen LO (DRUG), Ortho Cyclen (DRUG), Ortho Cyclen + Efavirenz (DRUG).

Who is sponsoring clinical trial NCT00399685?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00399685 being conducted?

This trial has 2 study locations across California, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for HIV Infections

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00399685's enrollment target sits among peer trials

28 447th of 542 higher than 94 of 542 other HIV Infections trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HIV Infections 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 NCT00399685, the US trial registry maintained by the National Library of Medicine. NCT00399685 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.