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NCT00357604 · ClinicalTrials.gov registry record · Phase 1

Atazanavir and Ritonavir (ATV/RTV) and an Oral Contraceptive in Healthy Females

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

Completed
Registry status
Phase 1
Development phase
22
Enrollment target

NCT00357604: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.

NCT00357604 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00357604, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 1
Development phase
22 participants
Enrollment target

Study Summary

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

Interventions

  • DRUG Ortho Tri-Cyclen (ethinyl estradiol + norgestimate)
  • DRUG Ortho Tri-Cyclen LO (ethinyl estradiol + norgestimate) + Atazanavir/Ritonavir for 14 days then Ortho Tri-Cyclen for 7 days

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2006-07
Est. Completion 2006-11
Phase Phase 1
Bristol-Myers Squibb

1,025 total trials

What the finished NCT00357604 record still lists

NCT00357604 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).

The record links to 0 conditions, and to 2 interventions - of which Ortho Tri-Cyclen (ethinyl estradiol + norgestimate) is the first listed.

NCT00357604 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00357604 about?

NCT00357604 is a clinical study titled "Atazanavir and Ritonavir (ATV/RTV) and an Oral Contraceptive in Healthy Females". The purpose of this study is to administer a combined oral contraceptive (ethinyl estradiol and norgestimate) with the HIV treatment of atazanavir and ritonavir to healthy females in order to assess if the concentrations of the oral contraceptive change. The safety of this treatment regimen will als...

What is the current status of trial NCT00357604?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2006-07. Estimated completion is 2006-11.

What interventions are being tested in trial NCT00357604?

The interventions under investigation include: Ortho Tri-Cyclen (ethinyl estradiol + norgestimate) (DRUG), Ortho Tri-Cyclen LO (ethinyl estradiol + norgestimate) + Atazanavir/Ritonavir for 14 days then Ortho Tri-Cyclen for 7 days (DRUG).

Who is sponsoring clinical trial NCT00357604?

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

How this trial's enrollment target compares

Where NCT00357604's enrollment target sits among peer trials

22 1601st of 2000 higher than 386 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 NCT00357604, the US trial registry maintained by the National Library of Medicine. NCT00357604 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.