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NCT00869960 · ClinicalTrials.gov registry record · Phase 4
Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in Healthy Women
A Phase 4 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 4
- Development phase
- 24
- Enrollment target
NCT00869960: Completed Phase 4 study, sponsored by University of Alabama at Birmingham.
NCT00869960 is a Phase 4 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 24 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00869960, a Phase 4 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 24 participants
- Enrollment target
Study Summary
Data suggest that women taking drugs to treat human immunodeficiency virus (HIV) have higher amounts of drugs in their body compared with men taking the same dose of anti-HIV drugs. The reason for this higher drug exposure has not been determined. The primary purpose of this study is to examine whether the pharmacokinetics (factors that determine the amount of drug in the body) of anti-HIV drugs change during different phases of the menstrual cycle in women and ultimately result in higher amounts of drug in the body compared with men. In other words, we plan to examine whether changes in sex hormones throughout the menstrual cycle affect the amount of anti-HIV drugs in women. The antiretroviral drugs atazanavir, ritonavir, tenofovir and emtricitabine will be studied. This study will be conducted in healthy women since HIV may change the pharmacokinetics of anti-HIV drugs.
Primary Outcome
Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase).
Interventions
- DRUG ritonavir
- DRUG tenofovir
- DRUG emtricitabine
- DRUG atazanavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2009-03 |
| Est. Completion | 2010-12 |
| Phase | Phase 4 |
What the finished NCT00869960 record still lists
NCT00869960 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 4 interventions - of which ritonavir is the first listed.
NCT00869960 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00869960 about?
NCT00869960 is a clinical study titled "Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in Healthy Women". Data suggest that women taking drugs to treat human immunodeficiency virus (HIV) have higher amounts of drugs in their body compared with men taking the same dose of anti-HIV drugs. The reason for this higher drug exposure has not been determined. The primary purpose of this study is to examine whet...
What is the current status of trial NCT00869960?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2009-03. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00869960?
The interventions under investigation include: ritonavir (DRUG), tenofovir (DRUG), emtricitabine (DRUG), atazanavir (DRUG).
Who is sponsoring clinical trial NCT00869960?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00869960's enrollment target sits among peer trials
24 1699th of 2000 higher than 276 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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