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NCT02531321 · ClinicalTrials.gov registry record · Phase 4
Protease Inhibitors and Combined Oral Contraceptive Pharmacokinetics and Pharmacodynamics
A Phase 4 study, sponsored by University of Southern California.
- Terminated
- Registry status
- Phase 4
- Development phase
- 17
- Enrollment target
NCT02531321: Clinical Trial Phase 4 study, sponsored by University of Southern California.
NCT02531321 is a Phase 4 study that was terminated before completion, run by University of Southern California. The registered enrollment target is 17 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02531321, a Phase 4 study, was terminated before completion, sponsored by University of Southern California.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 17 participants
- Enrollment target
Study Summary
The project is a two-arm prospective cohort and pharmacokinetic study comparing levonorgestrel and ethinyl estradiol pharmacokinetics in HIV-positive women taking antiretroviral regimens that include ritonavir to those in women who take regimens known not to interact with combined oral contraceptives. In addition, the prevalence of ovulation will be measured in each group. Participants will take a combined oral contraceptive containing levonorgestrel and ethinyl estradiol for 21 days, during which they will undergo twice-weekly serum progesterones. On the final day, they will complete a pharmacokinetic study. The investigators hypothesize that levonorgestrel levels, as measured by area-under-the-curve from 0 to 72 hours, will be increased in women on ritonavir, while ethinyl estradiol levels will be decreased and ovulation, defined by a serum progesterone of at least 3 ng/mL, will be unchanged. This study will be the first to evaluate the effects of ritonavir on the pharmacokinetics of a combined oral contraceptive containing the progestin levonorgestrel. In addition, no previous studies have rigorously assessed ovulation in women taking protease inhibitors and combined oral contraceptives. As a result, this study will provide new information correlating pharmacokinetic changes with effects on ovulation.
Primary Outcome
Levonorgestrel AUC from 0 to 72 hours
Interventions
- DRUG Levonorgestrel and Ethinyl Estradiol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2015-08 |
| Est. Completion | 2016-11-01 |
| Phase | Phase 4 |
Why NCT02531321 stopped before completion
NCT02531321 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Levonorgestrel and Ethinyl Estradiol is the first listed.
NCT02531321 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02531321 about?
NCT02531321 is a clinical study titled "Protease Inhibitors and Combined Oral Contraceptive Pharmacokinetics and Pharmacodynamics". The project is a two-arm prospective cohort and pharmacokinetic study comparing levonorgestrel and ethinyl estradiol pharmacokinetics in HIV-positive women taking antiretroviral regimens that include ritonavir to those in women who take regimens known not to interact with combined oral contraceptive...
What is the current status of trial NCT02531321?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2015-08. Estimated completion is 2016-11-01.
What interventions are being tested in trial NCT02531321?
The interventions under investigation include: Levonorgestrel and Ethinyl Estradiol (DRUG).
Who is sponsoring clinical trial NCT02531321?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02531321's enrollment target sits among peer trials
17 1854th of 2000 higher than 132 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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