Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 4 study that was terminated before completion, run by University of Southern California. The registered enrollment target is 17 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02531321
The ClinicalTrials.gov registry entry for NCT02531321 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Levonorgestrel and Ethinyl Estradiol is the first listed.
NCT02531321 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.