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NCT01667978 · ClinicalTrials.gov registry record · NA
The Effect of Protease Inhibitors on the Pharmacokinetics of Oral Norethindrone Contraception
A NA study, sponsored by University of Southern California.
- Completed
- Registry status
- NA
- Development phase
- 35
- Enrollment target
NCT01667978: Completed NA study, sponsored by University of Southern California.
NCT01667978 is a NA study that has completed, run by University of Southern California. The registered enrollment target is 35 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01667978, a NA study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
Study Summary
The purpose of this study is to learn if women taking the atazanavir and ritonavir have lower levels of a birth control medication called norethindrone. Norethindrone (also called the mini pill) is an FDA (Food and Drug Administration) approved progestin-only birth control pill used to prevent pregnancy. Norethindrone is the standard medication used in women who take the progestin only pill to prevent pregnancy. There are other birth control pills which contain different medications. The investigators want to learn if HIV medications (atazanavir and ritonavir) make the blood level of this birth control pill higher or lower. If the levels of norethindrone are too low it may not work to prevent pregnancy. The investigators also hope to learn about changes in the vaginal fluids and cervical fluids when women are taking this birth control pill.
Primary Outcome
0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 21
Interventions
- DRUG Norethindrone acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2012-06 |
| Est. Completion | 2014-09 |
| Phase | NA |
What the finished NCT01667978 record still lists
NCT01667978 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Norethindrone acetate is the first listed.
NCT01667978 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01667978 about?
NCT01667978 is a clinical study titled "The Effect of Protease Inhibitors on the Pharmacokinetics of Oral Norethindrone Contraception". The purpose of this study is to learn if women taking the atazanavir and ritonavir have lower levels of a birth control medication called norethindrone. Norethindrone (also called the mini pill) is an FDA (Food and Drug Administration) approved progestin-only birth control pill used to prevent pregn...
What is the current status of trial NCT01667978?
This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2012-06. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01667978?
The interventions under investigation include: Norethindrone acetate (DRUG).
Who is sponsoring clinical trial NCT01667978?
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 NCT01667978's enrollment target sits among peer trials
35 1564th of 2000 higher than 431 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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