CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 35 enrolled
Drug / intervention
Norethindrone acetatedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01667978
NCT01667978N/ACompleted

The Effect of Protease Inhibitors on the Pharmacokinetics of Oral Norethindrone Contraception

University of Southern California·interventional·Posted Aug 17, 2012·Updated Aug 20, 2015

In Brief

A clinical study evaluating Norethindrone acetate for Pregnancy and 2 related conditions. Completed, enrolled 35 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPregnancy, HIV, AIDS
CountriesUnited States

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 17, 2012
Enrollment StartJun 1, 2012
Primary CompletionSep 1, 2013
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.9 years ago

Interventions

Norethindrone acetatedrug