Trials / Withdrawn
WithdrawnNCT00998725
Combined Oral Contraceptive (COC) Antiretroviral (ARV) Pharmacokinetics (PK) and Pharmacodynamics (PD) in Malawi
A Pilot Study of Pharmacokinetic and Pharmacodynamic Activity of LoFemenal
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- University of North Carolina, Chapel Hill · Academic / Other
- Sex
- Female
- Age
- 21 Years – 35 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this research study is to learn about the birth control pill called LoFemenal in HIV+ and HIV negative women who live in Malawi. This is a pilot study to determine the effect of antiretroviral therapy on the pharmacokinetics of the most commonly used oral contraceptive in HIV+ women; and to measure ovulation suppression in women taking the oral contraceptive pill and antiretroviral therapy at the same time. Nine women will be enrolled and will be followed for a total of 4 months.
Conditions
Timeline
- Start date
- 2009-11-01
- Primary completion
- 2011-01-01
- Completion
- 2011-01-01
- First posted
- 2009-10-20
- Last updated
- 2017-02-17
Locations
1 site across 1 country: Malawi
Source: ClinicalTrials.gov record NCT00998725. Inclusion in this directory is not an endorsement.