Contraception and Menstrual Cycle Effect on Pharmacokinetics, Pharmacodynamics and Safety in Tenofovir Vaginal Gel Use

PHASE1CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

March 31, 2014

Study Completion Date

March 31, 2014

Conditions
HIV Prevention
Interventions
DRUG

Tenofovir 1% vaginal gel

Tenofovir 1% gel is supplied as a clear, transparent, viscous gel packaged in pre-filled single use applicators. Each applicator contains 4.0 mL of tenofovir gel (equal to 4.4 gm) at a concentration of 1% (weight for weight) formulated in purified water with edetate disodium, citric acid, glycerin, methylparaben, propylparaben and hydroxyethylcellulose, and is pH adjusted to 4-5

DRUG

Depo-medroxyprogesterone acetate (DMPA)

DMPA is an intramuscular injectable contraceptive containing 150 mg of medroxyprogesterone acetate. It is FDA approved for 12 weeks of use per injection.

DRUG

Oral contraceptive: LNG 150 mcg and EE 30 mcg

Each pill contains LNG 150 mcg (the active levorotatory enantiomer of norgestrel) and EE 30 mcg. Each pack contains 21 active pills and 7 placebo pills

Trial Locations (3)

15213

University of Pittsburgh School of Medicine, Center for Family Planning Research, Pittsburgh

23507

Easter Virginia Medical School, Norfolk

Unknown

Profamilia, Santo Domingo

All Listed Sponsors
lead

CONRAD

OTHER

NCT01421368 - Contraception and Menstrual Cycle Effect on Pharmacokinetics, Pharmacodynamics and Safety in Tenofovir Vaginal Gel Use | Biotech Hunter | Biotech Hunter