NCT01421368

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

Assessing the Effect of Contraception and the Menstrual Cycle on Pharmacokinetics, Pharmacodynamics, and Vaginal Safety in Tenofovir Vaginal Gel Users

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: CONRAD · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to examine the effects of two contraceptive methods and the menstrual cycle on the pharmacokinetics, pharmacodynamics of tenofovir 1% gel and the effect of the contraceptive methods on markers of mucosal safety.

Detailed description

Each woman will be seen in 6 visits and will be contacted by two scheduled follow-up telephone calls/visits. Volunteers will be consented at Visit 1 and undergo procedures to assess whether they are eligible to continue in the study. At Visit 2 (cycle days 20-25), after it has been confirmed that the participant meets all of the inclusion criteria and none of the exclusion criteria, genital samples will be taken and she will be given 2 applicators of tenofovir 1% gel to insert two hours apart. She will be instructed to return for Visit 3, approximately 3 or 11 hours after insertion of the second gel, as determined by randomization. The participant will retain this sampling assignment throughout the study. At Visit 3 (cycle days 20-25), blood and genital samples will be collected. The participant will again be given 2 applicators of tenofovir 1% gel to insert two hours apart. She will be instructed to return approximately 3 or 11 hours after insertion of the second gel for Visit 4 (cycle days 5-10) and blood and genital samples will be taken. The participant will then start the contraceptive method that she has chosen from the two methods being evaluated in the study. Each participant will be contacted about 4-5 weeks after Visit 4 to confirm the next visit date (Visit 5). Visit 5 will take place about 6 weeks after starting contraception and will not have an associated gel use. Follow-up genital samples will be collected at Visit 5. The participant will be given 2 applicators of tenofovir 1% gel to insert two hours apart prior to Visit 6. Visit 6 will take place about 10 weeks after starting contraception. Follow-up blood and genital samples will be collected approximately 3 or 11 hours after insertion of the second gel. Each participant also will have a follow-up call or visit approximately 1-2 weeks after Visit 6 to confirm that there have been no adverse experiences. If necessary, she may be seen in an unscheduled visit for follow-up. She will then be exited from the study.

Conditions

• HIV Prevention

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2011-08-22
• Last updated: 2015-04-10

Locations

3 sites across 2 countries: United States, Dominican Republic