Contraception and Menstrual Cycle Effect on Pharmacokinetics, Pharmacodynamics and Safety in Tenofovir Vaginal Gel Use
Condition: HIV Prevention
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Tenofovir 1% vaginal gel; Depo-medroxyprogesterone acetate (DMPA); Oral contraceptive: LNG 150 mcg and EE 30 mcg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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; DMPA is an intramuscular injectable contraceptive containing 150 mg of medroxyprogesterone acetate. It is FDA approved for 12 weeks of use per injection.; 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
Other intervention name(s): Depo-Provera
Intervention MeSH terms: Tenofovir; Medroxyprogesterone Acetate; Contraceptive Agents; Medroxyprogesterone; Contraceptives, Oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention