drugset / Trial / NCT04814927
Impact of Contraceptives on Cervico-Vaginal Mucosa
Phase 4
Completed
112 enrolled
Eastern Virginia Medical School
CONRAD · collabKenya Medical Research Institute · collabUnited States Agency for International Development (USAID) · collab
Non-randomizedParallel-groupSingle-blindBasic science
Summary
UMPALA is a research study to look at the effect of four different, approved contraceptives on the cervical and vaginal tissues as well as on factors in the blood. Participants will have a baseline examination then receive one of four approved, marketed contraceptive products. Cervico-vaginal assessments will take place 4 weeks after contraceptive initiation and 3 months after to assess changes in mucosal safety after use of various contraceptive products in young, healthy, HIV uninfected women.
Timeline
- Start
- 2021-03-01
- Primary completion
- 2022-12-15
- Completion
- 2022-12-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Etonogestrel | Unknown | 68 mg | Other |
| Comparator | Levonorgestrel | Small molecule | 52 mg | Other |
| Comparator | medroxyprogesterone acetate | Other / unclassified | 104 mg | Subcutaneous |