NCT04814927

Impact of Contraceptives on Cervico-Vaginal Mucosa

The UMPALA Study: A Clinical Study to Assess the Impact of Contraceptives on the Cervico-Vaginal Mucosa

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Eastern Virginia Medical School · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This clinical study will complete approximately 12 healthy, non-pregnant, HIV-uninfected women aged 18-50 years per contraceptive arm, who are at low risk for sexually transmitted infections (STIs) at two clinical sites, for a total of approximately 96 completed participants. The study will examine changes from baseline, pre-contraceptive dosing to post contraceptive dosing of cervico-vaginal mucosal safety and adverse events. Participants at each site will be randomized (1:1:1:1) to one of four, marketed, approved contraceptive dosing forms: Levonorgestrel (LNG) 52 mg. Intrauterine System (IUS), Copper Intrauterine Device (IUD), etonogestrel (ETG, Nexplanon, Implanon) contraceptive implant, or DMPA SC contraceptive injection. Enrollment is expected to take approximately 8 months and each participant is expected to complete the study within 4 months.

Conditions

• Mucosal Inflammation
• Contraceptive; Complications, Intrauterine

Interventions

Type	Name	Description
DRUG	Copper IUD	Participants randomized to Copper IUD will receive Paragard IUD at Visit 2.
DRUG	Etonogestrel implant	Participants randomized to ETG implant will receive the implant at Visit 2.
DRUG	Levonorgestrel IUS	Participants randomized to LNG intrauterine system will receive the IUS at Visit 2.
DRUG	DMPA Sub-cutaneous	Participants randomized to DMPA SC will receive the injection at Visit 2.

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-12-15
• Completion: 2022-12-15
• First posted: 2021-03-24
• Last updated: 2023-08-25

Locations

2 sites across 2 countries: United States, Kenya

Regulatory

• FDA-regulated drug study