MedTrace Logo

Impact of Contraceptives on Cervico-Vaginal Mucosa

NCT04814927 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2023-08-25

No results posted yet for this study

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.

Conditions

  • Mucosal Inflammation
  • Contraceptive; Complications, Intrauterine

Interventions

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.

Sponsors & Collaborators

  • CONRAD

    collaborator OTHER

  • Kenya Medical Research Institute

    collaborator OTHER

  • United States Agency for International Development (USAID)

    collaborator FED

  • Eastern Virginia Medical School

    lead OTHER

Principal Investigators

  • Andrea Thurman · Eastern Virginia Medical School, CONRAD

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2022-12-15
Completion
2022-12-15
FDA Drug
Yes

Countries

  • United States
  • Kenya

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04814927 on ClinicalTrials.gov