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Effects of Copper Versus Levonorgestrel Intrauterine Devices on Mucosal Microbiota and Barrier Function Among Young African Women

NCT07627958 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-06-04

No results posted yet for this study

Summary

The goal of this clinical trial is to definitively determine whether copper intrauterine device (IUD) or hormonal intrauterine system (IUS) results in greater vaginal microbial diversity after 1 year in women (n= approximately 120) aged 18-40 years, who desire to use a copper IUD or hormonal IUS as contraception, are HIV-negative and could benefit from STI prevention.

The main questions it aims to answer are:

1. Whether women assigned to copper IUD vs hormonal IUS have differences in vaginal microbial diversity after 1 year of use
2. Whether women randomized to Copper IUD have reduced genital mucosal barrier integrity as indicated by proteomic signatures
3. Whether women randomized to Copper IUD have greater incidence of high-risk HPV or curable STIs (Ct, Ng, Tv)

Participants will be assigned to have either the copper IUD or the hormonal IUS inserted as contraception. After that, they will have blood and vaginal fluids collected every 3 months for one year to look at the bacteria in their vagina, test for sexually transmitted infections, and examine markers of vaginal health.

After enrolment, each participant will be followed for 12 months, and at the end of the trial, the participant can continue to use the IUD/IUS or the study clinician can remove it.

Conditions

  • Vaginal Microbial Diversity

Interventions

DRUG

Levonorgesterel Intrauterine system (LNG IUS)

Product will be used as labeled for approximately 12 months.

DEVICE

Copper T Intrauterine device (Cu-IUD)

Product will be used as labeled for approximately 12 months.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Seattle Children's Hospital

    lead OTHER

Principal Investigators

  • Heather Jaspan, MD, PhD · Seattle Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2029-07-31
Completion
2030-07-31

Countries

  • Kenya

Study Locations

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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 NCT07627958 on ClinicalTrials.gov