Effects of Copper Versus Levonorgestrel Intrauterine Devices on Mucosal Microbiota and Barrier Fu… (NCT07627958) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effects of Copper Versus Levonorgestrel Intrauterine Devices on Mucosal Microbiota and Barrier Function Among Young African Women
Kenya120 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Willing and able to provide written informed consent for screening and trial participation
* Desire and willingness to use either IUD or IUS for contraception for at least one year
* Clear understanding of study randomization and commitment to use the assigned IUD
* Between 18 and 40 years of age (inclusive)
* Willing and able to actively participate in the study for 12 months
* Willing to be tested for HIV
* Sexually active
* HIV-negative
* Would benefit from STI prevention
Exclusion Criteria:
* Living with HIV or HIV screening results that are not definitively negative
* Currently pregnant or planning to become pregnant within the next 12 months
* Documented or known history of infertility or sterilization
* Prior history of ectopic pregnancy
* Use of contraceptive implant, IUD or injectable progestin in the past 3 months
* Use of oral contraceptives in the past 30 days
* Planning to use alternative contraception except condoms for the trial duration
* 0-6 weeks postpartum
* Has had a hysterectomy or sterilization
* History of challenges using and IUD/IUS, including frequent expulsion
* Medical contraindications (Category 3 or 4 criteria as detailed in the WHO MEC1 to copper IUDs or LNG-IUS, including:
* Endometrial, ovarian, or cervical cancer
* Unexplained vaginal bleeding between menstrual periods or bleeding after intercourse
* History of pelvic tuberculosis
* Anatomical abnormality of the uterus incompatible with IUD insertion
* A re…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cross-sectional comparisons of vaginal microbial Shannon alpha diversity.
Timeframe: From enrollment to the end of participation at 12 months
2
Cross-sectional comparisons of Bray-Curtis distances (Beta diversity)
Timeframe: From enrollment to the end of participation at 12 months