IUD showdown: which type keeps vaginal bacteria healthier?
NCT ID NCT07627958
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how two types of birth control devices—copper IUDs and hormonal IUDs—affect the bacteria in the vagina and the risk of infections. About 120 HIV-negative women aged 18-40 will be randomly assigned to one device and followed for a year. Researchers will collect samples every 3 months to measure changes in vaginal microbes, signs of infection, and overall vaginal health.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 40 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 recent septic abortion * Untreated mucopurulent cervicitis on exam, untreated pelvic inflammatory disease (PID), or untreated known gonorrhoea or chlamydia * Has any condition (social or medical), which in the opinion of the investigator, would make study participation unsafe or complicate data interpretation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Partners in Health and Research Development
Thika, Kenya