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IUD showdown: which type keeps vaginal bacteria healthier?

NCT ID NCT07627958

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

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

18 to 40 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Partners in Health and Research Development

    Thika, Kenya