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New IUD combo aims to stop displacement in adenomyosis

NCT ID NCT07680985

Disease control Sponsor: Wenzhou People's Hospital Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This trial tests whether combining a hormone-releasing IUD with an anchoring IUD can prevent the device from slipping out of place in women with adenomyosis, a condition that causes pelvic pain and heavy bleeding. The study includes 270 women with different uterine cavity depths, comparing the combined device to standard IUDs or hormone therapy alone. Participants are followed for 6 months to check device stability and symptom improvement.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Levonorgestrel-releasing intrauterine system (LNG-IUS) combined with Indomethacin-GyneFix IUD
What this could lead to
If successful, this approach could reduce IUD expulsion rates, making hormone therapy more reliable for managing adenomyosis symptoms like pain and heavy bleeding.
What could go wrong
This is a single-center study with a 6-month follow-up, so long-term benefits and risks are unknown. The device combination may still fail or cause complications.

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

270 people

The number who actually took part.

Started

Jul 2023

Finished

Dec 2025

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

20 to 55 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Female patients aged 20 to 55 years. * Diagnosed with adenomyosis by transvaginal ultrasound. * No current desire for pregnancy and willing to receive conservative intrauterine treatment. * No contraindications to intrauterine device placement. * Able to understand the study procedures and voluntarily provide written informed consent. * Able and willing to comply with scheduled follow-up visits and study assessments. Exclusion Criteria: * Pregnancy or suspected pregnancy. * Concurrent malignant tumor of the reproductive system. * Severe cervical lesions or uterine malformations. * Severe coagulation disorder. * Severe hepatic or renal insufficiency. * Known hypersensitivity to levonorgestrel, copper, indomethacin, or related device components. * Uncontrolled pelvic inflammatory disease or untreated vaginal infection. * Uterine prolapse grade II or higher. * Any condition judged by the investigator to make intrauterine device placement unsuitable. * Inability to complete follow-up or incomplete key clinical data. * Withdrawal of consent during the study.

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Conditions

The condition(s) this trial relates to.

adenomyosis Dysmenorrhea Menorrhagia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adenomyosis

Contacts and locations

Locations

  • Wenzhou People's Hospital

    Wenzhou, Zhejiang, 325000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.