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Can weight management plus hormones reverse precancerous uterine changes and preserve fertility?

NCT ID NCT05316493

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is for overweight or obese women aged 18–45 with atypical endometrial hyperplasia, a precancerous condition of the uterine lining. Participants will receive either a levonorgestrel-releasing IUD (Mirena) or megestrol acetate pills, combined with a weight management program including diet and exercise guidance. The goal is to see if this combination can reverse the abnormal cells and allow women to later become pregnant.

What this could mean

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

Active substance
levonorgestrel intrauterine system (Mirena) or megestrol acetate oral tablet
What this could lead to
If successful, this approach could help obese women with precancerous endometrial changes avoid hysterectomy and preserve their ability to have children.
What could go wrong
This is an early-phase study with no placebo group, so results may not be definitive. The treatments have side effects, and not all participants will respond or achieve pregnancy.

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

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 172 people

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

Started

Jun 2022

Expected to finish

Feb 2027

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 45 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: 1.18 years≤age≤45years 2.BMI (body mass index) ≥24kg/m2 3.Consent informed and signed 4.Pathologically confirmed as endometrial atypical hyperplasia. Patients with endometrial specimens obtained by endometrial biopsy, diagnostic curettage or hysteroscopy and diagnosed histologically as endometrial atypical hyperplasia. If specimens are from other hospitals, they must be counseled or reconfirmed by the Department of Pathology of the Obstetrics and Gynecology Hospital of Fudan University. 5.Have a strong desire to reproduce and ask for fertility preservation or those who insist on keeping the uterus despite no reproductive requirements. 6.Have good compliance and follow-up conditions, and patients are willing to follow up in Obstetrics and Gynecology Hospital of Fudan University in time. Exclusion Criteria: 1. Combined with severe medical disease or liver or kidney dysfunction: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level elevates to 3 times or more of the upper limit of normal, kidney dysfunction (creatinine clearance \< 30 mL/min) 2. Patients are diagnosed with other malignant tumors of the reproductive system; patients with breast cancer or other hormone-dependent tumors that cannot be used with progesterone. 3. Those who have received high doses of high potency progestin or oral contraceptives within the last 3 months (or those on maintenance medication). 4. Those who require hysterectomy or other methods other than conservative treatment. 5. Known or suspected pregnancy. 6. Those who has contraindications to use progestin. 7. Deep vein thrombosis, stroke, myocardial infarction. 8. Severe joint lesions that prevent walking or movement. 9. untreated or recurrent pelvic inflammatory disease (PID) 10. an untreated or uncontrolled pelvic infection (vaginal, cervical, uterine); 11. Cervical dysplasia 12. Congenital or acquired uterine abnormalities, including uterine fibroid tumors or conditions that affect the shape of the uterus 13. allergic to the LNG-IUS components 14. uterine cavity is too large (average uterine diameter is over 7 cm) or have a history of LNG-IUS falling out. Notes: the last 6 criteria are only applied for patients with LNG-IUS.

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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

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  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

  • Obstetrics and Gynecology Hospital of Fudan University

    RECRUITING

    Shanghai, China

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