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New hormone combo aims to save fertility in early uterine cancer

NCT ID NCT05247268

Disease control Sponsor: Fudan University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase 2 trial tests whether a combination of a gonadotropin-releasing hormone agonist (triptorelin) and letrozole can achieve better complete response rates than standard hormone therapy (megestrol acetate or medroxyprogesterone acetate) in women with early-stage endometrial cancer who wish to preserve fertility. About 104 participants will be enrolled and followed for up to 28 weeks to see how well the cancer responds and to monitor side effects.

What this could mean

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

Active substance
Gonadotropin-releasing hormone agonist (triptorelin) plus letrozole
What this could lead to
If successful, this could offer a more effective fertility-sparing option for women with early endometrial cancer, helping them avoid hysterectomy and preserve the chance to have children.
What could go wrong
This is a small, early-phase trial, so results may not be conclusive. The combination therapy may cause side effects like hot flashes or joint pain, and it's not yet known if it works better than standard treatments.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 104 people

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

Started

Mar 2022

Expected to finish

Sep 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

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: * Consent informed and signed * Primarily have a confirmed diagnosis of early-stage endometrial cancer (endometrioid, grade I, without myometrial inva- sion) ) based upon endometrial biopsy, diagnostic curettage or hysteroscopy * No signs of suspicious myometrial invasion or extrauterine metastasis by enhanced magnetic resonance imaging (MRI), enhanced computed tomography (CT) or transvaginal ultrasonography (TVUS) * Have a strong desire for remaining reproductive function or uterus * 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: * Pathologically confirmed as endometrial cancer with suspicious myometrial invasion or extrauterine metastasis * Recurrent endometrial cancer * Combined with severe medical disease or severely impaired liver and kidney function * Patients with other types of endometrial cancer or other malignant tumors of the reproductive system; patients with breast cancer or other hormone- dependent tumors that cannot be used with progesterone * Those who require hysterectomy or other methods other than conservative treatment with drugs * Known or suspected pregnancy * Contraindication for Medroxyprogesterone Acetate, Megestrol Acetate, Triprorelin Acetate, Letrozole or pregnancy * Hormone treatment within 3 months before entering the trial; * Acute severe disease such as stroke or heart infarction or a history of thrombosis disease * Smoker(\>15 cigarettes a day)

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Conditions

The condition(s) this trial relates to.

endometrial cancer endometrial carcinoma endometrium neoplasm stage I endometrioid carcinoma

As listed by the trial registrant

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

Endometrial neoplasm malignant stage I

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

  • Obstetrics and Gynecology Hospital, Fudan University

    RECRUITING

    Shanghai, 200011, China