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New treatment option for Atypical Endometrial Hyperplasia
Official title Weight Management Plus LNG-IUS/Megestrol Acetate in Endometrial Atypical Hyperplasia
ClinicalTrials.gov ID: NCT05316493
What this study is testing
What is Megestrol Acetate 160 MG Oral Tablet?
Megestrol Acetate 160 MG Oral Tablet is an investigational medicine, given as an once-daily, being studied as a potential treatment for atypical endometrial hyperplasia.
Also referred to as yilizhi.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To investigate the efficacy of weight management plus levonorgestrel intrauterine system (LNG-IUS) or megestrol acetate (MA) in obese patients with endometrial atypical hyperplasia (EAH) asking for conservative therapy.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- 1.18 years≤age≤45years 2.BMI (body mass index) ≥24kg/m2 3.Consent informed and signed 4.Pathologically confirmed as endometrial atypical hyperplasia...
- 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...
You likely can't join if
- Combined with severe medical disease or liver or kidney dysfunction: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level...
- Patients are diagnosed with other malignant tumors of the reproductive system; patients with breast cancer or other hormone-dependent tumors that...
- Those who have received high doses of high potency progestin or oral contraceptives within the last 3 months (or those on maintenance medication).
- Those who require hysterectomy or other methods other than conservative treatment.
- Known or suspected pregnancy.
- Those who has contraindications to use progestin.
See the full eligibility 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...
- 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.
- 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...
- 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.
- Those who have received high doses of high potency progestin or oral contraceptives within the last 3 months (or those on maintenance medication).
- Those who require hysterectomy or other methods other than conservative treatment.
- Known or suspected pregnancy.
- Those who has contraindications to use progestin.
- Deep vein thrombosis, stroke, myocardial infarction.
- Severe joint lesions that prevent walking or movement.
- untreated or recurrent pelvic inflammatory disease (PID)
- an untreated or uncontrolled pelvic infection (vaginal, cervical, uterine);
- Cervical dysplasia
- Congenital or acquired uterine abnormalities, including uterine fibroid tumors or conditions that affect the shape of the uterus
- allergic to the LNG-IUS components
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.