Health TrialsbyHealthPanel

Weight Management Plus LNG-IUS/Megestrol Acetate in Endometrial Atypical Hyperplasia

ConditionsAtypical Endometrial HyperplasiaFertility IssuesOverweight and Obesity
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorXiaojun Chen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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)

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intensive Lifestyle Intervention (ILI)

    Behavioral

    dietary guidance, exercise guidance, lifestyle intervention

  • Megestrol Acetate 160 MG Oral Tablet

    Drug

    enrolled participants will take Megestrol Acetate 160mg daily

  • Levonorgestrel-Releasing Intrauterine Contraceptive System (Mirena), 52 Mg

    Drug

    enrolled patients will be treated with LNG-IUS.

Treatment groups

172 Participants
are divided into 4 treatment groups
Group A: overweight MA+ILIExperimental treatment 2 interventions
Group B: overweight LNG-IUS+ILIExperimental treatment 2 interventions
Group C: obese MA+ILIExperimental treatment 2 interventions
Group D: obese LNG-IUS+ILIExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Pathological complete response (CR) rates

The 28-week CR rates will be calculated in four arms

Time frame
From date of recruitment until the date of CR, assessed up to 28 weeks.

Secondary outcomes

1

Pregnancy outcomes

For participants have a desire for fertility, pregnancies, births and related outcomes will be counted, and the rate of pregnancy will be counted as number of pregnancies/ number of patients trying to fertility in the following period.

Time frame
up to 2 years after complete response of the last participant
2

Weight change

The investigators will record body weight every month and calculate its change in kilograms.

Time frame
From date of recruitment, assessed up to 28 weeks.
3

Body composition change

The investigators will detect body composition with InBody machine and calculate changes of the indicated indexes.

Time frame
From date of recruitment, assessed up to 28 weeks.
4

Blood pressures change

Record blood pressures (systolic and diastolic pressures) every 12-16 weeks and count the change during the trial.

Time frame
From date of recruitment, assessed up to 28 weeks.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiaojun Chen

Lead sponsor

Fudan University

Sponsor institution

Source ClinicalTrials.gov
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