Effect of Fertility-sparing Therapy of Early Endometrial Cancer (ECFerSp)
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|ClinicalTrials.gov Identifier: NCT03538704|
Recruitment Status : Recruiting
First Posted : May 28, 2018
Last Update Posted : May 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer Fertility||Drug: Metformin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Fertility-sparing Therapy of Early Endometrial Cancer|
|Actual Study Start Date :||January 1, 2015|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: BMI≥25 group with metformin
Patients with BMI≥25kg/m2 in the experimental group are treated with medroxyprogesterone acetate (MPA) 0.25g/d plus metformin and are followed-up of baseline data, hormone levels,
Metformin is given to patients 1-1.5g/d.
No Intervention: BMI≥25 group without metformin
Patients with BMI≥25kg/m2 in the none intervention group are treated with MPA 0.25g/d alone and are followed-up of baseline data, hormone levels, and endometrial pathology every 3 months until 12 months.
- Complete response rate [ Time Frame: through study completion, an average of 3 months ]Histologically shows absence of pathological hyperplasia or carcinoma.
- Pregnancy rate [ Time Frame: through study completion, an average of 3 months ]Pregnancy test shows pregnancy after complete response.
- Recurrence rate [ Time Frame: through study completion, an average of 3 months ]Pathology shows atypical hyperplasia or carcinoma again after complete response.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538704
|Contact: Jianliu Wang, Professorfirstname.lastname@example.org|
|Contact: Rong Zhou, Professoremail@example.com|
|Peking University People's Hospital||Recruiting|
|Beijing, Beijing, China, 100044|
|Contact: Jianliu Wang, Professor 010-88324381 firstname.lastname@example.org|
|Study Chair:||Jianliu Wang, Professor||Department of Obstetrics and Gynecology, Peking University People's Hospital|