Effect of Fertility-sparing Therapy of Early Endometrial Cancer (ECFerSp)
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|ClinicalTrials.gov Identifier: NCT03538704|
Recruitment Status : Recruiting
First Posted : May 29, 2018
Last Update Posted : May 29, 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538704
|Contact: Jianliu Wang, Professoremail@example.com|
|Contact: Rong Zhou, Professorfirstname.lastname@example.org|
|Peking University People's Hospital||Recruiting|
|Beijing, Beijing, China, 100044|
|Contact: Jianliu Wang, Professor 010-88324381 email@example.com|
|Study Chair:||Jianliu Wang, Professor||Department of Obstetrics and Gynecology, Peking University People's Hospital|