Megestrol Acetate Plus Metformin in Patients With Endometrial Atypical Hyperplasia to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia
Overview[ - collapse ][ - ]
| Purpose | The purpose of this study is to see if megestrol acetate plus metformin will be more effective in returning the endometrial tissue to a normal state than megestrol acetate alone in patients with endometrial atypical hyperplasia. |
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| Condition | Endometrial Atypical Hyperplasia |
| Intervention | Drug: Megestrol acetate and metformin Drug: Megestrol acetate |
| Phase | Phase 4 |
| Sponsor | Xiaojun Chen |
| Responsible Party | Fudan University |
| ClinicalTrials.gov Identifier | NCT01968317 |
| First Received | October 16, 2013 |
| Last Updated | October 20, 2013 |
| Last verified | October 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 16, 2013 |
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| Last Updated Date | October 20, 2013 |
| Start Date | October 2013 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Pathological response rate [Time Frame: 16 weeks] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Megestrol Acetate Plus Metformin in Patients With Endometrial Atypical Hyperplasia to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia |
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| Official Title | Megestrol Acetate Plus Metformin in Patients With Endometrial Atypical Hyperplasia to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia |
| Brief Summary | The purpose of this study is to see if megestrol acetate plus metformin will be more effective in returning the endometrial tissue to a normal state than megestrol acetate alone in patients with endometrial atypical hyperplasia. |
| Detailed Description | After diagnosed of endometrial atypical hyperplasia by dilatation and curettage (D&C), patients will be enrolled. Age, waist circumstances, blood pressure, basic history of infertility, blood pressure, serum lipid level and side effects will be collected. Blood tests, including triglycerides, high density lipoprotein-cholesterol, fasting blood glucose, liver and kidney function will be performed before treatment to evacuate their metabolic conditions. Patients are randomized to 1 of 2 treatment groups. Patients will receive metformin 500 mg by mouth third daily and megestrol acetate 150 mg by mouth daily for 4 months on Arm I. Patients will receive megestrol acetate 150 mg PO daily for 4 months on Arm II. Then an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded. Complete response (CR) is defined as the reversion of endometrial atypical hyperplasia to proliferative or secretory endometrium; partial response (PR) is defined as regression to simple or complex hyperplasia without atypia; no response (NR) is defined as the persistence of the disease; and progressive disease (PD) is defined as the appearance of endometrial cancer in patients. More therapies will be needed in PR, NR or PD. After completion of study treatment, 24 weeks of oral contraceptive or an intrauterine device will be recommended for patients with CR, and they will be followed up for 2 years. In addition, we've already had a pilot study in 19 patients primarily diagnosed of endometrial atypical hyperplasia from August 2012 to April 2013. 10 patients were in Arm I and 9 patients were in Arm II. Metabolic syndrome were evaluated among all subjects. After treatment, megestrol acetate plus metformin worked better than megestrol acetate alone. But two arms showed no difference in NR patients, which may suggest metformin just worked as an antitumor drug more than an insulin sensitizer. More supportive researches are needed to verify it. |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Endometrial Atypical Hyperplasia |
| Intervention | Drug: Megestrol acetate and metformin Patients diagnosed with endometrial atypical hyperplasia will receive metformin 500 mg by mouth third daily and megestrol acetate 150 mg by mouth daily for 4 months. Other Names:
Patients diagnosed with endometrial atypical hyperplasia will receive megestrol acetate 150 mg by mouth daily for 4 months. Other Names: Megestrol acetate: Megace |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Not yet recruiting |
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| Estimated Enrollment | 106 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | October 2018 |
| Eligibility Criteria | Inclusion Criteria: - Be between the ages of 18-45 years old - Primarily have a confirmed diagnosis of endometrial atypical hyperplasia based upon D&C - Have a desire for remaining reproductive function or uterus - Need to be able to undergo correlative treatment and follow-up Exclusion Criteria: - Have a history of serious liver or renal dysfunction - Have a confirmed diagnosis of malignant tumor in genital system - Have taken oral contraceptive or other medicine for the treatment of endometrial hyperplasia in the past 6 months - Ask for removal of the uterus or other conservative treatment |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Xiaojun Chen, PhD 862163455050 cxjlh@hotmail.com |
| Location Countries | China |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01968317 |
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| Other Study ID Numbers | 134119a4500 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Fudan University |
| Study Sponsor | Xiaojun Chen |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | October 2013 |
Locations[ + expand ][ + ]
| Obstetrics and Gynecology Hospital, Fudan University | Shanghai, Shanghai, China, 200011 Contact: Xiaojun Chen, PhD | 862163455055 | cxjlh@hotmail.comNot yet recruiting |
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