Non-atypical endometrial hyperplasia. Benign endometrial hyperplasia
Conditions
Interventions
Intervention 1: Intervention group: Megestrol acetate plus metformin: Megestrol acetate 40 mg orally daily plus metformin 500 mg orally three times a day for 6 months. Intervention 2: Intervention gro
Sponsors
Kashan University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Age more than 18 years old Diagnosed with Atypical Endometrial Hyperplasia which is Confirmed Histopathological through either endometrial biopsy or abortion without concomitant malignancy
Exclusion criteria
Exclusion criteria: History or concomitant diagnosis of Endometrial carcinoma or other malignancies History of thromboembolic events or contraindications for hormonal therapy Current or within recent three months of use of metformin or hormonal therapy Severe systemic diseases (such as diabetes mellitus, Hepatic failure, or kidney failure) or serum creatinine more than 1.4 mg/dl Pregnancy or lactation at the time of inclusion in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response to treatment: This variable is defined as the complete elimination of the non-atypical endometrial hyperplasia lesion in the histopathological examination of the endometrium. In such a way that in the endometrial biopsy specimen taken 6 months after the start of the intervention, no evidence of endometrial hyperplasia (including increased glandular to stroma ratio, irregular glandular architecture, or abnormal proliferative changes) is observed and a normal histological pattern or secretory/atrophic endometrium is reported. This variable is recorded as a binary (yes/no); meaning that patients who meet the above criteria are considered as "having a complete response" and other patients are considered as "lacking a complete response". The complete response variable is the primary outcome of the study and the sample size calculation was also performed based on the expected difference in complete response rates between the treatment groups. Timepoint: 6 months after intervention. Method of measurement: Endometrial biopsy and histopathological examination by a pathologist. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNegar Babaiean Ghamsari
Kashan University of Medical Sciences
Outcome results
None listed