drugset / Trial / NCT02568488

The Effect of Metformin on Different Hormones in PCOS Patients

NCT02568488 ↗

Phase 4 Completed 48 enrolled Ahmed Maged
NaSingle-groupOpen-labelTreatment

Summary

Forty eight PCOS patients were included . The diagnosis of PCOS was made based on the three criteria set by the Rotterdam Consensus meeting definition of PCOS (ESHRE, ASRM, 2004). The criteria were as follows: 1. history of chronic anovulation defined as cycle length \> 35 days, or less than 9 cycles per year or amenorrhoea (cycle length \> 12wks), 2. infertility with hirsutism or acne or elevation of one or more of serum androgen levels 3. ultrasonographic findings of polycystic ovaries ( increased ovarian volume, more than eight follicles in an ovary ranging from 2-10mm). the studied subjects were to receive metformin 850 mg twice daily over a period of 6 months. Blood samples were collected at the start of the study, before receiving metformin, where baseline serum insulin (fasting and 2 hr postprandial), sex hormone binding globulin (SHBG) , total and free testosterone, Dihydroepiandrostenedione sulphate (DHEAS) and Antimullerian Hormone (AMH) were obtained before starting metformin. Blood samples were collected at 3 and 6 months respectively of metformin treatment , to asses its effect on serum levels of the previously mentioned hormonal parameters.

Timeline

Start
2014-03
Primary completion
2015-09
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 850 mg Oral