Overview

The Effect of Metformin on Different Hormones in PCOS Patients

Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ahmed Maged
Treatments:
Metformin
Criteria
Inclusion Criteria:

- Non pregnant PCOS patients .

- 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).

Exclusion Criteria:

- those with prior history of glucose intolerance,

- history of gestational diabetes,

- NIDDM patients,

- cushing's syndrome,

- thyroid dysfunction,

- hyperprolactinemia,

- congenital adrenal hyperplasia

- patients on prolonged corticosteroid course, or other medications that alter the
hormonal or metabolic profile; including PCOS patients who were on OCPs or cyclic
progestagens