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The Effect of Metformin on Different Hormones in PCOS Patients

The Effect of Metformin on Serum Insulin, Androgens and AMH in PCOS Patients

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02568488
Enrollment
48
Registered
2015-10-06
Start date
2014-03-31
Completion date
2015-09-30
Last updated
2017-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovarian Syndrome

Brief 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.

Detailed description

Forty eight PCOS patients attending the OBGYN clinic at kasr al aini were included in the study. 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. The effect of metformin on PCOS patients regarding its clinical and radiological parameters was also assessed. Each patient was asked to keep a diary of her menstrual periods over the study period; to elicit if there could be an effect by metformin on the regulation of menstrual cycles secondary to improvement of ovarian function as a result of improving insulin resistance in such patients. The effect of metformin on ovarian morphology by ultrasound was also assessed at baseline, 3months and 6 months of the study period; ovarian volume and number of follicles was noted down at each visit.

Interventions

DRUGMetformin

850 mg orally twice daily for 6 months

Sponsors

Ahmed Maged
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 33 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
hormonal changesChange from Baseline at 3 and 6 monthstotal and free testosterone

Secondary

MeasureTime frameDescription
serum insulin levelsChange from Baseline at 3 and 6 monthsserum insulin (fasting and 2 hr postprandial)
ovarian morphologyChange from Baseline at 3 and 6 monthsovarian volume and number of follicles
sex hormone binding globulin (SHBG)Change from Baseline at 3 and 6 months
Antimullerian Hormone (AMH)Change from Baseline at 3 and 6 months
Dihydroepiandrostenedione sulphate (DHEAS)Change from Baseline at 3 and 6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026