The Effect of Metformin on Different Hormones in PCOS Patients

Polycystic Ovarian Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02568488
• Other study ID #: 138
• Status: Completed
• Phase: Phase 4
• First received: September 30, 2015
• Last updated: March 19, 2017
• Start date: March 2014
• Est. completion date: September 2015

Study information

• Verified date: March 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 33 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovarian Syndrome
• Polycystic Ovary Syndrome

Intervention

Drug:
• Metformin
850 mg orally twice daily for 6 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ahmed Maged

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hormonal changes	total and free testosterone	Change from Baseline at 3 and 6 months
Secondary	serum insulin levels	serum insulin (fasting and 2 hr postprandial)	Change from Baseline at 3 and 6 months
Secondary	ovarian morphology	ovarian volume and number of follicles	Change from Baseline at 3 and 6 months
Secondary	sex hormone binding globulin (SHBG)		Change from Baseline at 3 and 6 months
Secondary	Antimullerian Hormone (AMH)		Change from Baseline at 3 and 6 months
Secondary	Dihydroepiandrostenedione sulphate (DHEAS)		Change from Baseline at 3 and 6 months