The Effect of Metformin on Different Hormones in PCOS Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovarian Syndrome
• Intervention / Treatment: Drug: Metformin

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 33 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: metformin; PCOS women receiving metformin 850 mg orally twice daily over a period of 6 months	Drug: Metformin; 850 mg orally twice daily for 6 months; Other Names: glucophage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hormonal changes	total and free testosterone	Change from Baseline at 3 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum insulin levels	serum insulin (fasting and 2 hr postprandial)	Change from Baseline at 3 and 6 months
ovarian morphology	ovarian volume and number of follicles	Change from Baseline at 3 and 6 months
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

Collaborators and Investigators

• Sponsor: Ahmed Maged

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (ACTUAL): September 1, 2015
• Study Completion (ACTUAL): September 1, 2015

Study Registration Dates

• First Submitted: September 30, 2015
• First Submitted That Met QC Criteria: October 2, 2015
• First Posted (ESTIMATE): October 6, 2015

Study Record Updates

• Last Update Posted (ACTUAL): March 21, 2017
• Last Update Submitted That Met QC Criteria: March 19, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: 138