The Effect of Metformin on Different Hormones in PCOS Patients

Sponsor
Ahmed Maged (Other)
Overall Status
Completed
CT.gov ID
NCT02568488
Collaborator
(none)
48
1
18

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Metformin on Serum Insulin, Androgens and AMH in PCOS Patients
Study Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Sep 1, 2015
Actual Study Completion Date :
Sep 1, 2015

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. hormonal changes [Change from Baseline at 3 and 6 months]

      total and free testosterone

    Secondary Outcome Measures

    1. serum insulin levels [Change from Baseline at 3 and 6 months]

      serum insulin (fasting and 2 hr postprandial)

    2. ovarian morphology [Change from Baseline at 3 and 6 months]

      ovarian volume and number of follicles

    3. sex hormone binding globulin (SHBG) [Change from Baseline at 3 and 6 months]

    4. Antimullerian Hormone (AMH) [Change from Baseline at 3 and 6 months]

    5. Dihydroepiandrostenedione sulphate (DHEAS) [Change from Baseline at 3 and 6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 33 Years
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ahmed Maged

    Investigators

    • Principal Investigator: Ahmed Maged, MD, Kasr Alainy medical school

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Maged, Assistant professor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT02568488
    Other Study ID Numbers:
    • 138
    First Posted:
    Oct 6, 2015
    Last Update Posted:
    Mar 21, 2017
    Last Verified:
    Mar 1, 2017
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 21, 2017