search
Back to results

The Effect of Metformin on Different Hormones in PCOS Patients

Primary Purpose

Polycystic Ovarian Syndrome

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Metformin
Sponsored by
Ahmed Maged
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovarian Syndrome

Eligibility Criteria

18 Years - 33 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    metformin

    Arm Description

    PCOS women receiving metformin 850 mg orally twice daily over a period of 6 months

    Outcomes

    Primary Outcome Measures

    hormonal changes
    total and free testosterone

    Secondary Outcome Measures

    serum insulin levels
    serum insulin (fasting and 2 hr postprandial)
    ovarian morphology
    ovarian volume and number of follicles
    sex hormone binding globulin (SHBG)
    Antimullerian Hormone (AMH)
    Dihydroepiandrostenedione sulphate (DHEAS)

    Full Information

    First Posted
    September 30, 2015
    Last Updated
    March 19, 2017
    Sponsor
    Ahmed Maged
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02568488
    Brief Title
    The Effect of Metformin on Different Hormones in PCOS Patients
    Official Title
    The Effect of Metformin on Serum Insulin, Androgens and AMH in PCOS Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2014 (undefined)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    September 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Ahmed Maged

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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: history of chronic anovulation defined as cycle length > 35 days, or less than 9 cycles per year or amenorrhoea (cycle length > 12wks), infertility with hirsutism or acne or elevation of one or more of serum androgen levels 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: history of chronic anovulation defined as cycle length > 35 days, or less than 9 cycles per year or amenorrhoea (cycle length > 12wks), infertility with hirsutism or acne or elevation of one or more of serum androgen levels 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Polycystic Ovarian Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    metformin
    Arm Type
    Experimental
    Arm Description
    PCOS women receiving metformin 850 mg orally twice daily over a period of 6 months
    Intervention Type
    Drug
    Intervention Name(s)
    Metformin
    Other Intervention Name(s)
    glucophage
    Intervention Description
    850 mg orally twice daily for 6 months
    Primary Outcome Measure Information:
    Title
    hormonal changes
    Description
    total and free testosterone
    Time Frame
    Change from Baseline at 3 and 6 months
    Secondary Outcome Measure Information:
    Title
    serum insulin levels
    Description
    serum insulin (fasting and 2 hr postprandial)
    Time Frame
    Change from Baseline at 3 and 6 months
    Title
    ovarian morphology
    Description
    ovarian volume and number of follicles
    Time Frame
    Change from Baseline at 3 and 6 months
    Title
    sex hormone binding globulin (SHBG)
    Time Frame
    Change from Baseline at 3 and 6 months
    Title
    Antimullerian Hormone (AMH)
    Time Frame
    Change from Baseline at 3 and 6 months
    Title
    Dihydroepiandrostenedione sulphate (DHEAS)
    Time Frame
    Change from Baseline at 3 and 6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    33 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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: history of chronic anovulation defined as cycle length > 35 days, or less than 9 cycles per year or amenorrhoea (cycle length > 12wks), infertility with hirsutism or acne or elevation of one or more of serum androgen levels 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahmed Maged, MD
    Organizational Affiliation
    Kasr Alainy medical school
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Effect of Metformin on Different Hormones in PCOS Patients

    We'll reach out to this number within 24 hrs