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
About this trial
This is an interventional treatment trial for Polycystic Ovarian Syndrome
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
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
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
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