Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism (mprmih)
Primary Purpose
Menstrual Irregularities, Hyperandrogenism
Status
Unknown status
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
TAB METFORMIN
TAB PIOGLITAZONE
Sponsored by
About this trial
This is an interventional treatment trial for Menstrual Irregularities focused on measuring PCO, Metformin
Eligibility Criteria
Inclusion Criteria:
- women of age 18-40 with primary or secondary infertility.
- Polycystic ovarian syndrome daignosed using rotterdam criteria.
- Not taken any medication before for PCOS.
Exclusion Criteria:
- Women having type 1 or type 2 diabetes mellitus.
- Abnormal kidney or liver function.
- Hypertension or heart disease.
- Gonadotrophin induction or ovarian drilling before will not be included in this study.
Sites / Locations
- Dow University Hospital OJHARecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
metformin
pioglitazone
Arm Description
TAB METFORMIN 500mg TDS
TAB PIOGLITAZONE 30 mg OD
Outcomes
Primary Outcome Measures
HIRSUTISM
Hirsutism will be assessed by ferryman gallaway scoring (numerical/quantitative)
POLYCYSTIC OVARIES
assessment on ultrasound (qualitative-present/not present)
MENSTRUAL IRREGULARITIES
assessment on history(qualitative-present/not present)
BMI
weight and height will be combined to report BMI in kg/m2
Secondary Outcome Measures
SERUM FASTING INSULIN
unit of measure: uIU/ml
FASTING BLOOD SUGAR
unit of measure:mg/dl
FREE TESTOSTERONE
unit of measure :nmol/l
FREE ANDROGEN INDEX
numerical
Full Information
NCT ID
NCT03757923
First Posted
July 30, 2018
Last Updated
November 28, 2018
Sponsor
Dow University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03757923
Brief Title
Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism
Acronym
mprmih
Official Title
Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 18, 2018 (Actual)
Primary Completion Date
December 17, 2018 (Anticipated)
Study Completion Date
January 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare metformin with pioglitazone in improving menstrual irregularities and hyperandrogenism in women with PCOS so that an alternate and better treatment option will be available for hyperinsulinemia in pcos patients.
Detailed Description
This study will be a prospective, randomized, open label, multicentre study. It will be carried out in outpatients department of Obstetrics and gynecology, at the Dow university of Hospital and mamji hospital Karachi.
The study period will be of 6 months. Polycystic ovarian syndrome PCOS constitute most common endocrinopathy present in 4-7% women of reproductive age. Rotterdam criteria, diagnosis of PCOS require two of the three features: oligo and/or anovulation, clinical and/or biochemical signs of hyperandrogenism and polycystic ovaries by u/s and the absence of other endocrine conditions such as hypothyroidism, cushing syndrome, congenital adrenal hyperplasia, or hyperprolactinemia.
Insulin resistance and hyperinsulinemia may play a key role in pathogenesis of this syndrome by deregulating LH secretion at central level and increased stimulation of cytochrome p450 in ovary, hyperinsulinemia also decreases the circulating concentration of SHBG and contribute to greater concentration of free androgens in blood, cut off of insulin level for insulin resistance in Pakistani population is 9.25U/ml. On basis of evidence, Insulin sensitizing agents has been recently proposed as a useful treatment option in women with pcos, which by reducing insulin resistance and hyperinsulinemia, reduce the insulin driven ovarian and adrenal hyperandrogenism usually restoring normal LH and FSH secretion and ovulatory cycles.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menstrual Irregularities, Hyperandrogenism
Keywords
PCO, Metformin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trail
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
metformin
Arm Type
Experimental
Arm Description
TAB METFORMIN 500mg TDS
Arm Title
pioglitazone
Arm Type
Experimental
Arm Description
TAB PIOGLITAZONE 30 mg OD
Intervention Type
Drug
Intervention Name(s)
TAB METFORMIN
Intervention Description
INSULIN SENSITIZING AGENTS
Intervention Type
Drug
Intervention Name(s)
TAB PIOGLITAZONE
Intervention Description
INSULIN SENSITIZING AGENT
Primary Outcome Measure Information:
Title
HIRSUTISM
Description
Hirsutism will be assessed by ferryman gallaway scoring (numerical/quantitative)
Time Frame
3 months
Title
POLYCYSTIC OVARIES
Description
assessment on ultrasound (qualitative-present/not present)
Time Frame
3 months
Title
MENSTRUAL IRREGULARITIES
Description
assessment on history(qualitative-present/not present)
Time Frame
3 months
Title
BMI
Description
weight and height will be combined to report BMI in kg/m2
Time Frame
3 months
Secondary Outcome Measure Information:
Title
SERUM FASTING INSULIN
Description
unit of measure: uIU/ml
Time Frame
3 months
Title
FASTING BLOOD SUGAR
Description
unit of measure:mg/dl
Time Frame
3 months
Title
FREE TESTOSTERONE
Description
unit of measure :nmol/l
Time Frame
3 months
Title
FREE ANDROGEN INDEX
Description
numerical
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women of age 18-40 with primary or secondary infertility.
Polycystic ovarian syndrome daignosed using rotterdam criteria.
Not taken any medication before for PCOS.
Exclusion Criteria:
Women having type 1 or type 2 diabetes mellitus.
Abnormal kidney or liver function.
Hypertension or heart disease.
Gonadotrophin induction or ovarian drilling before will not be included in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jahan A Ainuddin
Phone
03012530961
Email
jahanaraainuddin@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bader F Zuberi, FCPS
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Dow University Hospital OJHA
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75270
Country
Pakistan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism
We'll reach out to this number within 24 hrs