- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03757923
Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism (mprmih)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Jahan A Ainuddin
- Phone Number: 03012530961
- Email: jahanaraainuddin@yahoo.com
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan, 75270
- Recruiting
- Dow University Hospital OJHA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: metformin
TAB METFORMIN 500mg TDS
|
INSULIN SENSITIZING AGENTS
|
Experimental: pioglitazone
TAB PIOGLITAZONE 30 mg OD
|
INSULIN SENSITIZING AGENT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIRSUTISM
Time Frame: 3 months
|
Hirsutism will be assessed by ferryman gallaway scoring (numerical/quantitative)
|
3 months
|
POLYCYSTIC OVARIES
Time Frame: 3 months
|
assessment on ultrasound (qualitative-present/not present)
|
3 months
|
MENSTRUAL IRREGULARITIES
Time Frame: 3 months
|
assessment on history(qualitative-present/not present)
|
3 months
|
BMI
Time Frame: 3 months
|
weight and height will be combined to report BMI in kg/m2
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SERUM FASTING INSULIN
Time Frame: 3 months
|
unit of measure: uIU/ml
|
3 months
|
FASTING BLOOD SUGAR
Time Frame: 3 months
|
unit of measure:mg/dl
|
3 months
|
FREE TESTOSTERONE
Time Frame: 3 months
|
unit of measure :nmol/l
|
3 months
|
FREE ANDROGEN INDEX
Time Frame: 3 months
|
numerical
|
3 months
|
Collaborators and Investigators
Investigators
- Study Director: Bader F Zuberi, FCPS, Dow University of Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Endocrine System Diseases
- Gonadal Disorders
- 46, XX Disorders of Sex Development
- Disorders of Sex Development
- Urogenital Abnormalities
- Adrenogenital Syndrome
- Congenital Abnormalities
- Hyperandrogenism
- Menstruation Disturbances
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Metformin
- Pioglitazone
Other Study ID Numbers
- DowUHS3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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