Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism
NCT ID: NCT03757923
Last Updated: 2018-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
110 participants
INTERVENTIONAL
2018-06-18
2019-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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metformin
TAB METFORMIN 500mg TDS
TAB METFORMIN
INSULIN SENSITIZING AGENTS
pioglitazone
TAB PIOGLITAZONE 30 mg OD
TAB PIOGLITAZONE
INSULIN SENSITIZING AGENT
Interventions
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TAB METFORMIN
INSULIN SENSITIZING AGENTS
TAB PIOGLITAZONE
INSULIN SENSITIZING AGENT
Eligibility Criteria
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Inclusion Criteria
2. Polycystic ovarian syndrome daignosed using rotterdam criteria.
3. Not taken any medication before for PCOS.
Exclusion Criteria
2. Abnormal kidney or liver function.
3. Hypertension or heart disease.
4. Gonadotrophin induction or ovarian drilling before will not be included in this study.
18 Years
40 Years
FEMALE
No
Sponsors
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Dow University of Health Sciences
OTHER
Responsible Party
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Jahan Ara Ainuddin
Professor
Principal Investigators
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Bader F Zuberi, FCPS
Role: STUDY_DIRECTOR
Dow University of Health Sciences
Locations
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Dow University Hospital OJHA
Karachi, Sindh, Pakistan
Countries
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Central Contacts
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Other Identifiers
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DowUHS3
Identifier Type: -
Identifier Source: org_study_id
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