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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03117517 |
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Date of registration:
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21/03/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment With Metformin and Combination of Metformin and Pioglitazone in Polycystic Ovarian Syndrome
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Scientific title:
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Effects of Metformin and Combination of Metformin and Pioglitazone on Plasma Interleukin-6 and Interleukin-8 Levels in Polycystic Ovarian Syndrome |
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Date of first enrolment:
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March 20, 2017 |
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Target sample size:
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106 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03117517 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Care Provider, Investigator).
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Phase:
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Early Phase 1
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Mohsin Shah, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institute oF Basic Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinically diagnosed patients of PCOS.
- Must Swallow the tablet(s).
- Must give informed consent.
Exclusion Criteria:
- Women with cushing syndrome, hyperprolactinemia.
- Late onset congenital adrenal hyperplasia, androgen-producing tumors, pregnancy.
- Insulin dependent diabetes.
- Thyroid disease.
- Medications that alters the biochemical or hormonal profile.
Age minimum:
20 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Polycystic Ovarian Syndrome
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Intervention(s)
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Drug: Metformin, Pioglitazone
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Drug: Metformin
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Primary Outcome(s)
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Cytokines and Chemokines Measurements
[Time Frame: Baseline and after 3 Months]
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Secondary Outcome(s)
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Insulin Resistance
[Time Frame: Baseline and after 3 months]
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Hormonal Profiles
[Time Frame: Baseine and after 3 Months]
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Secondary ID(s)
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Protocol KMU/CTU/2016/02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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