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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COMPLETED
PHASE4
101 participants
INTERVENTIONAL
2017-08-01
2018-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Metformin
Metformin 500mg bid in morning and evening after meals to be taken for 6 months.
Metformin Hydrochloride
Metformin Hydrochoride in the form of 500 mg tablets will be taken twice daily by participants.
OCP
OCP containing 35 microgram ethinylestradiol and 2-milligram cyproterone acetate to taken from the first day of the menstruation, oral administration of one pill daily for 21 days consecutively, then discontinue using the pill for seven days, and on the eighth day, restart taking the pill. OCP to be taken for 6 months.
Ethinyl Estradiol-cyprosterone acetate
Ethinyl Estradiol-cyprosterone acetate in the form of OCPs will be taken cyclically by the participants.
Interventions
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Ethinyl Estradiol-cyprosterone acetate
Ethinyl Estradiol-cyprosterone acetate in the form of OCPs will be taken cyclically by the participants.
Metformin Hydrochloride
Metformin Hydrochoride in the form of 500 mg tablets will be taken twice daily by participants.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Medical or surgical treatment of PCOS during the previous 3 months
* Presence of other endocrinopathies; except treated hypothyroidism on stable replacement doses of thyroid hormone
* Pregnancy, breastfeeding or desire for pregnancy during study interval (6 months)
* Inability to understand the proposal of the study precluding effective informed consent
18 Years
35 Years
FEMALE
No
Sponsors
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S.C.B. Medical College and Hospital
OTHER
Responsible Party
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Principal Investigators
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Priyadarshini Tripathy, MD
Role: PRINCIPAL_INVESTIGATOR
SCB Medical College
Locations
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SCB Medical College
Cuttack, Odisha, India
Countries
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Other Identifiers
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OG/2017/12
Identifier Type: -
Identifier Source: org_study_id
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