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Clinical Trials/SLCTR/2015/007
SLCTR/2015/007
Completed
Phase 3

A Randomized Controlled Trial to compare the effectiveness of cyproterone acetate /ethinyl estradiol, desogestrel / ethinyl estradiol and metformin on improving hirsutism, hormonal and metabolic features of polycystic ovary syndrome.

niversity Grants Commission, Sri Lanka0 sites100 target enrollmentTBD
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Conditionspolycystic ovary syndrome

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
polycystic ovary syndrome
Sponsor
niversity Grants Commission, Sri Lanka
Enrollment
100
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
niversity Grants Commission, Sri Lanka

Eligibility Criteria

Inclusion Criteria

  • •1\.Age more than 18 years and less than 40 years
  • •2\.Diagnosis of PCOS according to the 2003 Rotterdam Consensus conference criteria
  • •3\.One or more of the following dermatological manifestations of hyperandrogenism: hirsutism, androgenetic alopecia, acne

Exclusion Criteria

  • •1\. Smoking, alcoholism, drug addiction
  • •2\. Current pregnancy.
  • •3\. Current or previous use (up to three months before the study) of oral, vaginal, monthly injectable, or transdermal combined hormonal contraceptives
  • •4\. Current or previous use (up to six months before the study) of a long\-lasting hormonal contraceptive method (injectable, implant, or intrauterine device)
  • •5\. Current use of antiandrogens, hypoglycemic drugs, statins
  • •6\. Presence of systemic diseases (diabetes mellitus, cardiovascular disease, autoimmune diseases, liver disease, thyroid disease, or congenital adrenal hyperplasia)
  • •7\. Personal history of arterial or venous thrombosis
  • •8\. Puerperium of 24 weeks or less
  • •9\. Psychiatric illness or on anti\-psychotic drugs
  • •10\. Renal disease

Outcomes

Primary Outcomes

Not specified

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