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
PHASE3
110 participants
INTERVENTIONAL
2009-11-30
2011-04-30
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
QUADRUPLE
Study Groups
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A
Diamel
Diamel
Two Diamel tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks.
B
Placebo
Placebo
Two Placebo tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks.
Interventions
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Diamel
Two Diamel tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks.
Placebo
Two Placebo tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks.
Eligibility Criteria
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Inclusion Criteria
* Oligo or Anovulation
* Polycystic Ovary diagnosed by ultrasound technique
* Clinical signs of Hyperandrogenism
* Signed informed consent
Exclusion Criteria
* Patients under other experimental treatment
* Treatment with ovulation inducers and/or insulin sensitizers within 60 days before treatment
* Treatment with vitamins within 7 days before treatment
* Treatment with dietary supplements within 60 days before treatment
* Non-compensated intercurrent diseases: diabetes mellitus, thyroid disease, hypertension
18 Years
40 Years
FEMALE
No
Sponsors
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Catalysis SL
INDUSTRY
Responsible Party
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Principal Investigators
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Mercedes Hernandez, MD
Role: PRINCIPAL_INVESTIGATOR
"Ramón González Coro" Gynecologic and Obstetric Hospital
Locations
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"Ramón González Coro" Gynecologic and Obstetric Hospital
Havana, La Habana, Cuba
Countries
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Other Identifiers
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CAT-0917-CU
Identifier Type: -
Identifier Source: org_study_id
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