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Diamel in the Treatment of Polycystic Ovary Syndrome

NCT01051024 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2012-05-04

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy of Diamel administration in the treatment of Polycystic Ovary Syndrome. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks.

Conditions

  • Polycystic Ovary Syndrome

Interventions

DIETARY_SUPPLEMENT

Placebo

Two Placebo tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks.

DIETARY_SUPPLEMENT

Diamel

Two Diamel tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks.

Sponsors & Collaborators

  • Catalysis SL

    lead INDUSTRY

Principal Investigators

  • Mercedes Hernandez, MD · "Ramón González Coro" Gynecologic and Obstetric Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • Cuba

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01051024 on ClinicalTrials.gov