Diamel in the Treatment of Polycystic Ovary Syndrome

May 2, 2012 updated by: Catalysis SL

Efficacy of Diamel in the Treatment of Polycystic Ovary Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cuba
    • Havana
      • Havana City, Havana, Cuba, 10400
        • "Ramón González Coro" Gynecologic and Obstetric Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Two of the following criteria:

    • Oligo or Anovulation
    • Polycystic Ovary diagnosed by ultrasound technique
    • Clinical signs of Hyperandrogenism
  • Signed informed consent

Exclusion Criteria:

  • Personal history of other causes of hyperandrogenism: Hyperprolactinemia, suprarenal tumors, ovary tumors, suprarenal hyperplasia, hypercortisolism.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: B
Placebo
Dietary supplement: Placebo
Two Placebo tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks.
Experimental: A
Diamel
Dietary supplement: Diamel
Two Diamel tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Normalization of blood concentrations of androgens at week 24
Time Frame: 24 weeks
24 weeks
Normalization of blood concentrations prolactin at week 24
Time Frame: 24 weeks
24 weeks
Normalization of blood concentrations of estrogens at week 24
Time Frame: 24 weeks
24 weeks
Normalization of blood concentrations of FSH at week 24
Time Frame: 24 weeks
24 weeks
Normalization of blood concentrations of LH at week 24
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Regularization of the menstrual cycle at week 24.
Time Frame: 24 weeks
24 weeks
Reappearance of ovulatory cycles at week 24
Time Frame: 24 weeks
24 weeks
Normalization of blood concentrations of insulin at week 24
Time Frame: 24 weeks
24 weeks
Normalization of blood concentrations of cholesterol at week 24
Time Frame: 24 weeks
24 weeks
Normalization of blood concentrations of triglycerides at week 24
Time Frame: 24 weeks
24 weeks
Normalization of blood concentrations of glucose at week 24
Time Frame: 24 weeks
24 weeks
Improvement of clinical signs associated with polycystic ovary syndrome: acne, hirsutism, abdominal obesity, and blood pressure at week 24.
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalysis SL

Investigators

  • Principal Investigator: Mercedes Hernandez, MD, "Ramón González Coro" Gynecologic and Obstetric Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

January 15, 2010

First Submitted That Met QC Criteria

January 15, 2010

First Posted (Estimate)

January 18, 2010

Study Record Updates

Last Update Posted (Estimate)

May 4, 2012

Last Update Submitted That Met QC Criteria

May 2, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAT-0917-CU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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