Diamel in the Treatment of Polycystic Ovary Syndrome

Verified by: Catalysis SL, March 2011
First Received: January 15, 2010 | Last Updated: March 6, 2011 | Phase: Phase 3 | Start Date: November 2009
Overall Status: Active, not recruiting | Estimated Enrollment: 110
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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...

Brief Summary

Official Title: “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 Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: April 2011

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: A
    • Diamel
  • Placebo Comparator: B
    • Placebo

Outcome Measures for this Clinical Trial

Primary Measures

  • Normalization of blood concentrations of androgens at week 24
    • Time Frame: 24 weeks
      Safety Issue?: Yes
  • Normalization of blood concentrations prolactin at week 24
    • Time Frame: 24 weeks
      Safety Issue?: Yes
  • Normalization of blood concentrations of estrogens at week 24
    • Time Frame: 24 weeks
      Safety Issue?: Yes
  • Normalization of blood concentrations of FSH at week 24
    • Time Frame: 24 weeks
      Safety Issue?: Yes
  • Normalization of blood concentrations of LH at week 24
    • Time Frame: 24 weeks
      Safety Issue?: Yes

Secondary Measures

  • Regularization of the menstrual cycle at week 24.
    • Time Frame: 24 weeks
      Safety Issue?: No
  • Reappearance of ovulatory cycles at week 24
    • Time Frame: 24 weeks
      Safety Issue?: No
  • Normalization of blood concentrations of insulin at week 24
    • Time Frame: 24 weeks
      Safety Issue?: No
  • Normalization of blood concentrations of cholesterol at week 24
    • Time Frame: 24 weeks
      Safety Issue?: No
  • Normalization of blood concentrations of triglycerides at week 24
    • Time Frame: 24 weeks
      Safety Issue?: No
  • Normalization of blood concentrations of glucose at week 24
    • Time Frame: 24 weeks
      Safety Issue?: No
  • Improvement of clinical signs associated with polycystic ovary syndrome: acne, hirsutism, abdominal obesity, and blood pressure at week 24.
    • Time Frame: 24 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Catalysis SL Industry

Overall Clinical Trial Officials and Contacts

Josefina López Menéndez, MD Principal Investigator "Ramón González Coro" Gynecologic and Obstetric Hospital  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01051024

Study ID Number: CAT-0917-CU

ClinicalTrials.gov Identifier: NCT01051024

Health Authority: Cuba: Institutional Review Board

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01051024