Diamel in the Treatment of Polycystic Ovary Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Catalysis SL
ClinicalTrials.gov Identifier:
NCT01051024
First received: January 15, 2010
Last updated: May 2, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Polycystic Ovary Syndrome
Dietary Supplement: Diamel
Dietary Supplement: Placebo
Phase 3

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
Official Title: Efficacy of Diamel in the Treatment of Polycystic Ovary Syndrome

Resource links provided by NLM:


Further study details as provided by Catalysis SL:

Primary Outcome Measures:
  • Normalization of blood concentrations of androgens at week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Normalization of blood concentrations prolactin at week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Normalization of blood concentrations of estrogens at week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Normalization of blood concentrations of FSH at week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Normalization of blood concentrations of LH at week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Regularization of the menstrual cycle at week 24. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Reappearance of ovulatory cycles at week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Normalization of blood concentrations of insulin at week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Normalization of blood concentrations of cholesterol at week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Normalization of blood concentrations of triglycerides at week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Normalization of blood concentrations of glucose at week 24 [ Time Frame: 24 weeks ] [ Designated as 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 ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: November 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01051024

Locations
Cuba
"Ramón González Coro" Gynecologic and Obstetric Hospital
Havana City, Havana, Cuba, 10400
Sponsors and Collaborators
Catalysis SL
Investigators
Principal Investigator: Mercedes Hernandez, MD "Ramón González Coro" Gynecologic and Obstetric Hospital
  More Information

No publications provided

Responsible Party: Catalysis SL
ClinicalTrials.gov Identifier: NCT01051024     History of Changes
Other Study ID Numbers: CAT-0917-CU
Study First Received: January 15, 2010
Last Updated: May 2, 2012
Health Authority: Cuba: Institutional Review Board

Keywords provided by Catalysis SL:
Dietary supplement
Diamel
Polycystic Ovary Syndrome
Female Infertility

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 22, 2014