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

January 15, 2010
May 2, 2012
November 2009
April 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01051024 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Diamel in the Treatment of Polycystic Ovary Syndrome
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Polycystic Ovary Syndrome
  • 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.
  • Experimental: A
    Diamel
    Intervention: Dietary Supplement: Diamel
  • Placebo Comparator: B
    Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Cuba
 
NCT01051024
CAT-0917-CU
Yes
Catalysis SL
Catalysis SL
Not Provided
Principal Investigator: Mercedes Hernandez, MD "Ramón González Coro" Gynecologic and Obstetric Hospital
Catalysis SL
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP