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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 29, 2014