Diamel in the Treatment of Polycystic Ovary Syndrome - Full Text View

Sponsor:	Catalysis SL
Information provided by (Responsible Party):	Catalysis SL
ClinicalTrials.gov Identifier:	NCT01051024

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:

MedlinePlus related topics: Diabetes Medicines Dietary Supplements Polycystic Ovary Syndrome

U.S. FDA Resources

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 May 24, 2012