Diamel in the Treatment of Polycystic Ovary Syndrome

Phase 3

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Dietary Supplement: Diamel; Dietary Supplement: Placebo

• Registration Number: NCT01051024
• Lead Sponsor: Catalysis SL

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-01-15
• Study First Submitted QC: 2010-01-15
• Study First Posted: 2010-01-18
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-02
• Last Update Posted: 2012-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Diamel	Diamel
B	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Normalization of blood concentrations of androgens at week 24	24 weeks
Normalization of blood concentrations prolactin at week 24	24 weeks
Normalization of blood concentrations of estrogens at week 24	24 weeks
Normalization of blood concentrations of FSH at week 24	24 weeks
Normalization of blood concentrations of LH at week 24	24 weeks

Secondary Outcome Measures

Name	Time	Method
Regularization of the menstrual cycle at week 24.	24 weeks
Reappearance of ovulatory cycles at week 24	24 weeks
Normalization of blood concentrations of insulin at week 24	24 weeks
Normalization of blood concentrations of cholesterol at week 24	24 weeks
Normalization of blood concentrations of triglycerides at week 24	24 weeks
Normalization of blood concentrations of glucose at week 24	24 weeks
Improvement of clinical signs associated with polycystic ovary syndrome: acne, hirsutism, abdominal obesity, and blood pressure at week 24.	24 weeks

Trial Locations

Locations (1)

"Ramón González Coro" Gynecologic and Obstetric Hospital; 🇨🇺 Havana City, Havana, Cuba