Diamel in the Treatment of Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:

Efficacy of Diamel in the Treatment of Polycystic Ovary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01051024
• Other study ID #: CAT-0917-CU
• Status: Completed
• Phase: Phase 3
• First received: January 15, 2010
• Last updated: May 2, 2012
• Start date: November 2009
• Est. completion date: April 2011

Study information

• Verified date: May 2012
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cuba: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Diamel
Two Diamel tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks.
• Placebo
Two Placebo tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks.

Locations

Country	Name	City	State
Cuba	"Ramón González Coro" Gynecologic and Obstetric Hospital	Havana City	Havana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normalization of blood concentrations of androgens at week 24		24 weeks	Yes
Primary	Normalization of blood concentrations prolactin at week 24		24 weeks	Yes
Primary	Normalization of blood concentrations of estrogens at week 24		24 weeks	Yes
Primary	Normalization of blood concentrations of FSH at week 24		24 weeks	Yes
Primary	Normalization of blood concentrations of LH at week 24		24 weeks	Yes
Secondary	Regularization of the menstrual cycle at week 24.		24 weeks	No
Secondary	Reappearance of ovulatory cycles at week 24		24 weeks	No
Secondary	Normalization of blood concentrations of insulin at week 24		24 weeks	No
Secondary	Normalization of blood concentrations of cholesterol at week 24		24 weeks	No
Secondary	Normalization of blood concentrations of triglycerides at week 24		24 weeks	No
Secondary	Normalization of blood concentrations of glucose at week 24		24 weeks	No
Secondary	Improvement of clinical signs associated with polycystic ovary syndrome: acne, hirsutism, abdominal obesity, and blood pressure at week 24.		24 weeks	No