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Efficacy of Diamel in the Treatment of Polycystic Ovary Syndrome


Phase 3
18 Years
40 Years
Not Enrolling
Female
Polycystic Ovary Syndrome

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Trial Information

Efficacy of Diamel in the Treatment of Polycystic Ovary Syndrome


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Normalization of blood concentrations of androgens at week 24

Outcome Time Frame:

24 weeks

Safety Issue:

Yes

Principal Investigator

Mercedes Hernandez, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

"Ramón González Coro" Gynecologic and Obstetric Hospital

Authority:

Cuba: Institutional Review Board

Study ID:

CAT-0917-CU

NCT ID:

NCT01051024

Start Date:

November 2009

Completion Date:

April 2011

Related Keywords:

  • Polycystic Ovary Syndrome
  • Dietary supplement
  • Diamel
  • Polycystic Ovary Syndrome
  • Female Infertility
  • Polycystic Ovary Syndrome

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