Diamel in the Treatment of Polycystic Ovary Syndrome

Catalysis SL110 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

110

Conditions

Polycystic Ovary Syndrome

Interventions

DiamelDIETARY_SUPPLEMENT

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

PlaceboDIETARY_SUPPLEMENT

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

"Ramón González Coro" Gynecologic and Obstetric Hospital

Havana, La Habana, Cuba

Outcomes

Primary Outcomes

Normalization of blood concentrations of androgens at week 24

Time frame: 24 weeks

Normalization of blood concentrations prolactin at week 24

Time frame: 24 weeks

Normalization of blood concentrations of estrogens at week 24

Time frame: 24 weeks

Normalization of blood concentrations of FSH at week 24

Time frame: 24 weeks

Normalization of blood concentrations of LH at week 24

Time frame: 24 weeks

Secondary Outcomes

Regularization of the menstrual cycle at week 24.

Time frame: 24 weeks

Reappearance of ovulatory cycles at week 24

Time frame: 24 weeks

Normalization of blood concentrations of insulin at week 24

Time frame: 24 weeks

Normalization of blood concentrations of cholesterol at week 24

Time frame: 24 weeks

Normalization of blood concentrations of triglycerides at week 24

Time frame: 24 weeks

Normalization of blood concentrations of glucose at week 24

Time frame: 24 weeks

Improvement of clinical signs associated with polycystic ovary syndrome: acne, hirsutism, abdominal obesity, and blood pressure at week 24.

Data from ClinicalTrials.gov

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