Diamel in the Treatment of Polycystic Ovary Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Diamel in the Treatment of Polycystic Ovary Syndrome

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Dietary Supplement: Diamel
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Diamel | Dietary Supplement: Diamel<br>* Two Diamel tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks.<br>|
| Placebo Comparator: B<br>Placebo | Dietary Supplement: Placebo<br>* Two Placebo tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary supplement, Diamel, Polycystic Ovary Syndrome, Female Infertility