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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Diamel |
|
| B | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diamel | Dietary Supplement | Two Diamel tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Two of the following criteria:
Signed informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mercedes Hernandez, MD | "Ramón González Coro" Gynecologic and Obstetric Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Ramón González Coro" Gynecologic and Obstetric Hospital | Havana | La Habana | 10400 | Cuba |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| Placebo | Dietary Supplement | Two Placebo tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks. |
|
| 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 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D007246 | Infertility |