Polycystic Ovary Syndrome
Conditions
Keywords
Dietary supplement, Diamel, Polycystic Ovary Syndrome, Female Infertility
Brief 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.
Interventions
DIETARY_SUPPLEMENTDiamel
Two Diamel tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks.
DIETARY_SUPPLEMENTPlacebo
Two Placebo tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks.
Sponsors
Catalysis SL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Normalization of blood concentrations of glucose at week 24 | 24 weeks |
| Regularization of the menstrual cycle 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 |
| 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 |
Countries
Cuba
Outcome results
None listed