A Phase 3 interventional study of Diamel and Placebo in Polycystic Ovary Syndrome, sponsored by Catalysis SL. Completed at 1 site in Cuba. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2012-05-04.
Sponsored by Catalysis SL · Phase 3, Interventional, and Treatment
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.
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's enrollment of 110 is above the median of 70 across 697 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Catalysis SL is the lead sponsor of 53 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Two of the following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diamel
Dietary Supplement: Diamel
Placebo
Dietary Supplement: Placebo
Two Diamel tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks.
Two Placebo tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks.
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
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.
Time frame: 24 weeks
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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