Vitamin D deficient female subjects diagnosed with PCOS MedDRA version: 19.0 Level: PT Classification code 10047626 Term: Vitamin D deficiency System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Pharma Patent Kft
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female subject age >18 years at the time of informed consent. 2. Clinical and/or biochemical hyperandrogenism and the proven PCOS by the “Rotterdam” criteria, (ovarian dysfunction, oligo- and/or anovulation, and the morphology of polycystic ovaries on ultrasound images when other etiologies are excluded) 3. 25(OH)D levels =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Has been exposed to any investigational agent within 3 month of enrolment to the study 2. Sever metabolic disease on endorcrine disease in etiology different from PCOS 3. -Significant obesity (BMI> 36) 4. Any other other signs of lab results that may lead to other etiologies in differentiation 5. Increased serum calcium level results or symptoms of hypercalcemia in last one year 6. Hypercalciuria or kidney stone appearance in last one year 7. Sever kidney diseases (CKD 3 or higher) 8. -Chronic or serious disease, which can significantly influence the absorption, metabolism of vitamin D or Ca 9. Heart failure or angina pectoris, 10. More than 1000 IU vitamin D per day intake or in total >3000 IU per week within 1 month prior to trial (in any forms medication, or nutritional food supplement) 11. The patient is under hormonal therapy for the aim of ovulation stimulation or was involved in within 3 months prior the study 12. Existence or suspected gravidity 13. Any other finding or symptoms which are by the opinion of the Investigator may indicate a potential interference with the safety of participating trial subjects 14. Has a known hypersensitivity to any of the investigational drug or vehicle components. 15. Concomitant medication which is not allowed:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy is consider as reveal of ovarian dysfunction based on progesterone levels and menses diary.;Secondary Objective: - Efficacy and safety of orally administered vitamin D treatment by the changes in 25(OH) D levels. - Changes in Ovarian – morphology based on results of standard TVUS Imaging - All AE detected during treatment and follow-up period compared to placebo group. ;Primary end point(s): Regularity of ovarian function in at least 20% of subjects, detected by changes in progesterone levels and menses diary.;Timepoint(s) of evaluation of this end point: Evaluated on the 12 weeks and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety endpoints: - Registration and identification of adverse events (included clinically significant lab abnormalities), by frequency and comparative analysis of distribution compared to placebo-treated patients - Changes in serum calcium, urinary calcium / creatinine ratio compared to the base and the control group as safety parameters. Efficacy analysis: - Evaluation of treatment of changes in 25 (OH) D blood levels compared between treatment groups - Change of endocrine parameters also of blood glucose and HgbA1c values effected by treatment between the groups and compared to the base, and the evaluation stratified by the 25OHD levels. - Changes in ovarian morphology assessed by TVUS imaging and compared between groups ;Timepoint(s) of evaluation of this end point: Efficacy Evaluated on the 12 weeks and 24 weeks , Safety on the weeks 6, 12 18 and 24. | — |
Countries
Hungary
Contacts
Public ContactIroda-törzskönyvezés
Pharma Patent Kft
Outcome results
None listed