Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003353-22 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Jordan University of Science and Technology | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective double-blind, randomized, parallel-group, placebo-controlled trial designed to examine the effect of supplementation with 50,000 IU vitamin D3 for 3 months on Polycystic Ovary Syndrome (PCOS) prognosis, serum 25-Hydroxy Vitamin D (25(OH)D) level, serum chromium level, insulin resistance, and Body Mass Index (BMI), in 60 overweight Jordanian female patients diagnosed with PCOS and with hypovitaminosis D.
This study is designed to assess the safety and efficacy of 50,000 IU vitamin D supplementation once weekly for 3 months on improvement in PCOS prognosis and improvement in serum 25(OH)D levels in 60 overweight Jordanian females (defined as having a BMI 25-30kg/m2), diagnosed with PCOS (based on Rotterdam criteria), and with hypovitaminosis D (defined as a serum 25(OH)D level < 20 ng/mL), compared with placebo.
Evaluation of the safety and efficacy of the dosing regimen will be conducted over 6 study visits during which clinical and biochemical signs of PCOS as well as serum 25(OH)D level, serum chromium level, insulin resistance, and BMI will be evaluated.
The measurements will be collected as follows : day (-7) during screening , Day (0) base line measurements , Day (30) , Day(60), Day (90), day (104).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin D3 (Biodal 50,000 IU) | Active Comparator | 50,000 IU Vitamin D3 tablet given orally once weekly for 3 months |
|
| placebo | Placebo Comparator | Placebo tablet given orally once weekly for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 50,000 IU vitamin D3 | Drug | Film-coated tablet Biodal 50,000 IU containing cholecalciferol 50,000 IU |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ultrasound Examination of Number of Follicles and Ovarian Volume | Evaluation of the efficacy of the dosing regimen as per the approved Summery of Product Characteristics (SmPC) (50,000 IU vitamin D3 once weekly for 3 months) on improvement in PCOS prognosis clinically using ultrasound examination. In this measure the reported results were the finding of the ultrasound examination after the course of the treatment /intervention as per the study protocol and reporting the numbers of patients with normal ovaries, One normal ovary and the other is polycystic or both ovaries are poly-cystic. An improvement in PCOS prognosis clinically by ultrasound examination is defined by:
| 3 months |
| Menstrual Regularity | Evaluation of the efficacy of the dosing regimen as per the approved SmPC (50,000 IU vitamin D3 once weekly for 3 months) on improvement in PCOS prognosis by assessment of menstrual regularity An improvement in PCOS prognosis by assessment of menstrual regularity is measured through improving progesterone level > 4 ng/mL. One of the clinical signs of improving PCOS prognosis is menstrual cycle regularity. In this measure ,the reported results consist of the number of volunteers/patients in each arm either with regular menstrual cycle or irregular menstrual cycle after completing the course of the treatment/ intervention as per the study protocol. The results will be statistically analyzed using paired student t-test and 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated. | 3 months |
| Hirsutism Score | The scale ranges between 0 and 36, where A score of 8 or higher was considered as androgen excess (Ferriman and Gallwey, 1961).Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on PCOS prognosis by evaluating Hirsutism Score.Hirsutism score was assessed using self-administrated Ferriman-Gallwey scoring system (Ferriman and Gallwey, 1961). Each participant answered the hirsutism test with the help of a trained nurse who was working in the same clinic. The score of each body site may range between 0 (no excessive terminal hair growth) to 4 (extensive terminal hair growth). In this measure , the hirsutism score were reported in each are after completing the course of treatment/ intervention as per the study protocol. after which, the means were compared for statistical significance between the two groups / arms. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum 25-Hydroxy Vitamin D3 Level | Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on increase the level of serum 25(OH)D > 20 ng/ml by measuring of the serum 25(OH)D levels on 104 of the study period after 3 months treatment . In this measure , Serum 25-Hydroxy Vitamin D3 leveln in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| ALA M ABU RUQAA, MSC PHARM | HAYAT PHARMACEUTICAL INDUSTRIES CO. PLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Abdullah University Hospital | Irbid | Irbid Governorate | 22110 | Jordan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33010974 | Derived | Al-Bayyari N, Al-Domi H, Zayed F, Hailat R, Eaton A. Androgens and hirsutism score of overweight women with polycystic ovary syndrome improved after vitamin D treatment: A randomized placebo controlled clinical trial. Clin Nutr. 2021 Mar;40(3):870-878. doi: 10.1016/j.clnu.2020.09.024. Epub 2020 Sep 24. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Approximately 120 women will be assessed for eligibility clinically, anthropometrically, dietary and biochemically.
Women diagnosed with PCOS and vitamin D deficiency will be randomly divided into 2 groups
Random sample of women attending outpatient obstetrics and gynecology clinics in King Abdullah Hospital / Jordan University of Science and Technology
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D3 (Biodal 50,000IU) | 50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route 50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months |
| FG001 | Placebo | placebo coated tablet by oral route placebo: placebo coated tablet by oral route |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Number of participants in each arm had been randomly allocated.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D3 (Biodal 50,000IU) | 50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route 50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months |
| BG001 | Placebo (Biodal 50,000IU Placebo) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ultrasound Examination of Number of Follicles and Ovarian Volume | Evaluation of the efficacy of the dosing regimen as per the approved Summery of Product Characteristics (SmPC) (50,000 IU vitamin D3 once weekly for 3 months) on improvement in PCOS prognosis clinically using ultrasound examination. In this measure the reported results were the finding of the ultrasound examination after the course of the treatment /intervention as per the study protocol and reporting the numbers of patients with normal ovaries, One normal ovary and the other is polycystic or both ovaries are poly-cystic. An improvement in PCOS prognosis clinically by ultrasound examination is defined by:
| The participants in the treatment and placebo groups will be classified into two categories of prognosis (improved and not improved) and will be analyzed using Chi-square test, if Chi-square is higher than 3.84 (df=1) it will be statistically significant (p-value\ | Posted | Number | participants | 3 months |
|
Baseline, 3 months
Vitamin D supplementation for vitamin D deficient (<20 ng/ml) women with 50,000 IU/week for 12 weeks did not lead to any side effects.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin D3 (Biodal 50,000IU) | 50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route 50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| In-compliance , Withdral | Social circumstances | Non-systematic Assessment | One Volunteer was dropped out due to in-compliance / Not responding to phone call. One Volunteer had withdrawn due to long term travel outside the country after starting the study |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DR. ALA' ABU RUQA'A | Hayat Pharmaceutical industries | 00962 6 4162607 | 225 | tbd@hayatpharma.com |
Not provided
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D014808 | Vitamin D Deficiency |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
Not provided
Not provided
| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo film-coated tablet of Biodal 50,000 IU |
|
|
| 3 months |
| Serum Progesterone Level | The results below show the Serum Progesterone level after treatment in each arm after completing the course of the treatment / intervention as per the study protocol.after which, the means were compared for statistical significance between the two groups / arms. After which, the means were compared for statistical significance between the two groups / arms. The evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on PCOS Prognosis by measuring Change in Serum Progesterone level. One of the clinical signs of improving PCOS prognosis is the change in progesterone level. the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated. | 3 months |
| Total Testosterone Level | Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on PCOS Prognosis by measuring Change in Total Testosterone level before and after the treatment. In this measure , the Total Testosterone levels in each arm were reported after completing the course of the treatment / intervention as per the study protocol. One of the clinical signs of improving PCOS prognosis is the change in testosterone level. After which, the means were compared for statistical significance between the two groups / arms. the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated. | 3 months |
| Free Androgen Index | Free Androgen Index is calculated as the ratio of total testosterone to sex hormone binding globulin (SHBG). In this measure , the Free Androgen Index in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms. Improvement assessment of PCOS Prognosis by evaluating the change in Free Androgen Index. One of the clinical signs of improving PCOS prognosis is the change in FAI. the results will be statistically analyzed using Wilcoxon (Mann- Whitney) method at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated. | 3 months |
| Sex Hormone Binding Globulin Concentration | Evaluation of Biodal 50,000 IU on improvement of PCOS Prognosis by comparing the Sex Hormone Binding Globulin concentrations in both groups/arms. One of the clinical signs of improving PCOS prognosis is the change in the Sex Hormone Binding Globulin Concentration. In this measure , the Sex Hormone Binding Globulin Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms. The results will be statistically analyzed using Wilcoxon (Mann-Whiteny) method at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated. | 3 months |
| 3 months |
| Serum Chromium Concentration | Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on improving serum chromium level to be > 0.05 and < 0.5 ppm. which will be assessed by measuring serum chromium level before and after supplementation of Vitamin D3. In this measure , Serum chromium Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms. One of the clinical signs of improving PCOS prognosis is the improvement in serum chromium level . the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated. | 3 months |
| Serum Glucose Concentration in Oral Glucose Tolerance Test 1st hr After Treatment | Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on reduction of insulin resistance and improving insulin sensitivity measuring Oral Glucose Tolerance Test 1st hr after the treatment and to compare with same at baseline point within the time frame. In this measure , Serum Glucose Concentration in Oral Glucose Tolerance test in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms. One of the clinical signs of improving PCOS prognosis is the improvement in insulin resistance by evaluating the results of Oral Glucose Tolerance Test 1st hr . the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI). | 3 months |
| Body Mass Index | Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on reduction of body mass index to be <25-30 kg/m^2. Evaluation of the Effectiveness of the dose (50,000IU) and the dose regimen as per the approved SmPC on reduction in Body Mass Index before and after the treatment. After which, the means were compared for statistical significance between the two groups / arms. In this measure , Body Mass Index in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). | 3 months |
| Serum Parathyroid Hormone Concentration | Evaluation of the Safety of the Dose and the Dose Regimen as Per the SmPC by measuring the change in the level of serum Serum Parathyroid Hormone (PTH) Concentration before and after the treatment and/or reporting any adverse events through the trial period. In this measure , Serum Parathyroid Hormone Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms. | 3 months |
| Serum Calcium Concentration | Evaluation of the safety of the dose and the dose regimen as per the SmPC by measuring the change in the level of serum Calcium before and after the treatment and/or reporting it as adverse. event through the trial period. as the increase of Serum calcium concentration above the normal level is considered as adverse event for the intervention dose regimen of this study for the purpose of evaluating the safety. In this measure , Serum Calcium Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms. | 3 months |
| Serum Phosphorous Concentration | Evaluation of the safety of the dose and the dose regimen as per the SmPC by measuring the change in the level of serum PO4 Concentration before and after the treatment and/or reporting as adverse event through the trial period.as the increase of Serum phosphoruse concentration above the normal level is considered as adverse event for the intervention dose regimen of this study for the purpose of evaluating the safety. In this measure , Serum Phosphorous Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms. | 3 months |
| Serum C-Reactive Protien Concentration | Evaluation of the Efficacy of the Dose (50,000IU) and the Dose Regimen on inflammation by measuring reduction of the serum concentration of C-Reactive Protein before and after the treatment. In this measure , Serum C-Reactive Protien Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms. | 3 months |
Placebo (Biodal 50,000IU Placebo tablets) coated tablets by oral route
Placebo: 50,000IU Vitamin D3 placebo (Biodal 50,000IU placebo) once weekly for 3 months
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Ultrasound Examination | Number | participants |
|
| Hirsutism Score | The scale ranges between 0 and 36, where A score of 8 or higher was considered as androgen excess (Ferriman and Gallwey, 1961). Hirsutism score was assessed using self-administrated Ferriman-Gallwey scoring system (Ferriman and Gallwey, 1961). Each participant answered the hirsutism test with the help of a trained nurse who was working in the same clinic. The score of each body site may range between 0 (no excessive terminal hair growth) to 4 (extensive terminal hair growth). | Mean | Standard Deviation | units on a scale |
|
| 25(OH)D Serum Level | Mean | Standard Deviation | ng/ml |
|
| Progesterone Serum Level | Mean | Standard Deviation | nmol/L |
|
| Total Testosteron Serum Level | Mean | Standard Deviation | nmol/L |
|
| Chromium Serum Level | Mean | Standard Deviation | ppm |
|
| Calcium Serum Level | Mean | Standard Deviation | mmol/L |
|
| Phosphorus Serum Level | Mean | Standard Deviation | nmol/L |
|
| Parathyroide Hormon Serum Level | Mean | Standard Deviation | Pg/ml |
|
| Lipid Profile | Mean | Standard Deviation | mmol/L |
|
| TC / HDL-C Ratio | This indicate the Total Cholesterol to High Density Lipoprotien ratio. An optimal ratio is between 3.5-to-1. A higher ratio means a higher risk of heart disease. | Mean | Standard Deviation | Ratio |
|
| Fasting Insulin Serum Level | Mean | Standard Deviation | uU/ml |
|
| Fasting Blood Sugar Serum Level | Mean | Standard Deviation | mmol/L |
|
| C-Reactive Protien Serum Level | Mean | Standard Deviation | mg/L |
|
| Oral Glucose Tolerance Test (1st Hour) | Mean | Standard Deviation | mmol/L |
|
| Sex Hormon Binding Globulin | Mean | Standard Deviation | nmol/L |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Menstrual Cycle Regularity | Number | participants |
|
| OG000 | Vitamin D3 (Biodal 50,000IU) | 50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route 50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months |
| OG001 | Placebo | placebo coated tablet by oral route placebo: placebo coated tablet by oral route |
|
|
|
| Secondary | Serum 25-Hydroxy Vitamin D3 Level | Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on increase the level of serum 25(OH)D > 20 ng/ml by measuring of the serum 25(OH)D levels on 104 of the study period after 3 months treatment . In this measure , Serum 25-Hydroxy Vitamin D3 leveln in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms. | Posted | Mean | Standard Error | ng/ml | 3 months |
|
|
|
|
| Secondary | Serum Chromium Concentration | Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on improving serum chromium level to be > 0.05 and < 0.5 ppm. which will be assessed by measuring serum chromium level before and after supplementation of Vitamin D3. In this measure , Serum chromium Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms. One of the clinical signs of improving PCOS prognosis is the improvement in serum chromium level . the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated. | Posted | Mean | Standard Error | ppm | 3 months |
|
|
|
|
| Secondary | Serum Glucose Concentration in Oral Glucose Tolerance Test 1st hr After Treatment | Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on reduction of insulin resistance and improving insulin sensitivity measuring Oral Glucose Tolerance Test 1st hr after the treatment and to compare with same at baseline point within the time frame. In this measure , Serum Glucose Concentration in Oral Glucose Tolerance test in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms. One of the clinical signs of improving PCOS prognosis is the improvement in insulin resistance by evaluating the results of Oral Glucose Tolerance Test 1st hr . the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI). | Posted | Mean | Standard Error | mmol/L | 3 months |
|
|
|
|
| Secondary | Body Mass Index | Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on reduction of body mass index to be <25-30 kg/m^2. Evaluation of the Effectiveness of the dose (50,000IU) and the dose regimen as per the approved SmPC on reduction in Body Mass Index before and after the treatment. After which, the means were compared for statistical significance between the two groups / arms. In this measure , Body Mass Index in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). | Posted | Mean | Standard Error | kg/m^2 | 3 months |
|
|
|
|
| Secondary | Serum Parathyroid Hormone Concentration | Evaluation of the Safety of the Dose and the Dose Regimen as Per the SmPC by measuring the change in the level of serum Serum Parathyroid Hormone (PTH) Concentration before and after the treatment and/or reporting any adverse events through the trial period. In this measure , Serum Parathyroid Hormone Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms. | Posted | Mean | Standard Error | Pg/ml | 3 months |
|
|
|
|
| Primary | Menstrual Regularity | Evaluation of the efficacy of the dosing regimen as per the approved SmPC (50,000 IU vitamin D3 once weekly for 3 months) on improvement in PCOS prognosis by assessment of menstrual regularity An improvement in PCOS prognosis by assessment of menstrual regularity is measured through improving progesterone level > 4 ng/mL. One of the clinical signs of improving PCOS prognosis is menstrual cycle regularity. In this measure ,the reported results consist of the number of volunteers/patients in each arm either with regular menstrual cycle or irregular menstrual cycle after completing the course of the treatment/ intervention as per the study protocol. The results will be statistically analyzed using paired student t-test and 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated. | Posted | Number | participants | 3 months |
|
|
|
|
| Secondary | Serum Calcium Concentration | Evaluation of the safety of the dose and the dose regimen as per the SmPC by measuring the change in the level of serum Calcium before and after the treatment and/or reporting it as adverse. event through the trial period. as the increase of Serum calcium concentration above the normal level is considered as adverse event for the intervention dose regimen of this study for the purpose of evaluating the safety. In this measure , Serum Calcium Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms. | Posted | Mean | Standard Error | mmol/L | 3 months |
|
|
|
|
| Secondary | Serum Phosphorous Concentration | Evaluation of the safety of the dose and the dose regimen as per the SmPC by measuring the change in the level of serum PO4 Concentration before and after the treatment and/or reporting as adverse event through the trial period.as the increase of Serum phosphoruse concentration above the normal level is considered as adverse event for the intervention dose regimen of this study for the purpose of evaluating the safety. In this measure , Serum Phosphorous Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms. | Posted | Mean | Standard Error | mmol/L | 3 months |
|
|
|
|
| Primary | Hirsutism Score | The scale ranges between 0 and 36, where A score of 8 or higher was considered as androgen excess (Ferriman and Gallwey, 1961).Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on PCOS prognosis by evaluating Hirsutism Score.Hirsutism score was assessed using self-administrated Ferriman-Gallwey scoring system (Ferriman and Gallwey, 1961). Each participant answered the hirsutism test with the help of a trained nurse who was working in the same clinic. The score of each body site may range between 0 (no excessive terminal hair growth) to 4 (extensive terminal hair growth). In this measure , the hirsutism score were reported in each are after completing the course of treatment/ intervention as per the study protocol. after which, the means were compared for statistical significance between the two groups / arms. | Posted | Mean | Standard Error | units on a scale | 3 months |
|
|
|
|
| Secondary | Serum C-Reactive Protien Concentration | Evaluation of the Efficacy of the Dose (50,000IU) and the Dose Regimen on inflammation by measuring reduction of the serum concentration of C-Reactive Protein before and after the treatment. In this measure , Serum C-Reactive Protien Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms. | Posted | Mean | Standard Error | mg/L | 3 months |
|
|
|
|
| Primary | Serum Progesterone Level | The results below show the Serum Progesterone level after treatment in each arm after completing the course of the treatment / intervention as per the study protocol.after which, the means were compared for statistical significance between the two groups / arms. After which, the means were compared for statistical significance between the two groups / arms. The evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on PCOS Prognosis by measuring Change in Serum Progesterone level. One of the clinical signs of improving PCOS prognosis is the change in progesterone level. the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated. | Posted | Mean | Standard Error | nmol/L | 3 months |
|
|
|
|
| Primary | Total Testosterone Level | Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on PCOS Prognosis by measuring Change in Total Testosterone level before and after the treatment. In this measure , the Total Testosterone levels in each arm were reported after completing the course of the treatment / intervention as per the study protocol. One of the clinical signs of improving PCOS prognosis is the change in testosterone level. After which, the means were compared for statistical significance between the two groups / arms. the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated. | Posted | Mean | Standard Deviation | nmol/L | 3 months |
|
|
|
|
| Primary | Free Androgen Index | Free Androgen Index is calculated as the ratio of total testosterone to sex hormone binding globulin (SHBG). In this measure , the Free Androgen Index in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms. Improvement assessment of PCOS Prognosis by evaluating the change in Free Androgen Index. One of the clinical signs of improving PCOS prognosis is the change in FAI. the results will be statistically analyzed using Wilcoxon (Mann- Whitney) method at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated. | Posted | Mean | Standard Deviation | Ratio | 3 months |
|
|
|
|
| Primary | Sex Hormone Binding Globulin Concentration | Evaluation of Biodal 50,000 IU on improvement of PCOS Prognosis by comparing the Sex Hormone Binding Globulin concentrations in both groups/arms. One of the clinical signs of improving PCOS prognosis is the change in the Sex Hormone Binding Globulin Concentration. In this measure , the Sex Hormone Binding Globulin Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms. The results will be statistically analyzed using Wilcoxon (Mann-Whiteny) method at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated. | Posted | Mean | Standard Deviation | nmol/L | 3 months |
|
|
|
|
| 0 |
| 30 |
| 1 |
| 30 |
| EG001 | Placebo | placebo coated tablet by oral route placebo: placebo coated tablet by oral route | 0 | 30 | 1 | 30 |
|
Not provided
Not provided
| 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 |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |