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The goal of this interventional Randomized clinical is to compare the effect of Metformin alone, Cabergoline alone and Metformin and Cabergoline in combination in a sample of Iraqi female patients with polycystic ovary syndrome. The main questions to answer are:
Participants will be separated into two groups:
Researchers will compare Group 1 (M), Group 2 (D), Group 3 (MD) to observe the effect of the tested treatment regimens on Body Mass Index, Hormonal status, uterine artery resistive index, and some inflammatory markers that are IL-18, Anti-GAD Antibody and GnRH Antibody.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (M) | Active Comparator | 25 Patients administered Metformin (Glucophage) Tablets of 500 mg per oral twice daily for 90 days duration. |
|
| Group 2 (D) | Active Comparator | 25 Patients administered Cabergoline (Pergoline) Tablets of 0.5 mg dose per oral once weekly for 90 days duration. |
|
| Group 3 (MD) | Active Comparator | 25 Patients administered Metformin (Glucophage) Tablets of 500 mg per oral twice daily and Cabergoline (Pergoline) Tablets of 0.5 mg dose per oral once weekly for 90 days duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin Hydrochloride 500 MG | Drug | Brand name: (Glucophage) Tablets per oral / Twice daily / 90 days duration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) | Measured in Kg/m² as a part of hormone status changes analysis | at Baseline, and after 90 days |
| Serum Anti-Müllerian hormone (AMH) | Measured in ng/mL as a part of hormone status changes analysis | at Baseline, and after 90 days |
| Serum Testosterone | Measured in ng/mL as a part of hormone status changes analysis | at Baseline, and after 90 days |
| Serum Luteinizing hormone (LH) | Measured in mIU/mL as a part of hormone status changes analysis | at Baseline, and after 90 days |
| Serum Follicular Stimulating Hormone (FSH) | Measured in mIU/mL as a part of hormone status changes analysis | at Baseline, and after 90 days |
| Serum Prolactin (PRL) | Measured in ng/mL as a part of hormone status changes analysis | at Baseline, and after 90 days |
| Mean number of dominant follicles (DF) | Calculated by ultrasonography as a part of the ultrasonic analysis | at Baseline, and after 90 days |
| Mean Resistive Index (RI) | Calculated by ultrasonography as a part of the ultrasonic analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Inas Naser Hamad, B.Sc. Pharmacy | University of Al-Qadisiyah | Principal Investigator |
| Sinaa Abdul Amir Kadhim, Ph.D Pharmacology | University of Al-Qadisiyah | Study Director |
| Hayder Adnan Fawzi, Ph.D Clinical Pharmacy | Al-Mustafa University College | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternity and Pediatric Teaching Hospital | Al Qādisīyah | Al-Qādisiyyah Governorate | 58001 | Iraq |
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| Cabergoline 0.5 MG | Drug | Brand name: (Pergoline) Tablets per oral / single dose per week / 90 days duration |
|
| Metformin Hydrochloride 500 MG + Cabergoline 0.5 MG | Drug | Metformin Brand name: (Glucophage) Tablets per oral / Twice daily / 90 days duration Cabergoline Brand name: (Pergoline) Tablets per oral / single dose per week / 90 days duration |
|
| at Baseline, and after 90 days |
| Serum Anti-GAD antibody | Measured in ng/mL as a part of inflammatory markers analysis | at Baseline, and after 90 days |
| Serum Anti-GnRH antibody | Measured in pg/mL as a part of inflammatory markers analysis | at Baseline, and after 90 days |
| Serum IL-18 Level | Measured in pg/mL as a part of inflammatory markers analysis | at Baseline, and after 90 days |
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | 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 |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D000077465 | Cabergoline |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D004873 | Ergolines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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