Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

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Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Endocrine System Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Anti-Dyskinesia Agents

Cardiotonic Agents

Metformin

Hormones

Cabergoline

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Dopamine Agonists

Dopamine Agents

Neurotransmitter Agents

25 Patients administered Metformin (Glucophage) Tablets of 500 mg per oral twice daily for 90 days duration.

25 Patients administered Cabergoline (Pergoline) Tablets of 0.5 mg dose per oral once weekly for 90 days duration.

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.

Brand name: (Glucophage) Tablets per oral / Twice daily / 90 days duration

Metformin Hydrochloride 500 MG

Brand name: (Pergoline) Tablets per oral / single dose per week / 90 days duration

Cabergoline 0.5 MG

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

Metformin Hydrochloride 500 MG + Cabergoline 0.5 MG

Inas Naser Hamad, B.Sc. Pharmacy

Sinaa Abdul Amir Kadhim, Ph.D Pharmacology

Hayder Adnan Fawzi, Ph.D Clinical Pharmacy

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:

1. What are the effects of the tested regimens on Body mass index (BMI)?
2. What are the effects of the tested regimens on hormonal status?
3. What are the effects of the tested regimens on uterine artery resistive index ?
4. What are the effects of the tested regimens on some inflammatory markers?

Participants will be separated into two groups:

1. Group 1 (M): 25 Patients, Received Metformin 500mg per oral twice daily for 90 days duration.
2. Group 2 (D): 25 Patients, Received Dostinex (Pergolin) 0.5 mg per oral (single dose per/week).
3. Group 3 (MD): 25 Pateins, Received metformin 500 mg per oral twice daily for 90 days duration and Dostinex (Pergolin) as 0.5 mg per oral (single dose per/week).

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.

Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS

Measured in Kg/m² as a part of hormone status changes analysis

Measured in ng/mL as a part of hormone status changes analysis

Measured in mIU/mL as a part of hormone status changes analysis

Calculated by ultrasonography as a part of the ultrasonic analysis

Measured in ng/mL as a part of inflammatory markers analysis

Measured in pg/mL as a part of inflammatory markers analysis

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS	NCT05981742	Polycystic Ovar...	Metformin Hydro... Cabergoline 0.5... Metformin Hydro...	18 Years - 40 Years	Al-Rasheed University College
Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS	NCT05981742	Polycystic Ovar...	Metformin Hydro... Cabergoline 0.5... Metformin Hydro...	18 Years - 40 Years	Al-Rasheed University College

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