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Brief Title: Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS
Official Title: Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS
Study ID: NCT05981742
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Maternity and Pediatric Teaching Hospital, Al Qādisīyah, Al-Qādisiyyah Governorate, Iraq
Name: Inas Naser Hamad, B.Sc. Pharmacy
Affiliation: University of Al-Qadisiyah
Role: PRINCIPAL_INVESTIGATOR
Name: Sinaa Abdul Amir Kadhim, Ph.D Pharmacology
Affiliation: University of Al-Qadisiyah
Role: STUDY_DIRECTOR
Name: Hayder Adnan Fawzi, Ph.D Clinical Pharmacy
Affiliation: Al-Mustafa University College
Role: STUDY_CHAIR