NCT05981742

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Al-Rasheed University College · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
DRUG	Metformin Hydrochloride 500 MG	Brand name: (Glucophage) Tablets per oral / Twice daily / 90 days duration
DRUG	Cabergoline 0.5 MG	Brand name: (Pergoline) Tablets per oral / single dose per week / 90 days duration
DRUG	Metformin Hydrochloride 500 MG + 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

Timeline

• Start date: 2022-09-21
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2023-08-08
• Last updated: 2023-08-08

Locations

1 site across 1 country: Iraq