Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS - Trial NCT05981742
Access comprehensive clinical trial information for NCT05981742 through Pure Global AI's free database. This Phase 2 trial is sponsored by Al-Rasheed University College and is currently Completed. The study focuses on Polycystic Ovary Syndrome. Target enrollment is 75 participants.
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Study Focus
Sponsor & Location
Al-Rasheed University College
Timeline & Enrollment
Phase 2
Sep 21, 2022
Mar 31, 2023
Primary Outcome
Body Mass Index (BMI),Serum Anti-Mรผllerian hormone (AMH),Serum Testosterone,Serum Luteinizing hormone (LH),Serum Follicular Stimulating Hormone (FSH),Serum Prolactin (PRL),Mean number of dominant follicles (DF),Mean Resistive Index (RI),Serum Anti-GAD antibody,Serum Anti-GnRH antibody,Serum IL-18 Level
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05981742
Non-Device Trial