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

Phase 2

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Cabergoline 0.5 MG; Drug: Metformin Hydrochloride 500 MG; Drug: Metformin Hydrochloride 500 MG + Cabergoline 0.5 MG

• Registration Number: NCT05981742
• Lead Sponsor: Al-Rasheed University College

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

Not available

Study Timeline

• Study Start: 2022-09-21
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2023-07
• Study First Submitted: 2023-07-31
• Study First Submitted QC: 2023-07-31
• Last Update Submitted: 2023-07-31
• Study First Posted: 2023-08-08
• Last Update Posted: 2023-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

Inclusion Criteria

• Age 18 - 40 years
• Diagnosed with Polycystic Ovarian Syndrome based on Rotterdam criteria
• Body Mass Index (BMI) < 40 Kg/m²

Exclusion Criteria

• Age less than 18 years or more than 40 years
• Co-morbid conditions including (diabetes mellitus, essential hypertension, and thyroid disease)
• Patients planning for conception.
• Body Mass Index > 40 Kg/m²

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 (D)	Cabergoline 0.5 MG	25 Patients administered Cabergoline (Pergoline) Tablets of 0.5 mg dose per oral once weekly for 90 days duration.
Group 1 (M)	Metformin Hydrochloride 500 MG	25 Patients administered Metformin (Glucophage) Tablets of 500 mg per oral twice daily for 90 days duration.
Group 3 (MD)	Metformin Hydrochloride 500 MG + Cabergoline 0.5 MG	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.

Primary Outcome Measures

Name	Time	Method
Serum Anti-Müllerian hormone (AMH)	at Baseline, and after 90 days	Measured in ng/mL as a part of hormone status changes analysis
Mean number of dominant follicles (DF)	at Baseline, and after 90 days	Calculated by ultrasonography as a part of the ultrasonic analysis
Serum Anti-GAD antibody	at Baseline, and after 90 days	Measured in ng/mL as a part of inflammatory markers analysis
Mean Resistive Index (RI)	at Baseline, and after 90 days	Calculated by ultrasonography as a part of the ultrasonic analysis
Serum Testosterone	at Baseline, and after 90 days	Measured in ng/mL as a part of hormone status changes analysis
Serum Follicular Stimulating Hormone (FSH)	at Baseline, and after 90 days	Measured in mIU/mL as a part of hormone status changes analysis
Serum Prolactin (PRL)	at Baseline, and after 90 days	Measured in ng/mL as a part of hormone status changes analysis
Serum Anti-GnRH antibody	at Baseline, and after 90 days	Measured in pg/mL as a part of inflammatory markers analysis
Body Mass Index (BMI)	at Baseline, and after 90 days	Measured in Kg/m² as a part of hormone status changes analysis
Serum Luteinizing hormone (LH)	at Baseline, and after 90 days	Measured in mIU/mL as a part of hormone status changes analysis
Serum IL-18 Level	at Baseline, and after 90 days	Measured in pg/mL as a part of inflammatory markers analysis

Trial Locations

Locations (1)

Maternity and Pediatric Teaching Hospital; 🇮🇶 Al Qādisīyah, Al-Qādisiyyah Governorate, Iraq