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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05981742
• Other study ID #: AR2023101
• Status: Completed
• Phase: Phase 2
• Start date: September 21, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: July 2023
• Source: Al-Rasheed University College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

Drug:
• Metformin Hydrochloride 500 MG
Brand name: (Glucophage) Tablets per oral / Twice daily / 90 days duration
• Cabergoline 0.5 MG
Brand name: (Pergoline) Tablets per oral / single dose per week / 90 days duration
• 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

Locations

Country	Name	City	State
Iraq	Maternity and Pediatric Teaching Hospital	Al Qadisiyah	Al-Qadisiyyah Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Al-Rasheed University College

Country where clinical trial is conducted

Iraq, 

Outcome

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