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

• ClinicalTrials.gov Identifier: NCT05981742
• Recruitment Status: Completed
• First Posted: August 8, 2023
• Last Update Posted: August 8, 2023
• Sponsor: Al-Rasheed University College
• Information provided by (Responsible Party): Hayder Adnan Fawzi, Al-Rasheed University College

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Polycystic Ovary Syndrome	Drug: Metformin Hydrochloride 500 MG; Drug: Cabergoline 0.5 MG; Drug: Metformin Hydrochloride 500 MG + Cabergoline 0.5 MG	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS
• Actual Study Start Date: September 21, 2022
• Actual Primary Completion Date: March 31, 2023
• Actual Study Completion Date: March 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Group 1 (M); 25 Patients administered Metformin (Glucophage) Tablets of 500 mg per oral twice daily for 90 days duration.	Drug: Metformin Hydrochloride 500 MG; Brand name: (Glucophage) Tablets per oral / Twice daily / 90 days duration
Active Comparator: Group 2 (D); 25 Patients administered Cabergoline (Pergoline) Tablets of 0.5 mg dose per oral once weekly for 90 days duration.	Drug: Cabergoline 0.5 MG; Brand name: (Pergoline) Tablets per oral / single dose per week / 90 days duration
Active Comparator: Group 3 (MD); 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.	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

Outcome Measures

Primary Outcome Measures :

1. Body Mass Index (BMI) [ Time Frame: at Baseline, and after 90 days ]
   Measured in Kg/m² as a part of hormone status changes analysis
2. Serum Anti-Müllerian hormone (AMH) [ Time Frame: at Baseline, and after 90 days ]
   Measured in ng/mL as a part of hormone status changes analysis
3. Serum Testosterone [ Time Frame: at Baseline, and after 90 days ]
   Measured in ng/mL as a part of hormone status changes analysis
4. Serum Luteinizing hormone (LH) [ Time Frame: at Baseline, and after 90 days ]
   Measured in mIU/mL as a part of hormone status changes analysis
5. Serum Follicular Stimulating Hormone (FSH) [ Time Frame: at Baseline, and after 90 days ]
   Measured in mIU/mL as a part of hormone status changes analysis
6. Serum Prolactin (PRL) [ Time Frame: at Baseline, and after 90 days ]
   Measured in ng/mL as a part of hormone status changes analysis
7. Mean number of dominant follicles (DF) [ Time Frame: at Baseline, and after 90 days ]
   Calculated by ultrasonography as a part of the ultrasonic analysis
8. Mean Resistive Index (RI) [ Time Frame: at Baseline, and after 90 days ]
   Calculated by ultrasonography as a part of the ultrasonic analysis
9. Serum Anti-GAD antibody [ Time Frame: at Baseline, and after 90 days ]
   Measured in ng/mL as a part of inflammatory markers analysis
10. Serum Anti-GnRH antibody [ Time Frame: at Baseline, and after 90 days ]
    Measured in pg/mL as a part of inflammatory markers analysis
11. Serum IL-18 Level [ Time Frame: at Baseline, and after 90 days ]
    Measured in pg/mL as a part of inflammatory markers analysis

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Iraq

Maternity and Pediatric Teaching Hospital

Al Qādisīyah, Al-Qādisiyyah Governorate, Iraq, 58001

Sponsors and Collaborators

Al-Rasheed University College

Investigators

• Principal Investigator: Inas Naser Hamad, B.Sc. Pharmacy; University of Al-Qadisiyah
• Study Director: Sinaa Abdul Amir Kadhim, Ph.D Pharmacology; University of Al-Qadisiyah
• Study Chair: Hayder Adnan Fawzi, Ph.D Clinical Pharmacy; Al-Mustafa University College

More Information

• Responsible Party: Hayder Adnan Fawzi, Associate Professor, Al-Rasheed University College
• ClinicalTrials.gov Identifier: NCT05981742
• Other Study ID Numbers: AR2023101
• First Posted: August 8, 2023
• Last Update Posted: August 8, 2023
• Last Verified: July 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Hayder Adnan Fawzi, Al-Rasheed University College:

polycystic ovary syndrom; hormones; endometrial resistive index; metformin; Cabergoline

Additional relevant MeSH terms:

Polycystic Ovary Syndrome; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Metformin; Cabergoline; Hypoglycemic Agents; Physiological Effects of Drugs; Antiparkinson Agents; Anti-Dyskinesia Agents; Dopamine Agonists; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action