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

• Sponsor: Al-Rasheed University College (Other)
• Overall Status: Completed
• CT.gov ID: NCT05981742
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arms: 3
• Actual Duration (Months): 6.3
• Patients Per Site Per Month: 12

Study Details

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
• 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: Sep 21, 2022
• Actual Primary Completion Date: Mar 31, 2023
• Actual Study Completion Date: Mar 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) [at Baseline, and after 90 days]

   Measured in Kg/m² as a part of hormone status changes analysis

2. Serum Anti-Müllerian hormone (AMH) [at Baseline, and after 90 days]

   Measured in ng/mL as a part of hormone status changes analysis

3. Serum Testosterone [at Baseline, and after 90 days]

   Measured in ng/mL as a part of hormone status changes analysis

4. Serum Luteinizing hormone (LH) [at Baseline, and after 90 days]

   Measured in mIU/mL as a part of hormone status changes analysis

5. Serum Follicular Stimulating Hormone (FSH) [at Baseline, and after 90 days]

   Measured in mIU/mL as a part of hormone status changes analysis

6. Serum Prolactin (PRL) [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) [at Baseline, and after 90 days]

   Calculated by ultrasonography as a part of the ultrasonic analysis

8. Mean Resistive Index (RI) [at Baseline, and after 90 days]

   Calculated by ultrasonography as a part of the ultrasonic analysis

9. Serum Anti-GAD antibody [at Baseline, and after 90 days]

   Measured in ng/mL as a part of inflammatory markers analysis

10. Serum Anti-GnRH antibody [at Baseline, and after 90 days]

    Measured in pg/mL as a part of inflammatory markers analysis

11. Serum IL-18 Level [at Baseline, and after 90 days]

    Measured in pg/mL as a part of inflammatory markers analysis

Eligibility Criteria

Criteria

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

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hayder Adnan Fawzi, Associate Professor, Al-Rasheed University College
• ClinicalTrials.gov Identifier: NCT05981742
• Other Study ID Numbers: AR2023101
• First Posted: Aug 8, 2023
• Last Update Posted: Aug 8, 2023
• Last Verified: Jul 1, 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, Associate Professor, Al-Rasheed University College: polycystic ovary syndrom; hormones; endometrial resistive index; metformin; Cabergoline
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Metformin; Cabergoline

Study Results

No Results Posted as of Aug 8, 2023