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

Primary Purpose

Polycystic Ovary Syndrome

Status

Completed

Phase

Phase 2

Locations

Iraq

Study Type

Interventional

Intervention

Metformin Hydrochloride 500 MG

Cabergoline 0.5 MG

Metformin Hydrochloride 500 MG + Cabergoline 0.5 MG

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring polycystic ovary syndrom, hormones, endometrial resistive index, metformin, Cabergoline

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Maternity and Pediatric Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Group 1 (M)

Group 2 (D)

Group 3 (MD)

Arm Description

25 Patients administered Metformin (Glucophage) Tablets of 500 mg per oral twice daily for 90 days duration.

25 Patients administered Cabergoline (Pergoline) Tablets of 0.5 mg dose per oral once weekly for 90 days duration.

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.

Outcomes

Primary Outcome Measures

Body Mass Index (BMI)

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

Serum Anti-Müllerian hormone (AMH)

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

Serum Testosterone

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

Serum Luteinizing hormone (LH)

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

Serum Follicular Stimulating Hormone (FSH)

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

Serum Prolactin (PRL)

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

Mean number of dominant follicles (DF)

Calculated by ultrasonography as a part of the ultrasonic analysis

Mean Resistive Index (RI)

Calculated by ultrasonography as a part of the ultrasonic analysis

Serum Anti-GAD antibody

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

Serum Anti-GnRH antibody

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

Serum IL-18 Level

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05981742

First Posted

July 31, 2023

Last Updated

July 31, 2023

Sponsor

Al-Rasheed University College

1. Study Identification

Unique Protocol Identification Number

NCT05981742

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

September 21, 2022 (Actual)

Primary Completion Date

March 31, 2023 (Actual)

Study Completion Date

March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Al-Rasheed University College

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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: What are the effects of the tested regimens on Body mass index (BMI)? What are the effects of the tested regimens on hormonal status? What are the effects of the tested regimens on uterine artery resistive index ? What are the effects of the tested regimens on some inflammatory markers? Participants will be separated into two groups: Group 1 (M): 25 Patients, Received Metformin 500mg per oral twice daily for 90 days duration. Group 2 (D): 25 Patients, Received Dostinex (Pergolin) 0.5 mg per oral (single dose per/week). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1 (M)

Arm Type

Active Comparator

Arm Description

25 Patients administered Metformin (Glucophage) Tablets of 500 mg per oral twice daily for 90 days duration.

Arm Title

Group 2 (D)

Arm Type

Active Comparator

Arm Description

25 Patients administered Cabergoline (Pergoline) Tablets of 0.5 mg dose per oral once weekly for 90 days duration.

Arm Title

Group 3 (MD)

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Metformin Hydrochloride 500 MG

Intervention Description

Brand name: (Glucophage) Tablets per oral / Twice daily / 90 days duration

Intervention Type

Drug

Intervention Name(s)

Cabergoline 0.5 MG

Intervention Description

Brand name: (Pergoline) Tablets per oral / single dose per week / 90 days duration

Intervention Type

Drug

Intervention Name(s)

Metformin Hydrochloride 500 MG + Cabergoline 0.5 MG

Intervention Description

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

Primary Outcome Measure Information:

Title

Body Mass Index (BMI)

Description

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

Time Frame