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

July 31, 2023 updated by: Hayder Adnan Fawzi, Al-Rasheed University College

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
    • Al-Qādisiyyah Governorate
      • Al Qādisīyah, Al-Qādisiyyah Governorate, Iraq, 58001
        • Maternity and Pediatric Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2022

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

July 31, 2023

First Submitted That Met QC Criteria

July 31, 2023

First Posted (Actual)

August 8, 2023

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AR2023101

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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