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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

NCT05981742 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2023-08-08

No results posted yet for this study

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.

Conditions

  • Polycystic Ovary Syndrome

Interventions

DRUG

Metformin Hydrochloride 500 MG

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

DRUG

Cabergoline 0.5 MG

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

Sponsors & Collaborators

  • Al-Rasheed University College

    lead OTHER

Principal Investigators

  • Inas Naser Hamad, B.Sc. Pharmacy · University of Al-Qadisiyah

  • Sinaa Abdul Amir Kadhim, Ph.D Pharmacology · University of Al-Qadisiyah

  • Hayder Adnan Fawzi, Ph.D Clinical Pharmacy · Al-Mustafa University College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-21
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • Iraq

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05981742 on ClinicalTrials.gov