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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-21

Study Completion Date

2023-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1 (M)

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

Group Type ACTIVE_COMPARATOR

Metformin Hydrochloride 500 MG

Intervention Type DRUG

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

Group 2 (D)

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

Group Type ACTIVE_COMPARATOR

Cabergoline 0.5 MG

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Metformin Hydrochloride 500 MG + Cabergoline 0.5 MG

Intervention Type DRUG

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

Interventions

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Metformin Hydrochloride 500 MG

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

Intervention Type DRUG

Cabergoline 0.5 MG

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No