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Completed

NCT Number: NCT05981742

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

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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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Maternity and Pediatric Teaching Hospital

Al Qādisīyah, Al-Qādisiyyah Governorate, 58001, Iraq

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metformin Hydrochloride 500 MG

Drug

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

Cabergoline 0.5 MG

Drug

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

Metformin Hydrochloride 500 MG + Cabergoline 0.5 MG

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

Primary outcomes

  1. Body Mass Index (BMI)

    Time frame: at Baseline, and after 90 days

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

  2. 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

  3. Serum Testosterone

    Time frame: at Baseline, and after 90 days

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

  4. Serum Luteinizing hormone (LH)

    Time frame: at Baseline, and after 90 days

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

  5. 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

  6. Serum Prolactin (PRL)

    Time frame: 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)

    Time frame: at Baseline, and after 90 days

    Calculated by ultrasonography as a part of the ultrasonic analysis

  8. Mean Resistive Index (RI)

    Time frame: at Baseline, and after 90 days

    Calculated by ultrasonography as a part of the ultrasonic analysis

  9. Serum Anti-GAD antibody

    Time frame: at Baseline, and after 90 days

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

  10. Serum Anti-GnRH antibody

    Time frame: at Baseline, and after 90 days

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

  11. Serum IL-18 Level

    Time frame: at Baseline, and after 90 days

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

Sponsors and collaborators

Lead sponsor

Al-Rasheed University College

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 8, 2023
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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