Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS
1 other identifier
interventional
75
1 country
1
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:
- 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?
- 5.Group 1 (M): 25 Patients, Received Metformin 500mg per oral twice daily for 90 days duration.
- 6.Group 2 (D): 25 Patients, Received Dostinex (Pergolin) 0.5 mg per oral (single dose per/week).
- 7.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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2022
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedFirst Submitted
Initial submission to the registry
July 31, 2023
CompletedFirst Posted
Study publicly available on registry
August 8, 2023
CompletedAugust 8, 2023
July 1, 2023
6 months
July 31, 2023
July 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
Body Mass Index (BMI)
Measured in Kg/m² as a part of hormone status changes analysis
at Baseline, and after 90 days
Serum Anti-Müllerian hormone (AMH)
Measured in ng/mL as a part of hormone status changes analysis
at Baseline, and after 90 days
Serum Testosterone
Measured in ng/mL as a part of hormone status changes analysis
at Baseline, and after 90 days
Serum Luteinizing hormone (LH)
Measured in mIU/mL as a part of hormone status changes analysis
at Baseline, and after 90 days
Serum Follicular Stimulating Hormone (FSH)
Measured in mIU/mL as a part of hormone status changes analysis
at Baseline, and after 90 days
Serum Prolactin (PRL)
Measured in ng/mL as a part of hormone status changes analysis
at Baseline, and after 90 days
Mean number of dominant follicles (DF)
Calculated by ultrasonography as a part of the ultrasonic analysis
at Baseline, and after 90 days
Mean Resistive Index (RI)
Calculated by ultrasonography as a part of the ultrasonic analysis
at Baseline, and after 90 days
Serum Anti-GAD antibody
Measured in ng/mL as a part of inflammatory markers analysis
at Baseline, and after 90 days
Serum Anti-GnRH antibody
Measured in pg/mL as a part of inflammatory markers analysis
at Baseline, and after 90 days
Serum IL-18 Level
Measured in pg/mL as a part of inflammatory markers analysis
at Baseline, and after 90 days
Study Arms (3)
Group 1 (M)
ACTIVE COMPARATOR25 Patients administered Metformin (Glucophage) Tablets of 500 mg per oral twice daily for 90 days duration.
Group 2 (D)
ACTIVE COMPARATOR25 Patients administered Cabergoline (Pergoline) Tablets of 0.5 mg dose per oral once weekly for 90 days duration.
Group 3 (MD)
ACTIVE COMPARATOR25 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.
Interventions
Brand name: (Glucophage) Tablets per oral / Twice daily / 90 days duration
Brand name: (Pergoline) Tablets per oral / single dose per week / 90 days duration
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
Eligibility Criteria
You may qualify if:
- Age 18 - 40 years
- Diagnosed with Polycystic Ovarian Syndrome based on Rotterdam criteria
- Body Mass Index (BMI) \< 40 Kg/m²
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maternity and Pediatric Teaching Hospital
Al Qādisīyah, Al-Qādisiyyah Governorate, 58001, Iraq
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 31, 2023
First Posted
August 8, 2023
Study Start
September 21, 2022
Primary Completion
March 31, 2023
Study Completion
March 31, 2023
Last Updated
August 8, 2023
Record last verified: 2023-07