Clinical trial NCT05981742: Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS
Official title: Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Polycystic Ovary Syndrome
Keywords: polycystic ovary syndrom
hormones
endometrial resistive index
metformin
Cabergoline
Lead sponsor: Al-Rasheed University College
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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.


Eligibility criteria: 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

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: at Baseline, and after 90 days
measure: Serum Anti-Müllerian hormone (AMH)
timeFrame: at Baseline, and after 90 days
measure: Serum Testosterone
timeFrame: at Baseline, and after 90 days
measure: Serum Luteinizing hormone (LH)
timeFrame: at Baseline, and after 90 days
measure: Serum Follicular Stimulating Hormone (FSH)
timeFrame: at Baseline, and after 90 days
measure: Serum Prolactin (PRL)
timeFrame: at Baseline, and after 90 days
measure: Mean number of dominant follicles (DF)
timeFrame: at Baseline, and after 90 days
measure: Mean Resistive Index (RI)
timeFrame: at Baseline, and after 90 days
measure: Serum Anti-GAD antibody
timeFrame: at Baseline, and after 90 days
measure: Serum Anti-GnRH antibody
timeFrame: at Baseline, and after 90 days
measure: Serum IL-18 Level
timeFrame: at Baseline, and after 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Al Qādisīyah
country: Iraq
facility: Maternity and Pediatric Teaching Hospital
state: Al-Qādisiyyah Governorate
Study officials:
affiliation: University of Al-Qadisiyah
name: Inas Naser Hamad, B.Sc. Pharmacy
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Al-Qadisiyah
name: Sinaa Abdul Amir Kadhim, Ph.D Pharmacology
role: STUDY_DIRECTOR
affiliation: Al-Mustafa University College
name: Hayder Adnan Fawzi, Ph.D Clinical Pharmacy
role: STUDY_CHAIR
References: