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

Al-Rasheed University College

Status and phase: Completed; Phase 2

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Cabergoline 0.5 MG; Drug: Metformin Hydrochloride 500 MG; Drug: Metformin Hydrochloride 500 MG + Cabergoline 0.5 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05981742

AR2023101

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

75 participants in 3 patient groups

Group 1 (M)

Active Comparator group

Description:

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

Treatment:

Drug: Metformin Hydrochloride 500 MG

Group 2 (D)

Active Comparator group

Description:

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

Treatment:

Drug: Cabergoline 0.5 MG

Group 3 (MD)

Active Comparator group

Description:

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.

Treatment:

Drug: Metformin Hydrochloride 500 MG + Cabergoline 0.5 MG