Polycystic Ovary SyndromePhase 2NCT05981742
Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS
A Phase 2 study testing Metformin Hydrochloride 500 MG, Cabergoline 0.5 MG and Metformin Hydrochloride 500 MG + Cabergoline 0.5 MG in people with Polycystic Ovary Syndrome, run by Al-Rasheed University College at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Metformin Hydrochloride 500 MG, Cabergoline 0.5 MG and Metformin Hydrochloride 500 MG + Cabergoline 0.5 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteIraq
- Study dates
- 21 Sep 2022to 31 Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 - 40 years
- Diagnosed with Polycystic Ovarian Syndrome based on Rotterdam criteria
- Body Mass Index (BMI) < 40 Kg/m²
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Iraq1 site
Maternity and Pediatric Teaching Hospital
Al Qādisīyah, Al-Qādisiyyah Governorate, 58001
About this study
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:
- What are the effects of the tested regimens on Body mass index (BMI)?
- What are the effects of the tested regimens on hormonal status?
- What are the effects of the tested regimens on uterine artery resistive index ?
- What are the effects of the tested regimens on some inflammatory markers?
Read more
Participants will be separated into two groups:
- Group 1 (M): 25 Patients, Received Metformin 500mg per oral twice daily for 90 days duration.
- Group 2 (D): 25 Patients, Received Dostinex (Pergolin) 0.5 mg per oral (single dose per/week).
- 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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Metformin Hydrochloride 500 MG, Cabergoline 0.5 MG, Metformin Hydrochloride 500 MG + Cabergoline 0.5 MG
- Keywords
- polycystic ovary syndrom, hormones, endometrial resistive index, metformin, Cabergoline
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin Hydrochloride 500 MGDrug
Brand name: (Glucophage) Tablets per oral / Twice daily / 90 days duration
Cabergoline 0.5 MGDrug
Brand name: (Pergoline) Tablets per oral / single dose per week / 90 days duration
Metformin Hydrochloride 500 MG + Cabergoline 0.5 MGDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (M) | Active comparator | 25 Patients administered Metformin (Glucophage) Tablets of 500 mg per oral twice daily for 90 days duration. Receives: Drug: Metformin Hydrochloride 500 MG |
| Group 2 (D) | Active comparator | 25 Patients administered Cabergoline (Pergoline) Tablets of 0.5 mg dose per oral once weekly for 90 days duration. Receives: Drug: Cabergoline 0.5 MG |
| Group 3 (MD) | Active comparator | 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. Receives: Drug: Metformin Hydrochloride 500 MG + Cabergoline 0.5 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
Measured in Kg/m² as a part of hormone status changes analysis
Measured: at Baseline, and after 90 days
Serum Anti-Müllerian hormone (AMH)
Measured in ng/mL as a part of hormone status changes analysis
Measured: at Baseline, and after 90 days
Serum Testosterone
Measured in ng/mL as a part of hormone status changes analysis
Measured: at Baseline, and after 90 days
Serum Luteinizing hormone (LH)
Measured in mIU/mL as a part of hormone status changes analysis
Measured: at Baseline, and after 90 days
Serum Follicular Stimulating Hormone (FSH)
Measured in mIU/mL as a part of hormone status changes analysis
Measured: at Baseline, and after 90 days
Serum Prolactin (PRL)
Measured in ng/mL as a part of hormone status changes analysis
Measured: at Baseline, and after 90 days
Mean number of dominant follicles (DF)
Calculated by ultrasonography as a part of the ultrasonic analysis
Measured: at Baseline, and after 90 days
Mean Resistive Index (RI)
Calculated by ultrasonography as a part of the ultrasonic analysis
Measured: at Baseline, and after 90 days
Serum Anti-GAD antibody
Measured in ng/mL as a part of inflammatory markers analysis
Measured: at Baseline, and after 90 days
Serum Anti-GnRH antibody
Measured in pg/mL as a part of inflammatory markers analysis
Measured: at Baseline, and after 90 days
Serum IL-18 Level
Measured in pg/mL as a part of inflammatory markers analysis
Measured: at Baseline, and after 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start21 Sep 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Rasheed University College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hayder Adnan Fawzi, Al-Rasheed University College
- Investigators
- Inas Naser Hamad, B.Sc. Pharmacy, Principal investigator, University of Al-QadisiyahSinaa Abdul Amir Kadhim, Ph.D Pharmacology, Study director, University of Al-QadisiyahHayder Adnan Fawzi, Ph.D Clinical Pharmacy, Study chair, Al-Mustafa University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981742
- Sponsor's protocol ID
- AR2023101
- Status last verified
- Jul 2023
- First submitted
- 31 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS
- ClinicalTrials.gov ID
- NCT05981742
- Acronym / sponsor ID
- AR2023101
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- polycystic ovary syndrom, hormones, endometrial resistive index, metformin, Cabergoline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Al-Rasheed University CollegeUniversity, hospital or other
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What are the effects of the tested regimens on Body mass index (BMI)?
- What are the effects of the tested regimens on hormonal status?
- What are the effects of the tested regimens on uterine artery resistive index ?
- What are the effects of the tested regimens on some inflammatory markers?
Participants will be separated into two groups:
- Group 1 (M): 25 Patients, Received Metformin 500mg per oral twice daily for 90 days duration.
- Group 2 (D): 25 Patients, Received Dostinex (Pergolin) 0.5 mg per oral (single dose per/week).
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (M) | Active comparator | Drug: Metformin Hydrochloride 500 MG25 Patients administered Metformin (Glucophage) Tablets of 500 mg per oral twice daily for 90 days duration. |
| Group 2 (D) | Active comparator | Drug: Cabergoline 0.5 MG25 Patients administered Cabergoline (Pergoline) Tablets of 0.5 mg dose per oral once weekly for 90 days duration. |
| Group 3 (MD) | Active comparator | Drug: Metformin Hydrochloride 500 MG + Cabergoline 0.5 MG25 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18 - 40 years
- Diagnosed with Polycystic Ovarian Syndrome based on Rotterdam criteria
- Body Mass Index (BMI) < 40 Kg/m²
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin Hydrochloride 500 MGBrand name: (Glucophage) Tablets per oral / Twice daily / 90 days duration | Drug | Group 1 (M) |
| Cabergoline 0.5 MGBrand name: (Pergoline) Tablets per oral / single dose per week / 90 days duration | Drug | Group 2 (D) |
| Metformin Hydrochloride 500 MG + Cabergoline 0.5 MGMetformin 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 | Drug | Group 3 (MD) |
Primary outcome
Body Mass Index (BMI)
Time frame: at Baseline, and after 90 days
Measured in Kg/m² as a part of hormone status changes analysis
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
Serum Testosterone
Time frame: at Baseline, and after 90 days
Measured in ng/mL as a part of hormone status changes analysis
Serum Luteinizing hormone (LH)
Time frame: at Baseline, and after 90 days
Measured in mIU/mL as a part of hormone status changes analysis
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
Serum Prolactin (PRL)
Time frame: at Baseline, and after 90 days
Measured in ng/mL as a part of hormone status changes analysis
Mean number of dominant follicles (DF)
Time frame: at Baseline, and after 90 days
Calculated by ultrasonography as a part of the ultrasonic analysis
Mean Resistive Index (RI)
Time frame: at Baseline, and after 90 days
Calculated by ultrasonography as a part of the ultrasonic analysis
Serum Anti-GAD antibody
Time frame: at Baseline, and after 90 days
Measured in ng/mL as a part of inflammatory markers analysis
Serum Anti-GnRH antibody
Time frame: at Baseline, and after 90 days
Measured in pg/mL as a part of inflammatory markers analysis
Serum IL-18 Level
Time frame: at Baseline, and after 90 days
Measured in pg/mL as a part of inflammatory markers analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inas Naser Hamad, B.Sc. Pharmacy principal investigator
University of Al-Qadisiyah
Sinaa Abdul Amir Kadhim, Ph.D Pharmacology study director
University of Al-Qadisiyah
Hayder Adnan Fawzi, Ph.D Clinical Pharmacy study chair
Al-Mustafa University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin Hydrochloride 500 MG, Cabergoline 0.5 MG and Metformin Hydrochloride 500 MG + Cabergoline 0.5 MG in people with Polycystic Ovary Syndrome, run by Al-Rasheed University College at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (BMI) (time frame: at Baseline, and after 90 days). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.