Polycystic Ovary SyndromeNCT06479434
Serum Biomarker Levels Improvement in Poly Cystic Ovarian Syndrome: Impact of Metformin Compared to Healthy Controls
A study testing Metformin in people with Polycystic Ovary Syndrome and Insulin Resistance, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The goal of this interventional study is to assess the effect of drug metformin in improving the fertility hormones and reducing the inflammatory hormones in polycystic ovarian syndrome (PCOS) patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Insulin Resistance
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Jun 2024to 2 Oct 2025
- Phase
- Interventional
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients Falling into PCOS as per Rotterdam criteria
Who cannot join
- Systemic diseases like atherosclerosis,
- Diabetes mellitus
- Hypertension
- congenital adrenal hyperplasia, androgen secreting tumors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Serum Biomarkers in Polycystic Ovarian Syndrome (PCOS) Females With and Without Metformin Versus Healthy Controls
The goal of this interventional study is to assess the effect of drug metformin in improving the fertility hormones and reducing the inflammatory hormones in polycystic ovarian syndrome (PCOS) patients. We wish to answer the question whether metformin is necessary to improve PCOS symptoms versus simple lifestyle modification.
Participants once diagnosed with PCOS will be given metformin to be sued for 8 weeks. They will be asked to provide blood samples on day 0 and after 8 weeks of metformin use. The blood sample will be used to measure the hormonal and inflammatory profile. In addition, they will be required to compete a questionnaire regarding symptoms such as decrease in facial hair growth, improvement in menstrual cycle etc.
- Conditions
- Polycystic Ovary Syndrome, Insulin Resistance
- Being tested
- Metformin
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Females diagnosed with polycystic syndrome will be given metformin tablets for 8 weeks and followed up. Blood samples will be collected along with anthropometric data (weight (kg), height (m) etc)
| Study group | Role | What they receive |
|---|---|---|
| Metformin Treated PCO | Experimental | After taking informed consent demographic data like name, age, anthropometric measurements (blood pressure, BMI, weight, height)will be recorded by researcher Body mass index (BMI), waist circumference, waist to hip ratio will be evaluated. Blood samples will be collected after an overnight fast of 8 to 10 hours. Then metformin will be given to subjects a dose of 500 mg three times a day for 8 weeks. Serum biomarkers and inflammatory markers will be assessed at day 0 and after 8 weeks post metformin administration. Receives: Drug: Metformin |
| PCO without Metformin | No intervention | After taking informed consent demographic data like name, age, anthropometric measurements (blood pressure, BMI, weight, height)will be recorded by researcher Body mass index (BMI), waist circumference, waist to hip ratio will be evaluated. Blood samples will be collected after an overnight fast of 8 to 10 hours. . Serum biomarkers and inflammatory markers will be assessed at day 0 only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hormonal profile and menstural Cycle after Metformin use
Serum reproductory hormone levels (follicle stimulating hormone, testosterone), inflammatory hormones (tumor necrosis factor, c reactive protein) will be measured at day 0 and after 8 weeks of intervention
Measured: 8 weeks
Secondary outcomes (1)
Change in symptoms associated with PCO after intervention
Subjects will be asked to score on a Likert scare (0-5) change in the mood swings, menstural cycle frequency, facial hair quantity and quality, and dietary and bowel movement improvement.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start24 Jun 2024
- Primary completion30 May 2025
- Study completion2 Oct 2025
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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Karachi
- Responsible party
- Principal investigator, Sadia Fatima, Aga Khan University
- Investigators
- Sadia Fatima, PhD, Study director, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479434
- Sponsor's protocol ID
- 08232/SC
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Serum Biomarkers in Polycystic Ovarian Syndrome (PCOS) Females With and Without Metformin Versus Healthy Controls
- ClinicalTrials.gov ID
- NCT06479434
- Acronym / sponsor ID
- 08232/SC
- Conditions
- Polycystic Ovary Syndrome, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- University of Karachi
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 2 Oct 2025 (actual)
- First posted
- 28 Jun 2024 (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 study is to assess the effect of drug metformin in improving the fertility hormones and reducing the inflammatory hormones in polycystic ovarian syndrome (PCOS) patients. We wish to answer the question whether metformin is necessary to improve PCOS symptoms versus simple lifestyle modification.
Participants once diagnosed with PCOS will be given metformin to be sued for 8 weeks. They will be asked to provide blood samples on day 0 and after 8 weeks of metformin use. The blood sample will be used to measure the hormonal and inflammatory profile. In addition, they will be required to compete a questionnaire regarding symptoms such as decrease in facial hair growth, improvement in menstrual cycle etc.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin Treated PCO | Experimental | Drug: MetforminAfter taking informed consent demographic data like name, age, anthropometric measurements (blood pressure, BMI, weight, height)will be recorded by researcher Body mass index (BMI), waist circumference, waist to hip ratio will be evaluated. Blood samples will be collected after an overnight fast of 8 to 10 hours. Then metformin will be given to subjects a dose of 500 mg three times a day for 8 weeks. Serum biomarkers and inflammatory markers will be assessed at day 0 and after 8 weeks post metformin administration. |
| PCO without Metformin | No intervention | –After taking informed consent demographic data like name, age, anthropometric measurements (blood pressure, BMI, weight, height)will be recorded by researcher Body mass index (BMI), waist circumference, waist to hip ratio will be evaluated. Blood samples will be collected after an overnight fast of 8 to 10 hours. . Serum biomarkers and inflammatory markers will be assessed at day 0 only. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients Falling into PCOS as per Rotterdam criteria
Key exclusion criteria (4 listed)
- Systemic diseases like atherosclerosis,
- Diabetes mellitus
- Hypertension
- congenital adrenal hyperplasia, androgen secreting tumors
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 |
|---|---|---|
| MetforminFemales diagnosed with polycystic syndrome will be given metformin tablets for 8 weeks and followed up. Blood samples will be collected along with anthropometric data (weight (kg), height (m) etc) | Drug | Metformin Treated PCO |
Primary outcome
Change in hormonal profile and menstural Cycle after Metformin use
Time frame: 8 weeks
Serum reproductory hormone levels (follicle stimulating hormone, testosterone), inflammatory hormones (tumor necrosis factor, c reactive protein) will be measured at day 0 and after 8 weeks of intervention
1 secondary outcome
Change in symptoms associated with PCO after intervention
Time frame: 8 weeks
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 7 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Sadia Fatima, PhD study director
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin in people with Polycystic Ovary Syndrome and Insulin Resistance, run by Aga Khan University at 1 site in Pakistan.
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 1 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 7 Oct 2025. 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 Pakistan. 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.
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?
Change in hormonal profile and menstural Cycle after Metformin use (time frame: 8 weeks). 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 7 Oct 2025.