Effect of Metformin on Hormones in Women with Polycystic Ovary Syndrome
Association of Serum Biomarkers in Polycystic Ovarian Syndrome (PCOS) Females With and Without Metformin Versus Healthy Controls
This study is testing if the diabetes drug metformin can help women with polycystic ovary syndrome feel better and improve their hormone levels over 8 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Aga Khan University Academic / other |
| Locations | 1 site (Karachi, Sind) |
| Trial ID | NCT06479434 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the impact of metformin on fertility and inflammatory hormone levels in women diagnosed with polycystic ovary syndrome (PCOS). Participants will receive metformin for 8 weeks and provide blood samples before and after treatment to assess hormonal changes. Additionally, they will complete a questionnaire to report improvements in symptoms such as menstrual regularity and facial hair growth. The study seeks to determine if metformin is necessary for symptom improvement compared to lifestyle modifications alone.
Who should consider this trial
Good fit: Ideal candidates for this study are women diagnosed with polycystic ovary syndrome according to the Rotterdam criteria.
Not a fit: Patients with systemic diseases, diabetes mellitus, hypertension, or androgen-secreting tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of metformin in managing PCOS symptoms and improving hormonal balance.
How similar studies have performed: Previous studies have shown that metformin can be beneficial for women with PCOS, indicating that this approach has been tested with some success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: a) Patients Falling into PCOS as per Rotterdam criteria Exclusion Criteria: 1. Systemic diseases like atherosclerosis, 2. Diabetes mellitus 3. Hypertension 4. congenital adrenal hyperplasia, androgen secreting tumors
Where this trial is running
Karachi, Sind
- Dbbs — Karachi, Sind, Pakistan (Recruiting)
Study contacts
- Study coordinator: Sassi Kanwal, MPhil
- Email: knowledgefonly@gmail.com
- Phone: +92 333 2351728
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.