Understanding Polycystic Ovary Syndrome in Colombian Women
Phenotype and Epidemiology of the Polycystic Ovary Syndrome (PCOS) in Colombia (PEP - Colombia) Study.
Instituto de fertilidad humana, InSer · NCT05926115
This study looks at how common Polycystic Ovary Syndrome (PCOS) is among working women in Medellín, Colombia, and what factors might affect it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 626 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Instituto de fertilidad humana, InSer (other) |
| Locations | 1 site (Sabaneta, Antioquia) |
| Trial ID | NCT05926115 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine the prevalence of Polycystic Ovary Syndrome (PCOS) among economically productive women of reproductive age in Medellín and the Valle de Aburrá, Colombia. It will assess the phenotypic distribution of PCOS in women seeking medical attention for employment and explore the impact of environmental and biological factors on its prevalence. Participants will undergo physical examinations, anthropometric measurements, and imaging studies, along with blood sample collection for further analysis. The study seeks to gather comprehensive data to better understand PCOS in this specific population.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 45 years who are seeking medical attention for employment.
Not a fit: Women who are pregnant or postmenopausal will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and management of PCOS in Colombian women.
How similar studies have performed: Other studies have shown success in understanding PCOS prevalence and phenotypes in different populations, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Women aged 18 to 45 years. 2. Participants with thyroid dysfunction on medication will be included only if their TSH level is normal (prior to or at re-evaluation) 3. Participants with hyperprolactinemia will be included only if their prolactin (PRL) level is normal (prior to or at re-evaluation) b) Exclusion criteria a. Women who are pregnant at the time of evaluation b. Postmenopausal women Exclusion Criteria: 1. Women who are pregnant at the time of evaluation 2. Postmenopausal women
Where this trial is running
Sabaneta, Antioquia
- Colmédicos S.A.S — Sabaneta, Antioquia, Colombia (RECRUITING)
Study contacts
- Study coordinator: Walter E Osorio, M.D
- Email: wosorio@inser.com.co
- Phone: +57 3002213567
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.
Conditions: Polycystic Ovary Syndrome, Hyperandrogenism, Endocrine System Diseases, Polycystic Ovary, Hirsutism, Oligomenorrhea, Anovulation, Menses, Irregular