Clinical trial · Observational
Phenotype and Epidemiology of the Polycystic Ovary Syndrome (PCOS) in Colombia (PEP - Colombia) Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational study is to know the prevalence of PCOS among economically productive and reproductive age women from Medellín and the Valle de Aburrá, Colombia. The main questions it aims to answer are: 1. What is the phenotypic distribution of PCOS detected in women seeking medical attention as a requirement for employment in Medellín and the Valle de Aburrá, Colombia? 2. What is the effect of environmental factors, such as geographical location and diet, and biological factors (such as obesity and ethnicity/race) on the prevalence and phenotype of PCOS in this populatión? Participants will undergo anthropometric measurements and physical examination for hirsutism, acne, alopecia, acanthosis nigricans, and thyroid enlargement. During the initial visit, a transvaginal or transabdominal pelvic ultrasonography will be performed. A sample of venous blood will be collected in plain tubes for serum cryopreservation and for immediate glucose estimation. Some participants will be rescheduled for a second evaluation visit for additional assessment when they have a possible PCOs.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endocrine System Diseases | — | UNRESOLVED | — |
| Hyperandrogenism | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnostic Ultrasound | Diagnostic Test | — | UNRESOLVED |
| Venous puncture | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Prevalence of PCOS
- timeFrame
- Six months
- description
- Prevalence of PCOS among a medically unselected population-based sample representing the Latino population. In addition, Percentage of participants with phenotype A, B, C or D, among participants diagnosed with PCOS.
Secondary outcomes (1)
- measure
- Percentage of participants with obesity, endocrine disorders, metabolic syndrome, hyperandrogenism, hirsutism, oligomenorrhea, anovulation and irregular menses
- timeFrame
- Six months
- description
- Percentage of participants with obesity, endocrine disorders, metabolic syndrome, hyperandrogenism, hirsutism, oligomenorrhea, anovulation and irregular menses among the study population, which will also have a detailed description of their demographic characteristics
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available