Clinical trial · Observational
Health Risks and Barriers to Management Across the PCOS Lifespan
NCT05769426CI-TRIAL-00086056HERBScompletedClinicalTrials.gov clinicaltrialsProvenance
- 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 overall objective of the proposed pilot project is to explore health literacy and barriers to management of PCOS across the lifespan and determine whether the cardiometabolic risks of PCOS extend beyond menopause. The investigators hypothesize that barriers to PCOS management exist and cardiometabolic risks for this population are magnified by aging and menopause.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Menopause | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- PCOS-PRE
- description
- 20 pre-menopausal women who have been diagnosed with polycystic ovarian syndrome (PCOS) will be recruited for this cohort. Participants in this group will complete a semi-structured virtual interview about barriers to healthy behaviors, self-efficacy and health literacy. The will also complete a battery of surveys related to following domains: sleep, anxiety, depression, satisfaction, physical activity, and dietary habits.
- label
- PCOS-POST
- description
- 20 post-menopausal women who have been diagnosed with polycystic ovarian syndrome (PCOS) will be recruited to this cohort. Participants in this group will complete a semi-structured virtual interview and a battery of surveys related to following domains: sleep, anxiety, depression, satisfaction, physical activity, and dietary habits. They will also complete a single in-person visit to the University of Texas Medical Branch where they will undergo a DEXA scan, anthropometric measurements and blood draw.
- label
- CON-POST
- description
- 20 post-menopausal women who have not been diagnosed with polycystic ovarian syndrome (PCOS) will be recruited for this cohort. Participants in this group will complete a battery of surveys related to following domains: sleep, anxiety, depression, satisfaction, physical activity, and dietary habits. They will also complete a single in-person visit to the University of Texas Medical Branch where they will undergo a DEXA scan, anthropometric measurements and blood draw.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All races and ethnicities * Females who are of reproductive age (18-40 years) \[PCOS-PRE only\] * Females who are (≥ 50 years) and post-menopausal (no menstruation within the last 12 months) \[PCOS-POST and CON-POST only\] * Score of 3 or more on Self-administered screener to screen for PCOS and/or diagnosis of PCOS (ICD-10 code E28.2 or other) \[PCOS-PRE and PCOS-POST only\] * Score of 0-2 on Self-administered screener to screen for PCOS and no self-reported history of PCOS or hyperandrogenism \[CON-POST only\] * Access to an electronic device that have virtual/video capabilities \[PCOS-PRE and PCOS-POST only\] * BMI 18.5-40 kg/m2 * Able to read and speak English Exclusion Criteria: * Current smoker * Alcohol abuse * Currently pregnant or lactating * Recent (within 3 years) diagnosis/treatment of cancer (excluding basal cell carcinoma) * Hormone replacement therapy use within the last 3 months * Surgical menopause (Oophorectomy or other surgical cause of menopause) * Prisoner/TDCJ * Any other condition or event considered exclusionary by study PIs
References
Publications (1)
- DERIVEDDouglas CC, Hashmi A, Mclain A, Arentson-Lantz EJ. A mixed-method analysis of health literacy and indicators of well-being in women with polycystic ovary syndrome across the lifespan. Ther Adv Reprod Health. 2026 Feb 22;20:26334941261426089. doi: 10.1177/26334941261426089. eCollection 2026 Jan-Dec. PMID 41738001