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Health Risks and Barriers to Management Across the PCOS Lifespan
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:
🦠 Polycystic Ovary Syndrome 🦠 Menopause
🗓️ Study Start (Actual) 27 March 2023
🗓️ Primary Completion (Estimated) 31 August 2024
✅ Study Completion (Estimated) 31 December 2024
👥 Enrollment (Estimated) 60
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Galveston, Texas, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 3 March 2023
  • First Submitted that Met QC Criteria 3 March 2023
  • First Posted 15 March 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 February 2024
  • Last Update Posted 26 February 2024
  • Last Verified February 2024
I'm interested ...!!