What this trial studies
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 in scope
- Polycystic Ovary Syndrome
- Menopause
Interventions
- Not specified in the public record.
Who can join
Women only · Ages 18 Years and up · Accepts healthy volunteers.
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
Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.
Where it’s happening
| City | State / Region | Facility | Site status |
|---|---|---|---|
| Galveston | Texas | University of Texas Medical Branch | Unknown |
Status & timeline
- Overall status: Completed
- Study type: Observational
- Phase: N/A
- Start date: 2023-03-27
- Primary completion: 2024-08-31
- Last update posted: 2025-02-17
- First posted: 2023-03-15
Sponsor & contact
Lead sponsor: The University of Texas Medical Branch, Galveston (Other)
For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.
Outcome measures
Primary outcomes
- Qualitative Interview (Baseline)
A virtual platform (ie. Zoom) will be used to conduct semi-structured interviews, which are expected to last approximately 60 minutes. Scripting will be followed to limit variability and ensure measurements are applied similarly across the entire study period. Open-ended questions will be included in the script that will query participants about topics such as barriers to behaviors, facilitators (intrapersonal and… - PROMIS Physical Function (10a) (Baseline)
The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any… - PROMIS Fatigue (Baseline)
The PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living.The score of each question are summed and then used to generate a T-score. A T-score of 50 indicates average fatigue.… - PROMIS Sleep Disturbance (Baseline)
The PROMIS Sleep Disturbance questionnaire has 4 questions that ask participants about their perceptions of sleep quality, sleep depth, and restoration associated with sleep in the last 7 days on a five point scale from 'not at all' to 'very much'. The score of each question are summed and then used to generate a T-score. A T-score of 50 indicates… - PROMIS Sleep-related Impairment (Baseline)
The PROMIS Sleep-related Impairment questionnaire has 4 questions that ask participants about alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness in the last 7 days on a five point scale from 'not at all' to 'very much'.A T-score of 50 indicates average sleep related impairment. A…
Related ClearedRx care
If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.
Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT05769426 before contacting a site.
ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.