Polycystic Ovary SyndromeHERBSNCT05769426
Health Risks and Barriers to Management Across the PCOS Lifespan
An observational study of Polycystic Ovary Syndrome and Menopause, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Menopause
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2023to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
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.
Read the detailed description
This proposed research serves to provide preliminary data to determine how the metabolic consequences of menopause are exacerbated in women with PCOS. In addition, the investigators will identify barriers to lifestyle management strategies for women with PCOS across the lifespan. The findings will provide preliminary data to inform future interventions to reduce cardiometabolic risk among postmenopausal women with PCOS. Understanding literacy skills and barriers to PCOS management will facilitate the development of personalized, therapeutic strategies and clear communication between patient-health care provider. Furthermore, these practices will help women with PCOS become more involved in their health care decisions and improve women's health.
Therefore, our specific aims are twofold:
Aim 1. Explore and contrast health literacy and barriers to lifestyle management among reproductive-aged and postmenopausal women with PCOS. Using semi-structured, qualitative interviews and REDCap surveys, the investigators will assess differences in health literacy, self-efficacy, and barriers to lifestyle management practices in groups of women with PCOS who are of reproductive age or post-menopausal.
Aim 2. Assess and compare the metabolic risk of women with PCOS to age and BMI-matched, postmenopausal controls. The cohort of post-menopausal women with PCOS in Aim 1 and a cohort of age and BMI-matched post-menopausal women who have no history of hyperandrogenism/PCOS will complete measurement of cardiometabolic risk factors, androgen profile and body composition via dual energy x-ray absorptiometry.
- Conditions
- Polycystic Ovary Syndrome, Menopause
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PCOS-PRE | 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. | |
| PCOS-POST | 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. | |
| CON-POST | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Interview
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 environmental), self-efficacy and health literacy.
[PCOS-PRE, PCOS-POST groups only]
Measured: Baseline
PROMIS Physical Function (10a)
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 difficulty' to 'unable to do'. The score of each question are summed and then used to generate a T-score. A T-score of 50 indicates average physical function. A higher T-score indicates higher than average physical function, while a lower T-score indicates lower than average physical function.
Measured: Baseline
PROMIS Fatigue
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. A higher T-score indicates higher than average fatigue, while a lower T-score indicates lower than average fatigue.
Measured: Baseline
PROMIS Sleep Disturbance
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 average sleep disturbance. A higher T-score indicates higher than average sleep disturbance, while a lower T-score indicates lower than average sleep disturbance.
Measured: Baseline
PROMIS Sleep-related Impairment
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 higher T-score indicates higher than average sleep impairment, while a lower T-score indicates lower than average sleep impairment.
Measured: Baseline
PROMIS Depression
The PROMIS Emotional Distress-Depression questionnaire has 4 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days. A T-score of 50 indicates average depressive symptoms. A higher T-score indicates higher than average depressive symptoms, while a lower T-score indicates lower than average depressive symptoms.
Measured: Baseline
PROMIS Anxiety
The PROMIS Anxiety questionnaire has 8 questions that asks participants about feelings of fear, worry, dread, tension, nervousness, restlessness, racing heart, dizziness with a five point scale from 'never' to 'always' over the past 7 days. A T-score of 50 indicates average anxiety. A higher T-score indicates higher than average anxiety while a lower T-score indicates lower than average sleep anxiety.
Measured: Baseline
PROMIS Satisfaction with roles and abilities
The PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'. A T-score of 50 indicates average satisfaction. A higher T-score indicates higher than average satisfaction, while a lower T-score indicates lower than average satisfaction.
Measured: Baseline
PROMIS Ability to participate in social roles and activity
The PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'. A T-score of 50 indicates average ability to participate. A higher T-score indicates higher than average ability to participate, while a lower T-score indicates lower than average ability to participate.
Measured: Baseline
Exercise Self-Efficacy Scale
The Exercise Self-Efficacy Scale is an 8-item questionnaire that assesses the participant's belief in their future ability to exercise three times per week at a moderate intensity for 40= min (upper end of their perceived exertion range) per session. A higher score indicates a greater belief to exercise.
Measured: Baseline
Eating at America's Table Study survey
The Eating at America's Table Study survey is 10 question survey that asks participants to recall the fruits and vegetables they ate last month and then report the frequency of consumption on a ten point scale from never up to 5 or more times per day. A higher score indicates a higher consumption of fruits and vegetables.
Measured: Baseline
Height
Height will be assessed with a standardized stadiometer [PCOS-POST and CON-POST cohorts only]
Measured: Baseline
Weight
Weight will be assessed with a standardized scale [PCOS-POST and CON-POST cohorts only]
Measured: Baseline
Whole body lean mass
Whole body lean mass will be assessed using segmental dual energy x-ray absorptiometry. [PCOS-POST and CON-POST cohorts only]
Measured: Baseline
Appendicular lean mass
Appendicular lean mass will be assessed using segmental dual energy x-ray absorptiometry. [PCOS-POST and CON-POST cohorts only]
Measured: Baseline
Total fat mass
Total fat mass will be assessed using segmental dual energy x-ray absorptiometry. [PCOS-POST and CON-POST cohorts only]
Measured: Baseline
Visceral fat mass
Visceral fat mass will be assessed using segmental dual energy x-ray absorptiometry. [PCOS-POST and CON-POST cohorts only]
Measured: Baseline
Total cholesterol
Total cholesterol will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Measured: Baseline
LDL cholesterol
LDL cholesterol will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Measured: Baseline
HDL cholesterol
HDL cholesterol will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Measured: Baseline
Triglycerides
Triglycerides will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Measured: Baseline
Glucose
Glucose will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Measured: Baseline
Insulin
Insulin will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Measured: Baseline
Hemoglobin A1C
Hemoglobin A1C will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Measured: Baseline
Estradiol
Estradiol will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Measured: Baseline
Testosterone
Testosterone will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Measured: Baseline
Androstenedione
Androstenedione will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Measured: Baseline
Sex hormone binding globulin
Sex hormone binding globulin will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Measured: Baseline
Systolic blood pressure
Systolic blood pressure will be assessed by study staff using standard protocols. [PCOS-POST and CON-POST cohorts only]
Measured: Baseline
Diastolic blood pressure
Diastolic blood pressure will be assessed by study staff using standard protocols. [PCOS-POST and CON-POST cohorts only]
Measured: Baseline
Waist Circumference
Waist Circumference will be assessed by study staff using standard protocols. [PCOS-POST and CON-POST cohorts only]
Measured: Baseline
Hip Circumference
Hip Circumference will be assessed by study staff using standard protocols. [PCOS-POST and CON-POST cohorts only]
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start27 Mar 2023
- Primary completion31 Aug 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily Lantz, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769426
- Sponsor's protocol ID
- 23-0011
- Acronym
- HERBS
- Status last verified
- Feb 2025
- First submitted
- 3 Mar 2023
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Douglas 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.
PubMed 41738001
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Risks and Barriers to Management Across the PCOS Lifespan
- ClinicalTrials.gov ID
- NCT05769426
- Acronym / sponsor ID
- HERBS / 23-0011
- Conditions
- Polycystic Ovary Syndrome, Menopause
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This proposed research serves to provide preliminary data to determine how the metabolic consequences of menopause are exacerbated in women with PCOS. In addition, the investigators will identify barriers to lifestyle management strategies for women with PCOS across the lifespan. The findings will provide preliminary data to inform future interventions to reduce cardiometabolic risk among postmenopausal women with PCOS. Understanding literacy skills and barriers to PCOS management will facilitate the development of personalized, therapeutic strategies and clear communication between patient-health care provider. Furthermore, these practices will help women with PCOS become more involved in their health care decisions and improve women's health.
Therefore, our specific aims are twofold:
Aim 1. Explore and contrast health literacy and barriers to lifestyle management among reproductive-aged and postmenopausal women with PCOS. Using semi-structured, qualitative interviews and REDCap surveys, the investigators will assess differences in health literacy, self-efficacy, and barriers to lifestyle management practices in groups of women with PCOS who are of reproductive age or post-menopausal.
Aim 2. Assess and compare the metabolic risk of women with PCOS to age and BMI-matched, postmenopausal controls. The cohort of post-menopausal women with PCOS in Aim 1 and a cohort of age and BMI-matched post-menopausal women who have no history of hyperandrogenism/PCOS will complete measurement of cardiometabolic risk factors, androgen profile and body composition via dual energy x-ray absorptiometry.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PCOS-PRE | – | –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. |
| PCOS-POST | – | –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. |
| CON-POST | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (8 listed)
- 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]
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Qualitative Interview
Time frame: 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 environmental), self-efficacy and health literacy. [PCOS-PRE, PCOS-POST groups only]
PROMIS Physical Function (10a)
Time frame: 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 difficulty' to 'unable to do'. The score of each question are summed and then used to generate a T-score. A T-score of 50 indicates average physical function. A higher T-score indicates higher than average physical function, while a lower T-score indicates lower than average physical function.
PROMIS Fatigue
Time frame: 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. A higher T-score indicates higher than average fatigue, while a lower T-score indicates lower than average fatigue.
PROMIS Sleep Disturbance
Time frame: 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 average sleep disturbance. A higher T-score indicates higher than average sleep disturbance, while a lower T-score indicates lower than average sleep disturbance.
PROMIS Sleep-related Impairment
Time frame: 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 higher T-score indicates higher than average sleep impairment, while a lower T-score indicates lower than average sleep impairment.
PROMIS Depression
Time frame: Baseline
The PROMIS Emotional Distress-Depression questionnaire has 4 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days. A T-score of 50 indicates average depressive symptoms. A higher T-score indicates higher than average depressive symptoms, while a lower T-score indicates lower than average depressive symptoms.
PROMIS Anxiety
Time frame: Baseline
The PROMIS Anxiety questionnaire has 8 questions that asks participants about feelings of fear, worry, dread, tension, nervousness, restlessness, racing heart, dizziness with a five point scale from 'never' to 'always' over the past 7 days. A T-score of 50 indicates average anxiety. A higher T-score indicates higher than average anxiety while a lower T-score indicates lower than average sleep anxiety.
PROMIS Satisfaction with roles and abilities
Time frame: Baseline
The PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'. A T-score of 50 indicates average satisfaction. A higher T-score indicates higher than average satisfaction, while a lower T-score indicates lower than average satisfaction.
PROMIS Ability to participate in social roles and activity
Time frame: Baseline
The PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'. A T-score of 50 indicates average ability to participate. A higher T-score indicates higher than average ability to participate, while a lower T-score indicates lower than average ability to participate.
Exercise Self-Efficacy Scale
Time frame: Baseline
The Exercise Self-Efficacy Scale is an 8-item questionnaire that assesses the participant's belief in their future ability to exercise three times per week at a moderate intensity for 40= min (upper end of their perceived exertion range) per session. A higher score indicates a greater belief to exercise.
Eating at America's Table Study survey
Time frame: Baseline
The Eating at America's Table Study survey is 10 question survey that asks participants to recall the fruits and vegetables they ate last month and then report the frequency of consumption on a ten point scale from never up to 5 or more times per day. A higher score indicates a higher consumption of fruits and vegetables.
Height
Time frame: Baseline
Height will be assessed with a standardized stadiometer [PCOS-POST and CON-POST cohorts only]
Weight
Time frame: Baseline
Weight will be assessed with a standardized scale [PCOS-POST and CON-POST cohorts only]
Whole body lean mass
Time frame: Baseline
Whole body lean mass will be assessed using segmental dual energy x-ray absorptiometry. [PCOS-POST and CON-POST cohorts only]
Appendicular lean mass
Time frame: Baseline
Appendicular lean mass will be assessed using segmental dual energy x-ray absorptiometry. [PCOS-POST and CON-POST cohorts only]
Total fat mass
Time frame: Baseline
Total fat mass will be assessed using segmental dual energy x-ray absorptiometry. [PCOS-POST and CON-POST cohorts only]
Visceral fat mass
Time frame: Baseline
Visceral fat mass will be assessed using segmental dual energy x-ray absorptiometry. [PCOS-POST and CON-POST cohorts only]
Total cholesterol
Time frame: Baseline
Total cholesterol will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
LDL cholesterol
Time frame: Baseline
LDL cholesterol will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
HDL cholesterol
Time frame: Baseline
HDL cholesterol will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Triglycerides
Time frame: Baseline
Triglycerides will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Glucose
Time frame: Baseline
Glucose will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Insulin
Time frame: Baseline
Insulin will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Hemoglobin A1C
Time frame: Baseline
Hemoglobin A1C will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Estradiol
Time frame: Baseline
Estradiol will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Testosterone
Time frame: Baseline
Testosterone will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Androstenedione
Time frame: Baseline
Androstenedione will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Sex hormone binding globulin
Time frame: Baseline
Sex hormone binding globulin will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Systolic blood pressure
Time frame: Baseline
Systolic blood pressure will be assessed by study staff using standard protocols. [PCOS-POST and CON-POST cohorts only]
Diastolic blood pressure
Time frame: Baseline
Diastolic blood pressure will be assessed by study staff using standard protocols. [PCOS-POST and CON-POST cohorts only]
Waist Circumference
Time frame: Baseline
Waist Circumference will be assessed by study staff using standard protocols. [PCOS-POST and CON-POST cohorts only]
Hip Circumference
Time frame: Baseline
Hip Circumference will be assessed by study staff using standard protocols. [PCOS-POST and CON-POST cohorts only]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Derived from this study: PubMed 41738001Douglas 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Lantz, PhD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome and Menopause, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative Interview (time frame: Baseline). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05769426, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.