Pulmonary Disease, Chronic ObstructiveNCT06240078
Impact of COPD on Sexual Health, Loneliness, and Well-being
An observational study of Pulmonary Disease, Chronic Obstructive and Sexual Health, run by Vejle Hospital at 1 site in Denmark.
Trial summary
Summary Person-centered care is a hot topic within healthcare, yet communication about patients' sexual health and intimacy issues remain too hot to handle within healthcare. Research indicates that sexual dysfunction and impaired sexual health are frequent among individuals with chronic obstructive pulmonary disease… Read more about this study
- Who is it for?
- Ages 40 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Sexual Health, Loneliness
- How many people
- 521 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Feb 2024to 19 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 40 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will include individuals aged 40 years or older, encompassing both men and women. The primary focus will be on individuals diagnosed with Chronic Obstructive Pulmonary Disease (COPD), recruited from relevant websites and social media, primarily through the Danish Lung Association platform (www.lungeforeningen.dk). Additionally, a COPD-free control group, controled by age, sex, and relationship status, will serve as a reference group. This comparison group plays a crucial role in identifying COPD-specific challenges. Most non-COPD individuals will be recruited via the 'Aeldresagen.dk' platform. All participants must be capable and willing to complete a public online questionnaire. The study's diverse demographic ensures a comprehensive exploration of COPD-related factors.
Who may be able to join
- COPD Population
- Mild to very servere COPD
- ≥40 years old
- Living in Denmark
- Consent to participate the online survey
- Control Group:
Show all 10Show fewer
- Non-COPD, but wit another chronic/longtern disease
- ≥40 years old
- Living in Denmark
- Consent to participate the online survey
Who cannot join
- COPD Population:
- Unwilling to participate and complete the online survey
- Inability to participate and answer the survey questions in Danish due to cognitive impairment, servere illness, or reading or language barriers
- Control Group:
- COPD
- Unwilling to participate and complete the online survey
- Inability to participate and answer the survey questions in Danish due to cognitive impairment, servere illness, or reading or language barriers
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Vejle Hospital, part of Lillebaelt Hospital
Vejle, Region Syddanmark, 7100
About this study
Official title: Impact of Chronic Obstructive Pulmonary Disease (COPD) on Sexual Health, Loneliness, and Well-being: A Cross-sectional Study of Prevalence and Associated Variables in Individuals With and Without COPD
Summary Person-centered care is a hot topic within healthcare, yet communication about patients' sexual health and intimacy issues remain too hot to handle within healthcare. Research indicates that sexual dysfunction and impaired sexual health are frequent among individuals with chronic obstructive pulmonary disease (COPD). Despite patients expecting healthcare professionals to address intimacy issues; these issues are often neglected, since the topic is a taboo.
This study aims to address a gap in observational research by investigating the physical, psychological and social aspects of sexual health in both men and women with and without COPD. The primary hypothesis of this survey-based cross-sectional study is that COPD negatively impacts sexual health, leading to increased loneliness, relationship dissatisfaction, anxiety and/or depression, along with decreased health-related quality of life and well-being in patients. The study seeks to identify associations between impaired sexual health and these factors.
By fostering a new understanding of these aspects, this study is essential to promote person-centered communication about sexual health, addressing the often overlooked needs and concerns of individuals with COPD. Ultimately, the study has the potential to improve sexual health and overall well-being among individuals with COPD, contributing to a more person-centered approach in COPD care.
Read the detailed description
Objectives The primary objectives of this study are to assess whether impaired sexual health is more prevalent in individuals with COPD compared to those without COPD and to explore its impact on well-being and health-related quality of life. Additionally, the study aims to comprehend the impact of COPD on sexual health by investigating potential associations among selected physical, psychological, and social factors related to sexual health. This understanding is crucial for guiding future studies on identified associations.
The study will examine the following assumptions:
- Impaired sexual health, characterized by a higher prevalence of sexual dysfunction, dissatisfaction, and distress, is more frequent in individuals with COPD than in a control group (individuals without COPD, matched by age, gender, and relationship status).
- COPD has a comprehensive impact on both physical, psychological, and social aspects of sexual health. Impaired sexual health is associated with increased loneliness, relationship dissatisfaction, anxiety and/or depression, as well as decreased health-related quality of life and overall well-being.
Method and materials This study adopts a cross-sectional design, utilizing a patient-reported questionnaire to collect data. The participant pool will encompass individuals aged 40 years or older, including those with COPD and a control group without COPD. The control group will be matched to the COPD sample based on age, gender, and relationship status, enhancing the precision of the exploration of COPD-specific challenges. All participants will be invited to complete a public online questionnaire, with all participants providing electronic informed consent before survey completion.
To explore the impact of COPD on sexual health, including COPD-specific factors, and to assess the perceived effect on quality of life, the questionnaire incorporates various validated instruments. Each instrument will measure a specific aspects related to the physical, psychological, or social dimension of sexual health. Sexual dysfunction and sexual health will be assessed using The PROMIS Sexual Function and Satisfaction Measures (Brief Profile), while emotions and concerns related to sexuality will be identified through The Sexual Distress Scale. Relationship dissatisfaction will be assessed using The Couples Satisfaction Index, loneliness through the UCLA Loneliness Scale, and anxiety/depression via the Hospital Anxiety and Depression Scale. Well-being will be evaluated using the EQ-5D-5L. Individuals with COPD will provide additional insights into the impact of COPD on health through the COPD Assessment Test.
Based on a power calculation (two-sided; p<0.05; power=95%) (26), the study's exploratory approach, and the number of variables, a sample size of minimum 200 participants per group is deemed sufficient to identify associations.
Descriptive statistics, including means, standard deviations, and frequencies, will be employed to report the prevalence of sexual health and summarize data related to COPD-specific challenges. Correlation coefficients will be calculated, and multiple regression analyses will be conducted to identify associations between variables, adjusting for potential confounders. STATA will be used for data analysis. The study results will be reported in accordance with the STROBE guidelines (22).
- Conditions
- Pulmonary Disease, Chronic Obstructive, Sexual Health, Loneliness, Well-Being, Psychological
- Keywords
- COPD, sexual distress, sexual health, anxiety, depression, loneliness, chronic, associations
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Psychological Well-Being, Anxiety Disorders, Depression, Bronchiolitis Obliterans 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 |
|---|---|---|
| COPD group | COPD group: Participants with self-reported COPD (Group 1) | |
| Non-COPD group | Non-COPD group: Participants without self-reported COPD, but with other chronic diseases. A comparison group (Group 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual health acording to The PROMIS Sex FS BF (vers. 2.0)
The PROMIS® Sexual Function and Satisfaction Measures, version 2.0. Brief Profile (PROMIS SexFS BF v2.0) universally assesses Sexual Function and Satisfaction. A general screener item inquires about sexual activity in the past 30 days. Respondents who have been sexually active answer items covering various domain, e.g. Interest in Sexual Activity, Satisfaction with Sex Life, Orgasm Ability and Pleasure, Erectile Function, Vaginal Discomfort and Lubrication. Most items are gender-nonspecific.
Higher scores indicate greater Interest, Satisfaction, Orgasm ability, etc. Each domain's summed raw score is converted to T-scores, standardized to the U.S. general population (mean 50, SD 10). A clinically meaningful cutoff is five points below the population mean. (Weinfurt KP et al. J Sex Med. 2015;12:1961-1974.).
Measured: Day 1
Secondary outcomes (6)
Loneliness according to The UCLA Loneliness Scale
Loneliness is assessed by the UCLA Loneliness Scale (revised), a 20 item scale rated on a 4-point Likert scale, ranging from 1 to 4 ('never' to 'always'). The scale covers the frequency of feelings/symptoms related to loneliness and social isolation, assessing three dimensions: emotional, social, and existential loneliness.
The total sum score ranges from 20 to 80, with higher scores indicating more profound feelings of loneliness.
(Russell DW. UCLA Loneliness Scale (vers 3). Reliability, validity and factor structure. Journal of Personality Assessment. 1996; 66: 20-40.) (Danish version: Lasgaard M. Reliability and validity of the Danish version of the UCLA Loneliness Scale. Personality and Individual Differences. 2007; 42 (7): 1359-1366.)
Measured: Day 1
Well-being according to EQ-5D-5L Health related quality of life according to the EQ-5D-5L
EuroQoL Five-Dimensional Five-Level Questionnaire (EQ-5D-5L) to assess generic HRQL, by comprising two parts:
The first part entails five questions covering five domains of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) on a 5-item Likert-scale. Participants mark their status from 1 to 5 ('no problems' to 'unable to/extreme problems') for each dimension. Responses are combined to create a five-digit number describing health status (ranging from 11111 to 55555), which is converted to a UI using the EQ-5D-5L value set for Denmark.
The second part (VAS) assesses the currently experienced health on a vertical VASr between 0 and 100; the latter indicates the best health state imaginable.
(Jensen CE et al. The Danish EQ-5D-5L Value Set: A Hybrid Model Using cTTO and DCE Data. Appl Health Econ Health Policy. 2021 Jul;19(4):579-591.) (Danish version: Helbredsspørgeskema).
Measured: Day 1
Anxiety and depression according to HADS
The Hospital Anxiety and Depression Scale (HADS) is a 14-item scale consisting of two 7-item subscales assessing anxiety and depression symptoms. Each item is rated on a 4-point Likert scale, ranging from 0 to 3, with higher scores indicating greater levels of anxiety (0-21) and depression (0-21).
Additionally, a total score for the two components can be summed to provide a composite anxiety-depression score, with a maximum of 42 points. Higher scores indicate more severe symptomatology (Zigmond AS, Snaith RP. The Hospital Anxiety And Depression Scale. Acta Psychiatr Scand 1983; 67: 361-370. DOI: 10.1111/j.1600-0447.1983.tb09716.x) (Danish version: Spørgeskema om angst og depression, til brug på hospital (HADS))
Measured: Day 1
Relationship satisfaction according to The Couples Satisfaction Index
The Couples Satisfaction Index assess relationship satisfaction with 16 items (CSI-16). Comprising 5- and 6-point Likert scale items, respondents are prompted to evaluate their satisfaction across various relationship dimensions.
The total score, ranging from 0 to 81 (the sum of response point values), indicates the overall level of relationship satisfaction. Higher scores correspond to heightened relationship satisfaction, whereas scores below 51.5 suggest significant relationship dissatisfaction or distress (ibid.).
(Funk J L; Rogge RD. Testing the ruler with item response theory: Increasing precision of measurement for relationship satisfaction with the Couples Satisfaction Index. Journal of Family Psychology. 2007; 21, 572-583)
- Trillingsgaard T et al. Relationship Help-Seeking in a Danish Population Sample. J Marital Fam Ther. 2019;45(3):380-394. DOI: 10.1111/jmft.12347 Danish version: "Mål for parforholdstilfredshed".
Measured: Day 1
Sexual distress according to The Sexual Distress Scale
The Sexual Distress Scale - Revised (SDS-R) is utilized to assess sexual distress among both males and females. Sexual distress includes emotions and concerns related to sexuality. The scale comprises 13 items, each using a five-point Likert scale with responses ranging from 0 to 4 ('never' to 'always'). Participants rate the frequency of each feeling/symptom, with higher scores indicating higher sexual distress.
The total score ranges from 0 to 52, and a cut-off Total score of ≥11 indicates the presence of sexual distress.
(Santos-Iglesias P et al. A Systematic Review of Sexual Distress Measures. J Sex Med. 2018 May;15(5):625-644. doi: 10.1016/j.jsxm.2018.02.020) (Sood R et al. Association of mindfulness with female sexual dysfunction. Maturitas. 2022 Jul;161:27-32. doi: 10.1016/j.maturitas.2022.02.002.) (Danish version FSDS, 2001)
Measured: Day 1
COPD-impact on health according to CAT
The COPD Assessment Test (CAT) is an 8-item disease-specific questionnaire that assess the impact of COPD on participants' health.
Each item provides six answer options, with scores ranging from 0 to 5. The total score spans from 0 to 40, with higher values indicating poorer health. A suggested cut-off is CAT <10, reflecting fewer symptoms, and CAT ≥10, indicating more symptoms.
(Kakavas S, Papanikolaou A, Kompogiorgas S, Stavrinoudakis E, Karayiannis D, Balis E. The Correlation of Sit-to-Stand Tests with COPD Assessment Test and GOLD Staging Classification. COPD. 2020 Dec;17(6):655-661. doi: 10.1080/15412555.2020.1825661.)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start20 Feb 2024
- Primary completion19 Sep 2024
- Study completion19 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 521 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark
- Responsible party
- Sponsor
- Investigators
- Anders L. Ottesen, D.M.Sc., Principal investigator, Vejle Hospital, Lillebaelt Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240078
- Sponsor's protocol ID
- COPD and sexual health
- Status last verified
- Jun 2025
- First submitted
- 25 Jan 2024
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan involves sharing anonymized individual participant data (IPD) from this study to enhance scientific transparency and support further research. Excluding any personally identifiable information such as names, CPR numbers, email addresses, or phone numbers, the shared data will encompass anonymized survey responses, demographic details, and aggregated results at the group level. Efforts will be made to publish the data as supplemental materials in scientific articles, contributing to the broader dissemination of research findings.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chronic Obstructive Pulmonary Disease (COPD) on Sexual Health, Loneliness, and Well-being: A Cross-sectional Study of Prevalence and Associated Variables in Individuals With and Without COPD
- ClinicalTrials.gov ID
- NCT06240078
- Acronym / sponsor ID
- COPD and sexual health
- Conditions
- Pulmonary Disease, Chronic Obstructive, Sexual Health, Loneliness, Well-Being, Psychological
- Keywords
- COPD, sexual distress, sexual health, anxiety, depression, loneliness, chronic, associations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 521 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Collaborators
- Region of Southern Denmark
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 2 Feb 2024 (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.
Summary Person-centered care is a hot topic within healthcare, yet communication about patients' sexual health and intimacy issues remain too hot to handle within healthcare. Research indicates that sexual dysfunction and impaired sexual health are frequent among individuals with chronic obstructive pulmonary disease (COPD). Despite patients expecting healthcare professionals to address intimacy issues; these issues are often neglected, since the topic is a taboo.
This study aims to address a gap in observational research by investigating the physical, psychological and social aspects of sexual health in both men and women with and without COPD. The primary hypothesis of this survey-based cross-sectional study is that COPD negatively impacts sexual health, leading to increased loneliness, relationship dissatisfaction, anxiety and/or depression, along with decreased health-related quality of life and well-being in patients. The study seeks to identify associations between impaired sexual health and these factors.
By fostering a new understanding of these aspects, this study is essential to promote person-centered communication about sexual health, addressing the often overlooked needs and concerns of individuals with COPD. Ultimately, the study has the potential to improve sexual health and overall well-being among individuals with COPD, contributing to a more person-centered approach in COPD care.
Detailed description
Objectives The primary objectives of this study are to assess whether impaired sexual health is more prevalent in individuals with COPD compared to those without COPD and to explore its impact on well-being and health-related quality of life. Additionally, the study aims to comprehend the impact of COPD on sexual health by investigating potential associations among selected physical, psychological, and social factors related to sexual health. This understanding is crucial for guiding future studies on identified associations.
The study will examine the following assumptions:
- Impaired sexual health, characterized by a higher prevalence of sexual dysfunction, dissatisfaction, and distress, is more frequent in individuals with COPD than in a control group (individuals without COPD, matched by age, gender, and relationship status).
- COPD has a comprehensive impact on both physical, psychological, and social aspects of sexual health. Impaired sexual health is associated with increased loneliness, relationship dissatisfaction, anxiety and/or depression, as well as decreased health-related quality of life and overall well-being.
Method and materials This study adopts a cross-sectional design, utilizing a patient-reported questionnaire to collect data. The participant pool will encompass individuals aged 40 years or older, including those with COPD and a control group without COPD. The control group will be matched to the COPD sample based on age, gender, and relationship status, enhancing the precision of the exploration of COPD-specific challenges. All participants will be invited to complete a public online questionnaire, with all participants providing electronic informed consent before survey completion.
To explore the impact of COPD on sexual health, including COPD-specific factors, and to assess the perceived effect on quality of life, the questionnaire incorporates various validated instruments. Each instrument will measure a specific aspects related to the physical, psychological, or social dimension of sexual health. Sexual dysfunction and sexual health will be assessed using The PROMIS Sexual Function and Satisfaction Measures (Brief Profile), while emotions and concerns related to sexuality will be identified through The Sexual Distress Scale. Relationship dissatisfaction will be assessed using The Couples Satisfaction Index, loneliness through the UCLA Loneliness Scale, and anxiety/depression via the Hospital Anxiety and Depression Scale. Well-being will be evaluated using the EQ-5D-5L. Individuals with COPD will provide additional insights into the impact of COPD on health through the COPD Assessment Test.
Based on a power calculation (two-sided; p<0.05; power=95%) (26), the study's exploratory approach, and the number of variables, a sample size of minimum 200 participants per group is deemed sufficient to identify associations.
Descriptive statistics, including means, standard deviations, and frequencies, will be employed to report the prevalence of sexual health and summarize data related to COPD-specific challenges. Correlation coefficients will be calculated, and multiple regression analyses will be conducted to identify associations between variables, adjusting for potential confounders. STATA will be used for data analysis. The study results will be reported in accordance with the STROBE guidelines (22).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD group | – | –COPD group: Participants with self-reported COPD (Group 1) |
| Non-COPD group | – | –Non-COPD group: Participants without self-reported COPD, but with other chronic diseases. A comparison group (Group 2) |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include individuals aged 40 years or older, encompassing both men and women. The primary focus will be on individuals diagnosed with Chronic Obstructive Pulmonary Disease (COPD), recruited from relevant websites and social media, primarily through the Danish Lung Association platform (www.lungeforeningen.dk). Additionally, a COPD-free control group, controled by age, sex, and relationship status, will serve as a reference group. This comparison group plays a crucial role in identifying COPD-specific challenges. Most non-COPD individuals will be recruited via the 'Aeldresagen.dk' platform. All participants must be capable and willing to complete a public online questionnaire. The study's diverse demographic ensures a comprehensive exploration of COPD-related factors.
Key inclusion criteria (10 listed)
- COPD Population
- Mild to very servere COPD
- ≥40 years old
- Living in Denmark
- Consent to participate the online survey
Key exclusion criteria (7 listed)
- Unwilling to participate and complete the online survey
- Inability to participate and answer the survey questions in Danish due to cognitive impairment, servere illness, or reading or language barriers
- COPD
- Unwilling to participate and complete the online survey
- Inability to participate and answer the survey questions in Danish due to cognitive impairment, servere illness, or reading or language barriers
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
Sexual health acording to The PROMIS Sex FS BF (vers. 2.0)
Time frame: Day 1
The PROMIS® Sexual Function and Satisfaction Measures, version 2.0. Brief Profile (PROMIS SexFS BF v2.0) universally assesses Sexual Function and Satisfaction. A general screener item inquires about sexual activity in the past 30 days. Respondents who have been sexually active answer items covering various domain, e.g. Interest in Sexual Activity, Satisfaction with Sex Life, Orgasm Ability and Pleasure, Erectile Function, Vaginal Discomfort and Lubrication. Most items are gender-nonspecific. Higher scores indicate greater Interest, Satisfaction, Orgasm ability, etc. Each domain's summed raw score is converted to T-scores, standardized to the U.S. general population (mean 50, SD 10). A clinically meaningful cutoff is five points below the population mean. (Weinfurt KP et al. J Sex Med. 2015;12:1961-1974.).
6 secondary outcomes
Loneliness according to The UCLA Loneliness Scale
Time frame: Day 1
Well-being according to EQ-5D-5L Health related quality of life according to the EQ-5D-5L
Time frame: Day 1
Anxiety and depression according to HADS
Time frame: Day 1
Relationship satisfaction according to The Couples Satisfaction Index
Time frame: Day 1
Sexual distress according to The Sexual Distress Scale
Time frame: Day 1
COPD-impact on health according to CAT
Time frame: Day 1
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 24 Jun 2025.
- Individual participant dataSharing planned: Undecided. The plan involves sharing anonymized individual participant data (IPD) from this study to enhance scientific transparency and support further research. Excluding any personally identifiable information such as names, CPR numbers, email addresses, or phone numbers, the shared data will encompass anonymized survey responses, demographic details, and aggregated results at the group level. Efforts will be made to publish the data as supplemental materials in scientific articles, contributing to the broader dissemination of research findings.
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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.
Anders L. Ottesen, D.M.Sc. principal investigator
Vejle Hospital, Lillebaelt Hospital
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 Pulmonary Disease, Chronic Obstructive and Sexual Health, run by Vejle Hospital at 1 site in Denmark.
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 10 inclusion and 7 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 24 Jun 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 Denmark. 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?
Sexual health acording to The PROMIS Sex FS BF (vers. 2.0) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2025.