- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07752511
Anticipated Stigma, Illness Identity, and Quality of Life in Male Hypogonadism
The Impact of Anticipated Illness Stigma and Illness Identity on Quality of Life in Men With Hypogonadism: A Comparative Study With Other Chronic Endocrine Diseases
Study Overview
Status
Conditions
Detailed Description
Hypogonadism is a chronic endocrine condition characterized by subnormal serum testosterone levels. Unlike other chronic metabolic conditions, hypogonadism directly threatens core attributes of male gender identity, including sexual function, physical capacity, and reproductive potential. While biological manifestations and medical management are well documented, the psychosocial dimensions of hypogonadism, specifically anticipated stigma and illness identity, remain insufficiently explored in clinical research.
Anticipated stigma involves cognitive expectations of negative reactions, judgment, or discrimination from interpersonal, occupational, and healthcare environments. In conditions where illness poses a direct threat to gender role identity, anticipated stigma may be heightened compared to non-identity-threatening chronic conditions such as diabetes or hypertension. Furthermore, the degree to which an individual integrates the diagnosis into their self-concept (illness identity) may interact with anticipated stigma to exacerbate health-related quality-of-life impairments.
This study systematically evaluates anticipated stigma and illness identity in men with hypogonadism in comparison to age-matched controls with other chronic endocrine conditions treated in the same clinical setting. The primary objective is to determine whether anticipated stigma levels differ significantly between these groups and to examine the predictive capacity of anticipated stigma and illness identity on disease-specific symptom burden and quality-of-life outcomes within the hypogonadism cohort.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Bingoel, Turkey (Türkiye)
- Bingöl University Faculty of Physical Therapy and Rehabilitation
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Contact:
- Aybüke Fanuscu, Pt, PhD
- Phone Number: 5548 +904262160012
- Email: afanuscu@bingol.edu.tr
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Malatya, Turkey (Türkiye)
- Malatya Training and Research Hospital
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Contact:
- Emine Şener Aydın, MD
- Phone Number: +904222118019
- Email: dreminesener@windowslive.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Cases:
- Male, aged 18 years or older.
- Biochemically confirmed hypogonadism (total testosterone < 300 ng/dL with at least one clinical symptom).
- Regular follow-up at the endocrinology outpatient clinic.
- Fluent in reading and understanding Turkish.
- Signed informed consent.
Controls:
- Male, aged 18 years or older.
- Diagnosed with diabetes, hypertension, or hypothyroidism under regular endocrinology follow-up.
- Total testosterone ≥ 300 ng/dL.
- Age-matched to a participant in the case group (±5 years).
- Fluent in reading and understanding Turkish.
- Signed informed consent.
Exclusion Criteria:
- Active psychiatric diagnosis (e.g., active psychosis, bipolar disorder).
- Chronic inflammatory or rheumatological diseases affecting body composition (e.g., chronic kidney disease, IBD, rheumatoid arthritis, SLE, ankylosing spondylitis).
- Uncontrolled co-existing endocrine conditions or severe complications (e.g., HbA1c > 8.0%, diabetic neuropathy/nephropathy/retinopathy, non-euthyroid state).
- Cognitive impairment or dementia precluding questionnaire completion.
- Klinefelter syndrome.
- Literacy limitations preventing completion of self-report measures.
- Additional control exclusion: Diagnosis or clinical suspicion of hypogonadism.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Hypogonadism Group (Case)
Male patients aged 18 years or older with biochemically confirmed hypogonadism (total testosterone < 300 ng/dL with at least one clinical symptom) undergoing regular follow-up in the endocrinology clinic.
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Control Group (Other Chronic Endocrine Diseases)
Male patients aged 18 years or older diagnosed with diabetes mellitus, hypertension, or hypothyroidism without hypogonadism (total testosterone ≥ 300 ng/dL), matched by age (±5 years) to the case group and under regular follow-up in the same endocrinology clinic.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Chronic Illness Anticipated Stigma Scale (CIASS) Score
Time Frame: Baseline (Single session, day 1)
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Measures anticipated stigma across three subscales (friends/family, work, healthcare workers) on a 5-point Likert scale.
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Baseline (Single session, day 1)
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Brief Illness Perception Questionnaire (Brief IPQ) Score
Time Frame: Baseline (Single session, day 1)
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Assesses cognitive and emotional representations of illness.
Higher total scores indicate a more threatening illness perception.
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Baseline (Single session, day 1)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Aging Males' Symptoms (AMS) Scale Score
Time Frame: Baseline (Single session, day 1)
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Evaluates the severity of symptoms related to aging/hypogonadism across somatic, psychological, and sexual domains.
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Baseline (Single session, day 1)
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Hospital Anxiety and Depression Scale (HADS) Score
Time Frame: Baseline (Single session, day 1)
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Measures anxiety and depression symptom severity via 14 items (7 anxiety, 7 depression).
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Baseline (Single session, day 1)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AF-202604
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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