- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06253403
Sexual Dysfunction and Anorexia Nervosa (SD&MA)
February 10, 2024 updated by: Tatiana Hess, Comenius University
Exploring Sexual Dysfunction in Women Affected by Anorexia Nervosa: Initial Insights
The objective of this observational study is to investigate the potential influence of anorexia nervosa on the sexual health of women.
The primary focus is to determine the presence of sexual dysfunction in individuals with anorexia nervosa and explore any potential correlation between eating disorders and sexual dysfunction.
To facilitate comparison, data from a control group comprising healthy women is incorporated alongside the clinical group data.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
numerous studies indicate that women diagnosed with anorexia nervosa experience a discernible impact on their sexual well-being, often accompanied by symptoms of sexual dysfunction (SD).
Such dysfunction may manifest as a diminished libido, reduced sexual desire, and challenges in achieving orgasm
Study Type
Observational
Enrollment (Actual)
89
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bratislava, Slovakia
- Tatiana Hess
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The subjects within the clinical group are women diagnosed with either AN or a history of anorexia nervosa
Description
Inclusion Criteria:
clinic group :
- adult
- women
- diagnosis of anorexia nervosa
- from Slovakia and Czech Republic
control group:
- health women
- adult
- from Slovakia and Czech Republic
Exclusion Criteria:
clinic group:
- health women
- other diagnosis or disorder
- other country
control group:
- presence of some mental illness
- other country
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
clinic
adult women with anorexia nervosa or actual or after stabilization
|
psychotherapy related to sexual intervention
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control
health adult women without any psychological or mental illnes
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Female Sexual function index (FSFI)
Time Frame: 1 day
|
A self-administered questionnaire was utilized to gather information on participants' sexual experiences and satisfaction over the past four weeks.
The questionnaire encompasses six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain, each rated on a scale of 0 to 5. A lower score indicates a higher likelihood of sexual dysfunction.The maximum attainable score is 36 and minimum is 2, with a cut off of 26 serving as a potential diagnostic threshold for sexual dysfunction
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1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Eating Disorder Examination - Questionnaire Short (EDE-QS
Time Frame: 1 day
|
The Eating Disorder Examination - Questionnaire Short (EDE-QS) is a concise 12-item version featuring a 4-point response scale.
The maximum attainable score is 36 and minimum is 0, with a cut off of 15 serving as a potential diagnostic threshold for eating disorder.
Higher score indicate worse outcome.This instrument is designed to assess eating disorder (ED) symptoms observed within the preceding 7 days.
The screening EDE-QS aims to efficiently identify probable ED symptomatology while demonstrating robust psychometric properties.
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1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Major Dates
Study Start (Actual)
May 15, 2023
Primary Completion (Actual)
January 31, 2024
Study Completion (Estimated)
February 1, 2026
Study Registration Dates
First Submitted
February 2, 2024
First Submitted That Met QC Criteria
February 2, 2024
First Posted (Actual)
February 12, 2024
Study Record Updates
Last Update Posted (Estimated)
February 13, 2024
Last Update Submitted That Met QC Criteria
February 10, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- study1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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The Miriam HospitalUnknownEating Disorders in Adolescence | Anorexia Nervosa/Bulimia | Anorexia Nervosa Restricting TypeUnited States
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