Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT06237166
Eligibility Criteria:
Inclusion Criteria:
* female sex
* female gender
* age ≥ 18 years
* diagnosis of sexual dysfunction (ICD-11: HA00, HA01, HA02) or sexual pain disorder (ICD-11: HA20), diagnosed via the DISEX-F interview
* Sexual function score (cut-off) of \<27 on the FSFI
* consent to participation
* sufficient knowledge of the German language
Exclusion Criteria:
* Use of another digital intervention for sexual problems
In general, given that sexual dysfunction is a biopsychosocial phenomenon, mylovia is hypothesized to help women irrespective of the disorder's etiology (i.e., biological, psychological, or social). However, if one of the domains is extremely compromised, mylovia might not be expedient. Therefore, a clinical assessment of factors that might interfere with study assessment will be conducted, with the following additional exclusion criteria:
* Biological factors that might interfere with study participation (e.g., cancer, multiple sclerosis)
* Psychological factors that might interfere with study participation (e.g., schizophrenia, bipolar disorder, borderline personality disorder, eating disorder, post-traumatic stress disorder, severe depression, suicidality, substance use disorder)
* Social factors that might interfere with study participation (e.g. severe partnership problems)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06237166
Study Brief:
Protocol Section:
NCT06237166