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OpenTrials
Completed

NCT Number: NCT06237166

Evaluation of an Online Intervention for Female Sexual Dysfunction

In this randomized controlled clinical trial, 250 participants with female sexual dysfunction will be investigated regarding the effectiveness of an online intervention for improving sexual function, the unguided online intervention mylovia. Inclusion criteria are: female sex and female gender, age ≥18, diagnosed sexual dysfunction (ICD-11: HA00, HA01, HA02) or sexual pain disorder (ICD-11: HA20), low sexual functioning (<27 on the Female Sexual Function Index; FSFI), sufficient German skills, and consent to participation. Exclusion criteria are: biological, psychological or social factors that might interfere with study participation, and use of another digital intervention for sexual problems. Participants will be randomized and allocated to either an intervention group, receiving access to mylovia in addition to treatment as usual (TAU), or a control group, receiving information material about treatment and counseling options in addition to TAU. Primary endpoint will be sexual functioning assessed via FSFI, with three months post-allocation being the primary time point for assessment of effectiveness. Six months post allocation will be used as a timepoint for follow-up assessment of endpoints. Secondary endpoints will be sexual desire, sexual satisfaction, sexual pain, and general psychopathology.

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Key information

Conditions

Female Sexual Dysfunction

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

GAIA

Hamburg, 22085, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

mylovia

Behavioral

Participants will receive access to the digital health intervention mylovia in addition to TAU.

Primary outcomes

  1. sexual functioning

    Time frame: 3 months

    Female Sexual Function Index (FSFI). Total score ranging from 2-36; higher scores mean better sexual function (better outcome).

Secondary outcomes

  1. Depressive symptoms

    Time frame: 3 months, 6 months

    Patient Health Questionnaire - 9 item version (PHQ-9). Total score ranging from 0-27; higher scores mean more depressive symptomatology (worse outcome).

  2. Sexual desire

    Time frame: 3 months, 6 months

    Sexual Interest and Desire Inventory - Female - Self-Report (SIDI-F-SR). Total score ranging from 0-51; higher scores mean higher levels of sexual desire (better outcome).

  3. Sexual satisfaction

    Time frame: 3 months, 6 months

    New Sexual Satisfaction Scale - Short Form (NSS-SF). Total score ranging from 12 to 60; higher scores mean higher sexual satisfaction.

  4. Sexual functioning

    Time frame: 6 months

    Female Sexual Function Index (FSFI). Total score ranging from 2-36; higher scores mean better sexual function (better outcome).

Other outcomes

  1. Cognitions and behaviors related to sexual pain

    Time frame: 3 months, 6 months

    Self-compiled instrument assessing cognitions and behaviors related to sexual pain. Total score ranging from 0-100; higher scores mean more maladaptive cognitions and behaviors related to sexual pain (worse outcome).

Sponsors and collaborators

Lead sponsor

Gaia AG

Industry

Collaborators

  • Medical School Hamburg

Registry information

Official study title

Evaluation of an Online Intervention for Female Sexual Dysfunction: Randomized Controlled Trial

Acronym: FELYCIA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 1, 2024
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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