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Evaluation of an Online Intervention for Female Sexual Dysfunction

NCT06237166 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2025-08-22

No results posted yet for this study

Summary

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.

Conditions

  • Female Sexual Dysfunction

Interventions

BEHAVIORAL

mylovia

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

Sponsors & Collaborators

  • Medical School Hamburg

    collaborator OTHER

  • Gaia AG

    lead INDUSTRY

Principal Investigators

  • Johanna Schröder, PhD · Medical School Hamburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-28
Primary Completion
2025-02-10
Completion
2025-05-08

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06237166 on ClinicalTrials.gov