Trials / Completed
CompletedNCT06237166
Evaluation of an Online Intervention for Female Sexual Dysfunction
Evaluation of an Online Intervention for Female Sexual Dysfunction: Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 252 (actual)
- Sponsor
- Gaia AG · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | mylovia | Participants will receive access to the digital health intervention mylovia in addition to TAU. |
Timeline
- Start date
- 2024-05-28
- Primary completion
- 2025-02-10
- Completion
- 2025-05-08
- First posted
- 2024-02-01
- Last updated
- 2025-08-22
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT06237166. Inclusion in this directory is not an endorsement.