Evaluation of an Online Intervention for Female Sexual Dysfunction

NCT06237166 | Completed

• 1 other identifier: mylovia RCT
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• sexual functioning

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

  3 months

Secondary Outcomes (4)

• Depressive symptoms

  3 months, 6 months

• Sexual desire

  3 months, 6 months

• Sexual satisfaction

  3 months, 6 months

• Sexual functioning

  6 months

Other Outcomes (1)

• Cognitions and behaviors related to sexual pain

  3 months, 6 months

Study Arms (2)

mylovia + TAU

EXPERIMENTAL

Participants allocated to the intervention group will receive access to mylovia in addition to treatment as usual (TAU). mylovia is a digital health application designed for women with sexual dysfunction, accessible through a web browser. The application focuses on treatment methods derived from cognitive behavioral therapy (CBT). Topics addressed by mylovia are psychoeducation, relaxation and mindfulness exercises, strategies to improve self-esteem, development of passionate attitudes and situations, dealing with differences in desire in a relationship, and sensate focus exercises. The program operates through interactive "dialogues", which are accompanied by illustrations, audio recordings, motivational text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 180 days.

Behavioral: mylovia

information material + TAU

NO INTERVENTION

Participants allocated to the control group will receive access to information material about treatment and counseling options in addition to treatment as usual (TAU).

Interventions

mylovia BEHAVIORAL

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

mylovia + TAU

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: both female sex and female gender
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Use of another digital intervention for sexual problems
• 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)

Sponsors & Collaborators

• Gaia AG: lead
• Medical School Hamburg: collaborator

Study Sites (1)

GAIA

Hamburg, 22085, Germany

Location

Related Publications (1)

• Blaszcyk W, Buttner M, Betz LT, Riepenhausen A, Jacob GA, Klein JP, Schroder J. Digital intervention mylovia improves sexual functioning in women with sexual dysfunction in randomized controlled trial. NPJ Digit Med. 2026 Feb 3;9(1):115. doi: 10.1038/s41746-026-02385-z.

  PMID: 41634129 DERIVED

Study Officials

• Johanna Schröder, PhD

  Medical School Hamburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 1, 2024
• Study Start: May 28, 2024
• Primary Completion: February 10, 2025
• Study Completion: May 8, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)