Female Sexual DysfunctionFELYCIANCT06237166
Evaluation of an Online Intervention for Female Sexual Dysfunction
A study testing mylovia in people with Female Sexual Dysfunction, run by Gaia AG at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Sexual Dysfunction
- What is being tested?
- mylovia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteGermany
- Study dates
- 28 May 2024to 8 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of an Online Intervention for Female Sexual Dysfunction: Randomized Controlled Trial
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
- Being tested
- mylovia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myloviaBehavioural
Participants will receive access to the digital health intervention mylovia in addition to TAU.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
sexual functioning
Female Sexual Function Index (FSFI). Total score ranging from 2-36; higher scores mean better sexual function (better outcome).
Measured: 3 months
Secondary outcomes (4)
Depressive symptoms
Patient Health Questionnaire - 9 item version (PHQ-9). Total score ranging from 0-27; higher scores mean more depressive symptomatology (worse outcome).
Measured: 3 months, 6 months
Sexual desire
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).
Measured: 3 months, 6 months
Sexual satisfaction
New Sexual Satisfaction Scale - Short Form (NSS-SF). Total score ranging from 12 to 60; higher scores mean higher sexual satisfaction.
Measured: 3 months, 6 months
Sexual functioning
Female Sexual Function Index (FSFI). Total score ranging from 2-36; higher scores mean better sexual function (better outcome).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start28 May 2024
- Primary completion10 Feb 2025
- Study completion8 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Female Sexual DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaia AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical School Hamburg
- Responsible party
- Sponsor
- Investigators
- Johanna Schröder, PhD, Principal investigator, Medical School Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237166
- Sponsor's protocol ID
- mylovia RCT
- Acronym
- FELYCIA
- Status last verified
- Aug 2025
- First submitted
- 24 Jan 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41634129
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Online Intervention for Female Sexual Dysfunction: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06237166
- Acronym / sponsor ID
- FELYCIA / mylovia RCT
- Conditions
- Female Sexual Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Gaia AGIndustry (pharma, biotech, devices)
- Collaborators
- Medical School Hamburg
- Study start
- 28 May 2024 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 8 May 2025 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mylovia + TAU | Experimental | Behavioral: myloviaParticipants 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. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| myloviaParticipants will receive access to the digital health intervention mylovia in addition to TAU. | Behavioural | mylovia + TAU |
Primary outcome
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).
4 secondary outcomes
Depressive symptoms
Time frame: 3 months, 6 months
Sexual desire
Time frame: 3 months, 6 months
Sexual satisfaction
Time frame: 3 months, 6 months
Sexual functioning
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Derived from this study: PubMed 41634129Blaszcyk 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johanna Schröder, PhD principal investigator
Medical School Hamburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mylovia in people with Female Sexual Dysfunction, run by Gaia AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sexual functioning (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06237166, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.