@home: a study to investigate the subjective and physiological efficacy and safety of Lybrido and Lybridos in the domestic setting in healthy female subjects with Female Sexual Dysfunction and SSRI usage.
Completed
- Conditions
- Female Sexual Dysfunction (FSD), Substance induced Sexual Dysfunction, SSRI induced sexual dysfunction, Hypoactive Sexual Desire Disorder (HSDD), Female Sexual Arousal Disorder (FSAD)
- Registration Number
- NL-OMON22992
- Lead Sponsor
- Emotional Brain BV
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
For inclusion in the study, heterosexual women (pre-, and postmenopausal) with Hypoactive Sexual Desire Disorder (HSDD) in combination with SSRI use must fulfil the following criteria:
Exclusion Criteria
- Any of the following is regarded as a criterion for exclusion from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate efficacy of Lybrido and Lybridos on subjective sexual experience in the domestic setting in healthy female subjects Female Sexual Dysfunction using SSRIs.
- Secondary Outcome Measures
Name Time Method 1. To evaluate efficacy of Lybrido and Lybridos on physiological sexual responding (vaginal and clitoral) in the domestic setting in different subgroups of women with FSD in combination with SSRI use.<br /><br>2. To investigate differences in attentional bias for erotic stimuli in different subgroups of women with FSD and SSRI induced FSD, and the influence of Lybrido and Lybridos herein.<br /><br>3. To investigate differences in subjective, physiological and neuropsychological responding at home or in the laboratory.<br /><br>4. To evaluate the safety of Lybrido and Lybridos in the domestic setting.<br>