@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 Dysfunctio
Completed
- Conditions
- Female Sexual Dysfunction (FSD), Hypoactive Sexual Desire Disorder, Female Sexual Arousal Disorder, FSD
- Registration Number
- NL-OMON28613
- Lead Sponsor
- Emotional Brain
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
For inclusion in the study, the subjects of the study group healthy women with Female Sexual Dysfunction must fulfil the following criteria:
1. Provision of written informed consent.
Exclusion Criteria
1. Use of oral contraception containing anti-androgens (Like Diane 35 or Minerva).
2. Use of oral contraception containing 50 μg estrogen or more.
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 with Female Sexual Dysfunction.
- 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. <br /><br>2. To investigate differences in attentional bias for erotic stimuli in different subgroups of women with 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>