Female Sexual Dysfunction
Conditions
Brief summary
The purpose of this study is to determine whether intranasal oxytocin is effective in comparison to placebo in improving female sexual dysfunction in pre- and postmenopausal women.
Interventions
DRUGSyntocinon Nasalspray
Over 8 weeks, intranasal oxytocin (32 IE) or placebo will be self-administered by women prior to sexual intercourse. Following a washout period of 2 weeks, a cross-over will take place and patients switched to the alternate group for another 8 weeks. The recommended dose is four puffs per nostril, containing 32 IU of synthetic oxytocin, administered up to 50 minutes prior to sexual activity. The maximal dose should not exceed four puffs per nostril per day; the minimum dose was twice weekly.
Over 8 weeks, intranasal oxytocin (32 IE) or placebo will be self-administered by women prior to sexual intercourse. Following a washout period of 2 weeks, a cross-over will take place and patients switched to the alternate group for another 8 weeks. The recommended dose is four puffs per nostril, administered up to 50 minutes prior to sexual activity. The maximal dose should not exceed four puffs per nostril per day; the minimum dose was twice weekly.
Sponsors
Leadiant Biosciences, Inc.
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Willingness to attempt sexual intercourse and/ or masturbation at least two times per week * Ongoing relationship for at least 3 months * Female subjects aging 40 years and more, Male subjects must be older than 18 * The participation in this study should be of free choice to male partners * Willingness to perform a pregnancy test every month (for pre-menopausal subjects) * Willingness to use contraception during the study period (for pre-menopausal subjects) * Normal findings in the urogenital tract unless the investigator considers an abnormality to be clinically irrelevant * Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant * Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Exclusion criteria
* Primary sexual dysfunction * sexual abuse * severe psychiatric diseases * untreated conditions and medication intake with associated reduction of sexual function. * In male partners: any severe andrological or related medical problem.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Female Sexual Function | 22 weeks | Assessment by standardized questionnaires including Female Sexual Function Index (FSFI), Female Sexual Distress Scale (FSDS), Sexual Quality of Life-Female (SQOL-F), Sexual Activity Record (SAR), and Sexual Interest and Desire Inventory-Female (SIDI-F). |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale (HDS) | 22 weeks |
Countries
Austria
Outcome results
None listed