Status:
COMPLETED
Effect of Chronic Intranasal Oxytocin Administration on Sexual Function in Pre- and Postmenopausal Women
Lead Sponsor:
Medical University of Vienna
Collaborating Sponsors:
Leadiant Biosciences, Inc.
Conditions:
Female Sexual Dysfunction
Eligibility:
FEMALE
40-70 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02229721
Start Date
June 1 2012
End Date
October 1 2013
Last Update
September 1 2014
Active Locations (1)
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1
Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
Vienna, Vienna, Austria, 1090