Effect of Chronic Intranasal Oxytocin Administration on Sexual Function in Pre- and Postmenopausal Women

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of Vienna
• Collaborators: Leadiant Biosciences, Inc.; Sigma Tau Pharmaceuticals, Inc.
• Treatments: Oxytocin; Polystyrene sulfonic acid

Criteria

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.