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

Female Sexual Dysfunction Clinical Trial

Official title:

Female Sexual Dysfunction in the Menopause: Effect of Intranasal Oxytocin Administration on Sexual Function and Activity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02229721
• Other study ID #: 2011-001310-34
• Status: Completed
• Phase: Phase 2
• First received: August 27, 2014
• Last updated: August 28, 2014
• Start date: June 2012
• Est. completion date: October 2013

Study information

• Verified date: August 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Female Sexual Dysfunction

Intervention

Drug:
• Syntocinon 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.
• Placebo 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, 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.

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	Sigma Tau Pharmaceuticals, Inc.

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Female Sexual Function	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).	22 weeks	No
Secondary	Hamilton Depression Scale (HDS)		22 weeks	No