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

Phase 2

Completed

• Conditions: Female Sexual Dysfunction
• Interventions: Drug: Syntocinon Nasalspray; Drug: Placebo Nasalspray

• Registration Number: NCT02229721
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-08
• Study First Submitted: 2014-08-27
• Study First Submitted QC: 2014-08-28
• Last Update Submitted: 2014-08-28
• Study First Posted: 2014-09-01
• Last Update Posted: 2014-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Syntocinon Nasalspray 32 IU	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	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, 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	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.
Syntocinon Nasalspray 32 IU	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, 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Hamilton Depression Scale (HDS)	22 weeks

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria; 🇦🇹 Vienna, Austria