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

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

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.

Study Overview

• Status: Completed
• Conditions: Female Sexual Dysfunction
• Intervention / Treatment: Drug: Syntocinon Nasalspray; Drug: Placebo Nasalspray

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Syntocinon Nasalspray 32 IU; 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.	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.; Other Names: Oxytocin; Drug: 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.
Placebo Comparator: 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.	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.; Other Names: Oxytocin; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Hamilton Depression Scale (HDS)	22 weeks

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: Leadiant Biosciences, Inc.

Publications and helpful links

General Publications

• Muin DA, Sheikh Rezaei S, Tremmel-Scheinost M, Salama M, Luger A, Wolzt M, Husslein PW, Bayerle-Eder M. Men's sexual response to female partner's intranasal oxytocin administration for hypoactive sexual desire disorder: an open prospective cohort study. Fertil Steril. 2017 Mar;107(3):781-787.e3. doi: 10.1016/j.fertnstert.2016.12.003. Epub 2017 Feb 8.
• Muin DA, Wolzt M, Marculescu R, Sheikh Rezaei S, Salama M, Fuchs C, Luger A, Bragagna E, Litschauer B, Bayerle-Eder M. Effect of long-term intranasal oxytocin on sexual dysfunction in premenopausal and postmenopausal women: a randomized trial. Fertil Steril. 2015 Sep;104(3):715-23.e4. doi: 10.1016/j.fertnstert.2015.06.010. Epub 2015 Jul 4.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: August 27, 2014
• First Submitted That Met QC Criteria: August 28, 2014
• First Posted (Estimate): September 1, 2014

Study Record Updates

• Last Update Posted (Estimate): September 1, 2014
• Last Update Submitted That Met QC Criteria: August 28, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: 2011-001310-34