Skip to main content
OpenTrials
Completed

NCT Number: NCT02229721

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Female Sexual Dysfunction

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

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

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Syntocinon Nasalspray

Drug

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

Placebo Nasalspray

Drug

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.

Primary outcomes

  1. Female Sexual Function

    Time frame: 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 outcomes

  1. Hamilton Depression Scale (HDS)

    Time frame: 22 weeks

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • Leadiant Biosciences, Inc.

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 1, 2014
Registry last updated
Sep 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.