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Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT02229721 (opens ClinicalTrials.gov in a new tab)Other id2011-001310-34
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
30 participants (actual)
Sponsor
Medical University of Vienna · Other
Design
Randomized · Double masking
Countries
1 country

Austria

Start
Jun 2012
Primary completion
Oct 2013
Completion
Oct 2013
First posted
1 Sept 2014 (estimated)
Last update posted
1 Sept 2014 (estimated)
Conditions
Female Sexual Dysfunction

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201220132014
  1. Ph 2

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

    NCT02229721

    Jun 2012 to Oct 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Syntocinon NasalsprayDrug
  • Placebo NasalsprayDrug

Arms2

  • 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.

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Female Sexual Function

    Time frame · 22 weeks

    Registry description

    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)

  1. Hamilton Depression Scale (HDS)

    Time frame · 22 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2017

6 results

Men's sexual response to female partner's intranasal oxytocin administration for hypoactive sexual desire disorder: an open prospective cohort study.

Muin et al. 2017Fertility and sterilitycited by 7

PMID 28189292DOI 10.1016/j.fertnstert.2016.12.003PUB-28189292

Full text at the publisher6 results
Publisher pageSee results (6)

Indexing hint: Randomized controlled trial · 2015

4 results

Effect of long-term intranasal oxytocin on sexual dysfunction in premenopausal and postmenopausal women: a randomized trial.

Muin et al. 2015Fertility and sterilitycited by 30

PMID 26151620DOI 10.1016/j.fertnstert.2015.06.010PUB-26151620

Full text at the publisher4 results
Publisher pageSee results (4)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 40 Years up to 70 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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