Effect of Chronic Intranasal Oxytocin Administration on Sexual Function in Pre- and Postmenopausal Women
NCT ID: NCT02229721
Last Updated: 2014-09-01
Study Results
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Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2012-06-30
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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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.
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.
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
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
70 Years
FEMALE
Yes
Sponsors
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Leadiant Biosciences, Inc.
INDUSTRY
Medical University of Vienna
OTHER
Responsible Party
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Dana Muin
Univ. Prof. Michaela Bayerle-Eder
Locations
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Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
Vienna, Vienna, Austria
Countries
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References
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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.
Other Identifiers
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2011-001310-34
Identifier Type: -
Identifier Source: org_study_id
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