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

Medical University of Vienna

Status and phase: Completed; Phase 2

Conditions: Female Sexual Dysfunction

Treatments: Drug: Placebo Nasalspray; Drug: Syntocinon Nasalspray

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02229721

2011-001310-34

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Syntocinon Nasalspray 32 IU

Active Comparator group

Description:

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.

Treatment:

Drug: Syntocinon Nasalspray

Drug: Placebo Nasalspray

Placebo Nasalspray

Placebo Comparator group

Description:

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.

Treatment:

Drug: Syntocinon Nasalspray

Drug: Placebo Nasalspray