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

NCT02229721 | Completed Phase 2 DMC

• 1 other identifier: 2011-001310-34
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Female Sexual Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Hamilton Depression Scale (HDS)

  22 weeks

Study Arms (2)

Syntocinon Nasalspray 32 IU

ACTIVE COMPARATOR

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; Drug: Placebo Nasalspray

Placebo Nasalspray

PLACEBO COMPARATOR

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; Drug: Placebo Nasalspray

Interventions

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.

Also known as: Oxytocin

Placebo Nasalspray; Syntocinon Nasalspray 32 IU

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.

Placebo Nasalspray; Syntocinon Nasalspray 32 IU

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead
• Leadiant Biosciences, Inc.: collaborator

Study Sites (1)

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

Vienna, Vienna, 1090, Austria

Location

Related Publications (2)

• 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.

  PMID: 28189292 DERIVED

• 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.

  PMID: 26151620 DERIVED

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ. Prof. Michaela Bayerle-Eder

Study Record Dates

• First Submitted: August 27, 2014
• First Posted: September 1, 2014
• Study Start: June 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: September 1, 2014

Record last verified: 2014-08

Locations

AU (1)