Intranasal Oxytocin administration on sexual function and activity

• Conditions: Sexual behaviour with reduced intercourse frequency due to female sexual function disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2011-001310-34-AT
• Lead Sponsor: Med. Univ. Wien, Univ. Klinik für Innere Med. III

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-22
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Females with hypoactive sexual desire, arousal or orgasmic
disorders as assed by FSFI <27
• Willingness to perfrom a pregnancy test every month for premenopausal women
Willingness to use contraception during the study period for premenopausal women

• Ongoing sexual active relationship for at least 3 months
• Female subjects must be older tha 40 years
• Male subjects must be older than 18
• 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
• Willingness to attempt sexual intercourse and/ or masturbation
at least two times per week
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

• Abuse of alcoholic beverages or drugs, participation in a
clinical trial during 3 weeks preceding the study
• Symptoms of a clinically relevant illness during 3 weeks
before the first study day
• Presence of hepatic or renal dysfunction
• Patients with known hypersensitivity to the study drug or any
ingredients
• Blood or plasma donation during the previous 3 weeks
• Any sexual pain conditions
• Smoking > 10 cigarettes a day
• BMI < 18 and > 35 kg/m2

Exclusion Criteria
For females
Pregnancy
• Lifelong, but not acquired, hypoactive sexual disorder
• Chronic sinusitis or recurrent Ear-Nose-Throat infections
• History or presence of cardiovascular disease and untreated
hypertension
• Pelvic or genital diseases
• Recurrent infections of the urogenital tract
• Female genital prolapsed
• History of hysterotomy
• Presence of a major depression or any psychiatric disease
• History of sexual abuse or primary sexual dysfunction

Exclusion Criteria
for males (n=5) with
erectile dysfunction
receiving a PDE 5
inhibitor
• clinically significant renal insufficiency
• clinically significant hepatobiliary disease
• Hemoglobin A1c >13% at Visit 1.
• chronic stable angina treated with long-acting nitrates, or
with chronic stable angina requiring short-acting nitrates in the last
90 days, or with angina occurring during sexual intercourse in the
last 6 months.
• unstable angina 6 months before Visit 1
• history of myocardial infarction or coronary artery bypass graft
surgery within 90 days before Visit 1 or percutaneous coronary
intervention (for example, angioplasty or stent placement) within
90 days before Visit 1.
• supraventricular arrhythmia with an uncontrolled ventricular
response (mean heart rate >100 bpm) at rest, or have any history of
spontaneous or induced sustained ventricular tachycardia (heart
rate >100 bpm for !30 sec), or use an automatic internal
cardioverterdefibrillator.
• history of sudden cardiac arrest.
evidence of congestive heart failure (NYHA Class 2 or
above) within 6 months before Visit 1.
• new, significant cardiac conduction defect within 90 days before
Visit 1.
• systolic blood pressure >170 or <90 mm Hg or diastolic blood
pressure >100 or <50 mm Hg at screening (if stress is suspected,
retest under basal conditions), or have history of malignant
hypertension.
• history of significant central nervous system injuries (including
stroke or spinal cord injury) within the last 6 months.
• history of Human Immunodeficiency Virus (HIV) infection.
• inability to provide informed consent or uncompliance
• current treatment with nitrates, cancer chemotherapy, or
antiandrogens [except finasteride taken as Proscar2, or Avodart2!
(dutasteride)]
• history of drug, alcohol, or substance abuse within the past 6
months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of intranasal Oxytocin administration on female sexuality;Secondary Objective: •Female Sexual Distress Scale (FSDS)<br>•International Index of Erectile Function (IIEF-5)<br>•Partner Performance Questionnaire (PPQ)<br>•Maximum urinary flow (men)<br>•Oxytocin,Prolactine, Progesterone, Estradiol,<br>• FSH, early morning Cortisol, LH, Vasopressin, free Testosterone, total testosterone, SHBG, DHEA<br>•Blood pressure and blood osmolarity (women);Primary end point(s): Female Sexual Function Index (FSFI) total score<br>Sexual Activity Record (SAR);Timepoint(s) of evaluation of this end point: FSFI: week 1, 5, 8, 12, 18, 22<br>SAR: week 5, 8, 12, 18, 22

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Female Sexual Distress Scale (FSDS)<br>• International Index of Erectile Function (IIEF-5)<br>• Partner Performance Questionnaire (PPQ)<br>• Sexual life quality questionnaire (SLQQ)<br>• Maximum urinary flow (men)<br>• Oxytocin, Dopamine, Prolactine, Progesterone,<br>Estradiol,<br>• FSH, early morning Cortisol, LH, Vasopressin, free<br>Testosterone, total testosterone, SHBG, DHEA<br>• Blood pressure and blood osmolarity (women)<br>Primary Endpoint Improvement of the FSFI total score and SAR score by 5 %<br>Evaluation of safety<br>and<br>efficiency parameters<br>Adverse reactions will be assessed by collecting the patients<br>diary every 2 to 4 weeks, before the 1st study day females<br>will be trained to use the Syntocinon® Spray and will stay<br>at the ward for 1 hour to asses possible adverse reactions<br>FSFI, SAR, SLQQ, IIEF, PPQ questionnaires will be<br>distributed and collected every 4 to 8 weeks;Timepoint(s) of evaluation of this end point: week 1, 5, 8, 12, 18, 22, 26