Sexual behaviour with reduced intercourse frequency due to female sexual function disorders
Conditions
Interventions
Trade Name: Syntocinon spray
Pharmaceutical Form: Nasal spray, solution
CAS Number: 50-56-6
Concentration unit: IU international unit(s)
Concentration type: up to
Concentration number: 40 I.E/ ml-
Pha
Sponsors
Med. Univ. Wien, Univ. Klinik für Innere Med. III
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Females with hypoactive sexual desire, arousal or orgasmic disorders as assed by FSFI =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of intranasal Oxytocin administration on female sexuality;Secondary Objective: • Female Sexual Distress Scale (FSDS) • International Index of Erectile Function (IIEF-5) • Partner Performance Questionnaire (PPQ) • Maximum urinary flow (men) • Oxytocin, Prolactine, Progesterone, Estradiol, • FSH, early morning Cortisol, LH, Vasopressin, free Testosterone, total testosterone, SHBG, DHEA • Blood pressure and blood osmolarity (women);Primary end point(s): Female Sexual Function Index (FSFI) total score Sexual Activity Record (SAR);Timepoint(s) of evaluation of this end point: FSFI: week 1, 5, 8, 12, 18, 22 SAR: week 5, 8, 12, 18, 22 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Female Sexual Distress Scale (FSDS) • International Index of Erectile Function (IIEF-5) • Partner Performance Questionnaire (PPQ) • Sexual life quality questionnaire (SLQQ) • Maximum urinary flow (men) • Oxytocin, Dopamine, Prolactine, Progesterone, Estradiol, • FSH, early morning Cortisol, LH, Vasopressin, free Testosterone, total testosterone, SHBG, DHEA • Blood pressure and blood osmolarity (women) Primary Endpoint Improvement of the FSFI total score and SAR score by 5 % Evaluation of safety and efficiency parameters Adverse reactions will be assessed by collecting the patients diary every 2 to 4 weeks, before the 1st study day females will be trained to use the Syntocinon® Spray and will stay at the ward for 1 hour to asses possible adverse reactions FSFI, SAR, SLQQ, IIEF, PPQ questionnaires will be distributed and collected every 4 to 8 weeks;Timepoint(s) of evaluation of this end point: week 1, 5, 8, 12, 18, 22, 26 | — |
Countries
Austria
Contacts
Public ContactProf. M. Bayerle-Eder
Med. Univ. Wien
Outcome results
None listed