EUCTR2011-001310-34-AT进行中（未招募）不适用
Female Sexual Dysfunction in the Peri and Postmenopause: Effect of intranasal Oxytocin administration on sexual function and activity - OXY-COUP-PROT1.4
Med. Univ. Wien, Univ. Klinik für Innere Med. III0 个研究点目标入组 60 人开始时间: 2011年7月22日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
- •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
- •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
- •systolic blood pressure >170 or <90 mm Hg or diastolic blood
- •pressure >100 or <50 mm Hg at screening (if stress is suspected,
- 另有 10 项未显示
研究者
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