NL-OMON36064已完成2 期
A double-blind, randomized, placebo-controlled, proof of concept study to investigate the safety and efficacy of the combined administration of 0.5 mg sublingual testosterone and 10 mg tadalafil in women with hypoactive sexual desire disorder - Tadalafil Proof of Concept
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1.Provision of written informed consent
- •2.Female 21 to 45 years of age, inclusive, premenopausal, with HSDD (comorbidity with female sexual arousal disorder and/or female orgasmic disorder [FOD; only as secondary diagnosis] is allowed). The diagnosis of HSDD will be established by a trained professional.
- •3.Heterosexual orientation
- •4.Be involved in a stable relationship
- •5.Healthy according to normal results of medical history, physical examination, laboratory values, and vital signs; exceptions may be made if the investigator considers an abnormality to be clinically irrelevant
排除标准
- •Cardiovascular Conditions
- •1.Any underlying cardiovascular condition, including unstable angina pectoris, that would preclude sexual activity
- •2.History of myocardial infarction, stroke, transient ischemic attack or life threatening arrhythmia within the prior 6 months
- •3.Uncontrolled atrial fibrillation/flutter at screening or other significant abnormality observed on electrocardiogram (ECG)
- •4.Systolic blood pressure >= 140 mmHg and/or diastolic blood pressure > 90 mmHg
- •5.Systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 50 mmHg;Gynecological and Obstetric Conditions
- •6.Use of oral contraceptive containing anti androgens
- •7.Use of oral contraceptive containing 50 µg estrogen or more
- •8.Pregnancy or intention to become pregnant during this study (Note: A urine pregnancy test will be performed in all women prior to the administration of study medications.)
- •9.Lactating or delivery in the previous 6 months
- •10.Significant abnormal pap smear in the previous 12 months
- •11.History of bilateral oophorectomy
- •12.Other unexplained gynecological complaints, such as clinically relevant abnormal uterine bleeding patterns;Other Medical Conditions
- •13.Liver and/or renal insufficiency (aspartate aminotransferase and alanine aminotransferase > 3 times the upper limit of normal and/or glomerular filtration rate < 29 mL/min based on the Cockcroft and Gault formula)
- •14.Current clinically relevant endocrine disease or uncontrolled diabetes mellitus
- •15.Current clinically relevant neurological disease which, in the opinion of the investigator, would compromise the validity of study results, or which could form a contraindication for tadalafil and/or testosterone use
- •16.History of hormone dependent malignancy
- •17.Vision impairment, such as partial or complete blindness or color blindness
- •18.Dyslexia
- •19.Positive test result for human immunodeficiency virus, hepatitis B, or hepatitis C (acute and chronic hepatitis infection);Psychological/Psychiatric Factors
- •20.History of (childhood) sexual abuse that, in the opinion of the investigator, could have negative psychological effects when testosterone is administered
- •21.Treatment for a psychiatric disorder that, in the opinion of the investigator, would compromise the validity of study results or which could be a contraindication for tadalafil and/or testosterone use
- •22.Current psychotherapeutic treatment for female sexual dysfunction
- •23.Current sexual disorder of vaginismus or dyspareunia according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (text revision).
- •24.A substance abuse disorder that, in the opinion of the investigator, is likely to affect the subject's ability to complete the study or precludes the subject*s participation in the study.
- •25.Positive test result for illicit drugs;Concomitant Medications
- •26.Use of potent CYP3A4 inhibitors (eg, ritonavir, ketoconazol, itraconazol claritromycine, erytromycine, saquinavir and grapefruitjuice)
- •27.Use of potent CYP3A4 inducers (eg, carbamazepine, phenytoin, phenobarbital, St Johns Wort, rifampicin)
- •28.Use of nitrates or nitric oxide donor compounds
- •29.Use of SSRIs
- •30.Use of any other medication that interferes with study medication (eg, monoamine oxidase [MAO] inhibitors [includes classic MAO inhibitors and linezolid)
- •31.Use of medication (including herbs) that would compromise the validity of study
研究者
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