Placebo-Controlled Cross-Over Pilot Trial of Natesto Testosterone Nasal Gel on Demand for Hypogonadal Men With Sexual Dysfunction Using Daily Phosphodiesterase-5 Inhibitor
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Comparison of Erectile Function and Sexual Intercourse Satisfaction Total Scores Recorded at Baseline and End of Study.
研究概览
简要总结
To determine if testosterone deficient men who are using daily Tadalafil (a phosphodiesterase-5 Inhibitor), will have a significant improvement in erectile function and satisfaction with erectile dysfunction treatment when using on-demand Testosterone Nasal Gel (TNG) prior to sexual activity compared to placebo.
详细描述
The purpose of this study is to determine if testosterone deficient men whose primary symptom is erectile dysfunction, who are using daily Tadalafil (a phosphodiesterase-5 Inhibitor), will have a significant improvement in erectile function and satisfaction with erectile dysfunction treatment when using on-demand Testosterone Nasal Gel (TNG) prior to sexual activity compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-Blind
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Ability to understand and provide written informed consent for the study.
- •Ability to read and complete electronic questionnaires in English.
- •Adult males between the ages of 18-64 years
- •Mild-moderate ED based on SHIM score between 8-21 at study entry
- •Ability to take daily Tadalafil
- •Ability to undergo venipuncture
- •Ability to provide ejaculated semen sample
- •Stable female sexual partner with sexual activity at least 1-3 times/month
- •Hypogonadism defined as two (one done as SOC within the last 6 months and one done at the time of screening) early morning total testosterone lab values <300
排除标准
- •Morbid Obesity - BMI >35
- •History of Diabetes (HBA1c >6.0)
- •Hematocrit < 35% or > 54% at study entry
- •Concurrent or Prior use of other exogenous testosterone or hormone therapy (SERM, aromatase inhibitor, gonadotropins) within the last 3 months.
- •Concurrent use of other prescription medications for ED including PDE5 inhibitors, intracavernosal injection therapy, urethral suppositories
- •Concurrent use of nitrates in any form
- •History of pelvic radiation
- •Spinal cord injury
- •Any progressive neurologic disease (Alzheimer's, Parkinson's, multiple sclerosis, etc).
- •History of penile prosthesis
- •History of prostatectomy
- •History of transurethral resection of prostate
- •History of stroke or myocardial infarction within the past 6 months
- •History of congestive heart failure
- •History of untreated obstructive sleep apnea
- •History of liver disease (Serum transaminases > 2.5 times upper limit of normal)
- •History of chronic kidney disease (GFR<60 or Serum Cr >2)
- •History of, current or suspected, prostate (abnormal DRE or elevated PSA >4.0) or breast cancer.
- •History of azoospermia or oligospermia (<15 million/ml)
- •History of vasectomy
- •History of Priapism
- •History of Polycythemia Vera
- •Receipt of any investigational product within 4 weeks of study enrollment
- •Recurrent upper respiratory or sinus infection (>3 times/month for >6 months)
- •Recurrent epistaxis (>3 times/month for >6 months)
研究组 & 干预措施
Natesto
Natesto™ is a testosterone nasal gel that is FDA approved to treat low testosterone. It delivers testosterone through the nasal passages and it is then absorbed into the blood stream. The nasal pump is placed at the opening of each nostril and then the participant would press down on the nasal pump to apply the gel. Each application takes about 10 seconds and the nasal pump applies a thin layer of gel that absorbs through the lining of the nose.
干预措施: Natesto Nasal Product (Drug)
Placebo
This study involves a placebo. The placebo will look like the Natesto™ nasal pump and will contain a nasal gel, but without any active ingredients.
干预措施: Placebo (Drug)
结局指标
主要结局
Comparison of Erectile Function and Sexual Intercourse Satisfaction Total Scores Recorded at Baseline and End of Study.
时间窗: At Baseline and at the end of the study (Day 180)
The primary endpoint of the study will be mean change in erectile function and satisfaction with sexual intercourse using the validated SHIM questionnaire. This questionnaire has been used extensively in clinical trials evaluating PDE5i for ED and is also used very commonly in the clinical practice. The SHIM Is a 5 item questionnaire that assesses the ability to get and maintain an erection sufficient for intercourse (Q1-Q4) and Q5 which assesses patient satisfaction. Each question is scored 0 to 5 with a total maximum score of 25. The investigators will look at the answers to all 5 questions and a higher score is interpreted as a better outcome.
次要结局
- Comparison of Sexual Function Scores Recorded at Baseline and End of Study(At Baseline and at the end of the study (Day 180))
- Comparison of Erection Success Recorded at Baseline and End of Study(At Baseline and at the end of the study (Day 180))
- Comparison of Treatment Satisfaction Total Scores at Baseline and End of Study(At Baseline and at the end of the study (Day 180))
- Comparison of Erectile Dysfunction Inventory of Treatment Satisfaction Total Scores at Baseline and End of Study(Baseline and at the end of the study (Day 180))
研究者
Jim Hotaling
Principal Investigator
University of Utah