A Double Masked, Randomised, 3-way Cross-over, Single-center, Clinical Investigation to Evaluate the Effectiveness of Two NRL Condoms With Benzocaine Paste Compared With a Standard NRL Control in Prolonging Time to Ejaculation in Healthy Adult Men
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- To determine the effectiveness of the Test Condom A compared with the Control NRL Condom at prolonging time to ejaculation.
研究概览
简要总结
This investigation is designed to evaluate the effectiveness of two NRL condoms with Benzocaine paste compared with a standard NRL control.
详细描述
In this clinical investigation, two NRL condoms with Benzocaine paste (Test condom A and Test condom B) will be evaluated against a standard NRL male condom (Control condom) in prolonging time to ejaculation in healthy adult men.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Each condom will be contained within an individual foil packet on which all branding will be masked. All the condom types will be masked in the same manner and identical secondary packaging boxes will be used.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects and their female partners between the ages of >=18 years and =<60 years.
- •Subjects and their female partners must have no health condition in their medical history.
- •Subject must be sexually active having regular intercourse (a minimum frequency of once a week).
- •Subjects in a stable, monogamous, sexual relationship with the same female partner for more than or equal to 3 months.
- •Subject's female partner should already be on an established other highly effective form of non-barrier contraception, unless post-menopausal.
排除标准
- •Subject or his female partner with alcohol or drug abuse.
- •Subjects and their female partners with anemia, coronary artery disease, impaired cardiac conduction, pulmonary disease, diabetes, and renal or hepatic disease.
- •Subjects and their female partners with a risk of methaemoglobinemia / complications related to ester anaesthetics which could trigger methemoglobinemia.
- •Subject and/or his female partner with urological disease or genitourinary surgery; ongoing significant psychiatric disorder not controlled by medication; history of surgery or injury to the pelvis, retroperitoneal surgery, radiotherapy, multiple sclerosis, spinal cord injury, chronic inflammation of the prostate or urethra; relevant genital surgery; a female partner with vaginal complaints; any broken skin or wounds in the genital area.
- •Subjects on medication that is contraindicated, which may affect erection.
- •Subject and/or his female partner have any medication which may affect the safety of the subject, including but not limited to benzocaine drug interactions such as Sulphonamides and cholinesterase inhibitors.
- •Subject with premature ejaculation, erectile dysfunction, hypo or hyperthyroidism, hypogonadism, hyperprolactinemia, ejaculatory dysfunction, haemorrhagic disorder, hepatitis B or C, human immunodeficiency virus (HIV) infection or having had penile implant surgery.
- •Subjects and their female partners who have any relevant history of allergy including local anaesthetics, parabens, PABA, commercial hair dyes, paraphenylenediamine, lubricants and latex.
研究组 & 干预措施
Test condom A (NRL condom with 5% benzocaine paste)
Following randomisation each subject will be given one set of 8 condoms as per randomisation schedule. After reporting at least 4 duration records (from vaginal entry to ejaculation), subjects will return to the clinical site for collection of their next set of condoms.
干预措施: Test condom A (NRL condom with 5% benzocaine paste) (Device)
Test condom A (NRL condom with 5% benzocaine paste)
Following randomisation each subject will be given one set of 8 condoms as per randomisation schedule. After reporting at least 4 duration records (from vaginal entry to ejaculation), subjects will return to the clinical site for collection of their next set of condoms.
干预措施: Test condom B (NRL condom with 3% benzocaine paste) (Device)
Test condom A (NRL condom with 5% benzocaine paste)
Following randomisation each subject will be given one set of 8 condoms as per randomisation schedule. After reporting at least 4 duration records (from vaginal entry to ejaculation), subjects will return to the clinical site for collection of their next set of condoms.
干预措施: Control NRL condom (Device)
Test condom B (NRL condom with 3% benzocaine paste)
Following randomisation each subject will be given one set of 8 condoms as per randomisation schedule. After reporting at least 4 duration records (from vaginal entry to ejaculation), subjects will return to the clinical site for collection of their next set of condoms.
干预措施: Test condom A (NRL condom with 5% benzocaine paste) (Device)
Test condom B (NRL condom with 3% benzocaine paste)
Following randomisation each subject will be given one set of 8 condoms as per randomisation schedule. After reporting at least 4 duration records (from vaginal entry to ejaculation), subjects will return to the clinical site for collection of their next set of condoms.
干预措施: Test condom B (NRL condom with 3% benzocaine paste) (Device)
Test condom B (NRL condom with 3% benzocaine paste)
Following randomisation each subject will be given one set of 8 condoms as per randomisation schedule. After reporting at least 4 duration records (from vaginal entry to ejaculation), subjects will return to the clinical site for collection of their next set of condoms.
干预措施: Control NRL condom (Device)
Control NRL condom
Following randomisation each subject will be given one set of 8 condoms as per randomisation schedule. After reporting at least 4 duration records (from vaginal entry to ejaculation), subjects will return to the clinical site for collection of their next set of condoms.
干预措施: Test condom A (NRL condom with 5% benzocaine paste) (Device)
Control NRL condom
Following randomisation each subject will be given one set of 8 condoms as per randomisation schedule. After reporting at least 4 duration records (from vaginal entry to ejaculation), subjects will return to the clinical site for collection of their next set of condoms.
干预措施: Test condom B (NRL condom with 3% benzocaine paste) (Device)
Control NRL condom
Following randomisation each subject will be given one set of 8 condoms as per randomisation schedule. After reporting at least 4 duration records (from vaginal entry to ejaculation), subjects will return to the clinical site for collection of their next set of condoms.
干预措施: Control NRL condom (Device)
结局指标
主要结局
To determine the effectiveness of the Test Condom A compared with the Control NRL Condom at prolonging time to ejaculation.
时间窗: 4 weeks for each assessment period (intervention duration)
Subjects will be recording the duration (time in minutes:seconds) from vaginal entry to ejaculation for each condom use. The outcome is evaluated by the change from baseline with the Test Condom A compared to the Control NRL Condom, over a 4-week assessment period.
次要结局
- To determine the effectiveness of the Test Condom B compared with the Control NRL Condom at prolonging time to ejaculation.(4 weeks for each assessment period (intervention duration))
- To determine the effectiveness of the Test Condom A and Test Condom B compared with the Control NRL Condom at prolonging time to ejaculation for an increase of 2, 3, and 4 minutes.(4 weeks for each assessment period (intervention duration))
- To evaluate the sexual pleasure when using the Test Condom A or Test Condom B compared with the Control NRL Condom.(4 weeks for each assessment period (intervention duration))
- To evaluate the subject's improvement at "lasting longer" for both the Test Condom A and Test Condom B compared with the Control NRL Condom.(4 weeks for each assessment period (intervention duration))
- Subject's experience on the use of each type of condoms [Acceptability and In-Use Tolerability](19 weeks)