A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of BP1.4979 in Adult Patients With Primary Premature Ejaculation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Bioprojet
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Intravaginal ejaculatory latence time (IELT)
研究概览
简要总结
The goal of this clinical trial is to learn if drug BP1.4979 works to treat primary premature ejaculation in adults. It will also learn about the safety of drug BP1.4979. The main questions it aims to answer are:
- Does drug BP1.4979 increase the time to ejaculation during sexual intercourse?
- Do participants have a good safety and tolerability of drug BP1.4979? Researchers will compare drug BP1.4979 to a placebo (a look-alike substance that contains no drug) to see if drug BP1.4979 works to treat primary premature ejaculation.
Participants will:
- Take drug primary premature ejaculation or a placebo per requested need prior to sexual intercourses for 12 weeks
- Visit the clinic 4 times for checkups and questionnaires completion and have 2 phone calls with the study team over a period of about 17 weeks
- Keep a diary of the intakes of the experimental drug, ejaculation time, ejaculation control, any unusual events concerning their health and any other medication taken
详细描述
Premature ejaculation is meant when ejaculation occurs too quickly during sexual activity with a partner, often within one minute of penetration, in 75-100% of sexual encounters and for no other reason. This can be a source of frustration and distress for both partners. There are two main types of PE: lifelong (primary) PE, present from the first sexual experience, and acquired (secondary) PE, which develops later in life and is often associated with other sexual problems (such as reduced libido or erectile dysfunction).
The exact cause of PE remains poorly understood. In the case of primary PE, it may be linked to brain chemicals (such as serotonin and dopamine), nervous system problems or psychological factors.
Current treatments include drugs and non-drug therapies. Medication works by increasing serotonin levels in the brain. They may be authorised, such as dapoxetine (a short-acting antidepressant) and anaesthetic creams (often used to reduce sensitivity, e.g. prilocaine-lidocaine), or prescribed off-label, such as other antidepressants or analgesics (e.g. tramadol). However, these treatments are often of limited efficacy, leaving patients without satisfactory solution.
The objective of this trial is to develop an effective treatment for primary PE specifically and to address an unmet medical need by improving the quality of life of the patients concerned.
The drug under study, called BP1.4979, acts on the dopamine pathway and is being tested to assess whether it can help men suffering from primary PE to better control their ejaculation. The study will compare BP1.4979 with a placebo (a tablet that looks identical but has no active ingredient), taken on demand before sexual intercourse, over a 12-week period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sponsor
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males aged 18 to 50 years old (both inclusive)
- •Diagnosis of primary (lifelong) PE according to the investigator
- •Intravaginal Ejaculatory Latency Time (IELT) estimated by the patient around one (1) minute at screening
- •Confirmation at randomization visit that at least 3 timed sexual intercourses with each IELT below 90 seconds occurred during the baseline period
- •Patient must be able to provide an informed consent and voluntarily express a willingness to participate in this study, and must sign and date an informed consent prior to any study specific procedure
- •Capability to participate in all study tests according to the investigator
排除标准
- •Diagnosis of acquired PE, pseudo-PE or natural variable PE
- •History of clinically significant abnormalities comprising cardiovascular (including especially prolonged QTc (>450 ms) and high degree (second and third) atrio-ventricular blocks)), hematological, neurological, and endocrine diseases
- •Current therapy with any treatment which may impact PE from 4 weeks prior to the screening visit
- •Current therapy with any treatment displaying dopamine D3 receptor agonist properties from 4 weeks prior to the screening visit
- •Concomitant intake of psychoactive / chem-sex substances
研究组 & 干预措施
Placebo
One tablet of matching placebo taken per requested need about 2 hours prior to sexual intercourse and at a 12-hour interval minimum over 12 weeks
干预措施: Placebo (Drug)
BP1.4979
One tablet of BP1.4979 taken per requested need about 2 hours prior to sexual intercourse and at a 12-hour interval minimum over 12 weeks
干预措施: BP1.4979 (Drug)
结局指标
主要结局
Intravaginal ejaculatory latence time (IELT)
时间窗: 12 weeks
IELT measured with a stopwatch started by the partner at vaginal intromission and stopped at the start of intravaginal ejaculation at each sexual encounter
次要结局
未报告次要终点