NCT00833638已完成4 期
Tadalafil 2.5 mg and 5 mg Once a Day Compared to Placebo in Day of Onset of Efficacy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 372
- 试验地点
- 1
- 主要终点
- Earliest Onset Day Measured by Cumulative Percentage of Participants With Yes Response to Sexual Encounter Profile Diary Question 3
研究概览
简要总结
The purpose of this study is to determine the day of onset of efficacy of tadalafil dosed once-a-day.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male and at least 18 years old, with at least a 3-month history of erectile dysfunction (ED).
- •Anticipate having same adult female sexual partner during the study.
- •Agree to make at least 4 sexual intercourse attempts with the female partner during the 4-week run-in phase without medication.
- •Agree to make at least 1 sexual intercourse attempt per day with the female partner during days 1-4 following randomization (with a minimum of three attempts required during that period). Also agree to make at least 3 intercourse attempts during days 5-14 following randomization.
- •Agree not to use any other ED treatment during the study and for 24 hours after the final study visit.
- •Partner Inclusion Criteria:
- •Female and at least 18 years old.
- •Agree to make at least 4 sexual intercourse attempts with the male sexual study partner during the 4-week run-in phase without medication.
- •Agree to make at least 1 sexual intercourse attempt per day with the male partner during days 1-4 following randomization
- •Agree to make at least 3 intercourse attempts during days 5-14 following randomization.
排除标准
- •Previous or current treatment with tadalafil or any phosphodiesterase type 5 (PDE5) inhibitor on a daily basis for once daily use.
- •ED caused by other primary sexual disorders, or untreated or inadequately treated endocrine disease.
- •History of radical prostatectomy, other pelvic surgery or penile implant.
- •Clinically significant penile deformity in the opinion of the investigator.
- •Clinically significant renal insufficiency, or hepatobiliary disease as determined by the investigator.
- •Glycosylated hemoglobin of >11%.
- •Present with 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.
- •Have any significant cardiac conditions as described in the protocol exclusion criteria.
- •Have a history of significant central nervous system injuries within the last 6 months.
- •Have a history of Human Immunodeficiency Virus infection.
- •Have any condition that would interfere with the subject's ability to provide informed consent or comply with study instructions, would place subject at increased risk, or might confound the interpretation of the study results.
- •Currently receive treatment with nitrates, cancer chemotherapy, or antiandrogens (except finasteride taken as Propecia or Proscar, or Avodart [dutasteride]).
- •History of drug, alcohol, or substance abuse within the past 6 months, as assessed by the investigator.
- •Previously completed or withdrawn from any other study investigating tadalafil for once daily use.
- •Received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- •Prior ineffective treatment with any PDE5 inhibitor in the opinion of the investigator.
研究组 & 干预措施
Tadalafil 2.5 mg
Experimental
No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
干预措施: Tadalafil (Drug)
Tadalafil 5 mg
Experimental
No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
干预措施: Tadalafil (Drug)
Placebo
Placebo Comparator
No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
干预措施: Tadalafil (Drug)
结局指标
主要结局
Earliest Onset Day Measured by Cumulative Percentage of Participants With Yes Response to Sexual Encounter Profile Diary Question 3
时间窗: 4 days during double-blind period
Cumulative percentage of participants achieving successful intercourse, as measured by "yes" responses to Sexual Encounter Profile diary question 3 (SEP3). SEP3 asks if the participant's erection lasted long enough to have successful intercourse.
次要结局
- Sexual Encounter Profile Diary Question Number 1, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses(Baseline and 14 days double-blind period)
- Sexual Encounter Profile Diary Question Number 2, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses(Baseline and 14 days double-blind period)
- Sexual Encounter Profile Diary Question Number 3, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses(Baseline and 14 days double-blind period)
- Sexual Encounter Profile Diary Question Number 4, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses(Baseline and 14 days double-blind period)
- Sexual Encounter Profile Diary Question Number 5, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses(Baseline and 14 days double-blind period)
- Sexual Encounter Profile Diary Question 3, the Overall Distribution of Time to Onset by Yes Responses(4 days double-blind period)
- Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts(14 days during double-blind period)
- Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses During the Double-blind and Open-label Periods for Participants Who Were Assigned to Placebo in the Double-blind Treatment Period(14 days double-blind and 14 days open-label)
- Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses in the Double-blind Period and the Open-label Period for Participants Who Were Assigned to Tadalafil 2.5 mg in the Double-blind Treatment Period(14-day double-blind and 14-day open-label)
- Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses in the Double-blind Period and the Open-label Period for Participants Who Were Assigned to Tadalafil 5 mg in the Double-blind Treatment Period(14-day double-blind and 14-day open-label)
- Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses During the Double-blind Period and the Open-label Period for Participants Who Didn't Respond to Tadalafil 2.5 mg During Double-blind Period(14 days double-blind and 14 days open-label)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of LifeImpotenceNCT00422734Eli Lilly and Company342
Unknown
早期 1 期
Comparing The Effect of Tadalafil 5 mg/Day to Sildenafil 25 mg/Day on Neutrophil-Lymphocyte and Platelet-Lymphocyte Ratios in Erectile Dysfunction Patients; and Comparison of Clinical ResponseErectile Dysfunction and Neutrophil Lymphocyte RatioNCT05466695Assiut University74
进行中（未招募）
不适用
Tadalafil 5 mg Once a Day Compared to Placebo in Improving Erectile Dysfunction and Sexual Quality of Life - LVGHMedDRA version: 8.1Level: LLTClassification code 10061461Term: Erectile dysfunctionErectile DysfunctionEUCTR2006-002922-51-DEilly ICOS LLC320
进行中（未招募）
1 期
Tadalafil 5 mg Once a Day Compared to Placebo in Improving Erectile Dysfunction and Sexual Quality of Life - LVGHMedDRA version: 8.1Level: LLTClassification code 10061461Term: Erectile dysfunctionErectile DysfunctionEUCTR2006-002922-51-FRilly ICOS LLC320
进行中（未招募）
不适用
Tadalafil 5 mg Once a Day Compared to Placebo in Improving Erectile Dysfunction and Sexual Quality of Life - LVGHMedDRA version: 8.1Level: LLTClassification code 10061461Term: Erectile dysfunctionErectile DysfunctionEUCTR2006-002922-51-ATilly ICOS LLC320