Clinical trial NCT00833638: A Study in Erectile Dysfunction
Official title: Tadalafil 2.5 mg and 5 mg Once a Day Compared to Placebo in Day of Onset of Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2009-02-02
Enrollment: 372
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the day of onset of efficacy of tadalafil dosed once-a-day.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Earliest Onset Day Measured by Cumulative Percentage of Participants With Yes Response to Sexual Encounter Profile Diary Question 3
timeFrame: 4 days during double-blind period
Secondary outcomes:
measure: Sexual Encounter Profile Diary Question Number 1, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses
timeFrame: Baseline and 14 days double-blind period
measure: Sexual Encounter Profile Diary Question Number 2, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses
timeFrame: Baseline and 14 days double-blind period
measure: Sexual Encounter Profile Diary Question Number 3, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses
timeFrame: Baseline and 14 days double-blind period
measure: Sexual Encounter Profile Diary Question Number 4, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses
timeFrame: Baseline and 14 days double-blind period
measure: Sexual Encounter Profile Diary Question Number 5, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses
timeFrame: Baseline and 14 days double-blind period
measure: Sexual Encounter Profile Diary Question 3, the Overall Distribution of Time to Onset by Yes Responses
timeFrame: 4 days double-blind period
measure: Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts
timeFrame: 14 days during double-blind period
measure: 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
timeFrame: 14 days double-blind and 14 days open-label
measure: 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
timeFrame: 14-day double-blind and 14-day open-label
measure: 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
timeFrame: 14-day double-blind and 14-day open-label
measure: 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
timeFrame: 14 days double-blind and 14 days open-label
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Indiana
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: