A Study in Erectile Dysfunction

This study has been completed.

Sponsor:

Information provided by:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00833638

First received: January 30, 2009

Last updated: August 18, 2010

Last verified: August 2010

History of Changes

Results First Received: June 3, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Condition:	Erectile Dysfunction
Interventions:	Drug: Placebo Drug: Tadalafil

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The first phase of the study was a run-in phase that lasted for approximately 4 weeks. During this time, subjects did not use any form of treatment for erectile dysfunction and were instructed to make at least 4 sexual intercourse attempts with their sexual partner. The purpose of this phase was to obtain baseline data for analysis purposes.

Reporting Groups

	Description
Tadalafil 2.5 mg	No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
Tadalafil 5 mg	No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
Placebo	No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.

Participant Flow for 2 periods

Period 1: Phase 2: Double-blind Treatment Phase

	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
STARTED	121	118	133
COMPLETED	111	108	124
NOT COMPLETED	10	10	9
Adverse Event	1	2	0
Entry Criteria Not Met	3	2	1
Lost to Follow-up	1	2	1
Physician Decision	1	0	0
Protocol Violation	3	3	3
Sponsor Decision	0	0	2
Withdrawal by Subject	1	1	2

Period 2: Phase 3: Open-label Extension Phase

	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
STARTED	111	108	124
COMPLETED	110	105	122
NOT COMPLETED	1	3	2
Lost to Follow-up	1	2	0
Protocol Violation	0	1	2

Baseline Characteristics

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Reporting Groups

	Description
Tadalafil 2.5 mg	No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
Tadalafil 5 mg	No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
Placebo	No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
Total	Total of all reporting groups

Baseline Measures

	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo	Total
Number of Participants [units: participants]	121	118	133	372
Age [units: years] Mean ± Standard Deviation	59.63 ± 10.02	57.68 ± 11.07	59.23 ± 10.63	58.87 ± 10.58
Gender [units: participants]
Female	0	0	0	0
Male	121	118	133	372
Race/Ethnicity, Customized ^[1] [units: participants]
American Indian or Alaska Native	4	0	0	4
Asian	2	4	1	7
Black or African American	25	21	22	68
Multiple	1	6	2	9
Native Hawaiian or Other Pacific Islander	0	0	1	1
White	89	87	107	283
Region of Enrollment [units: participants]
United States	121	118	133	372
Sexual Encounter Profile Diary question number 1 ^[2] [units: percentage of participants] Mean ± Standard Deviation	74.04 ± 35.64	75.22 ± 35.69	82.26 ± 28.98	77.34 ± 33.55
Sexual Encounter Profile Diary question number 2 ^[3] [units: percentage of participants] Mean ± Standard Deviation	52.70 ± 40.58	54.20 ± 39.47	56.16 ± 37.14	54.41 ± 38.94
Sexual Encounter Profile Diary question number 3 ^[4] [units: percentage of participants] Mean ± Standard Deviation	30.90 ± 36.99	25.42 ± 32.62	29.95 ± 34.85	28.80 ± 34.85
Sexual Encounter Profile Diary question number 4 ^[5] [units: percentage of participants] Mean ± Standard Deviation	8.33 ± 19.18	4.96 ± 13.19	8.36 ± 16.88	7.26 ± 16.64
Sexual Encounter Profile Diary question number 5 ^[6] [units: percentage of participants] Mean ± Standard Deviation	7.67 ± 18.73	4.39 ± 12.31	8.08 ± 16.88	6.77 ± 16.27

[1]	American Indian or Alaska Native
[2]	Sexual Encounter Profile Diary question number 1: "Were you able to achieve at least some erection (some enlargement of the penis)?" Data are presented as the mean percentage of participants who answered yes.
[3]	Sexual Encounter Profile Diary question number 2: "Were you able insert your penis into your partner's vagina?" Data are presented as the mean percentage of participants who answered yes.
[4]	Sexual Encounter Profile Diary question number 3: "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of participants who answered yes.
[5]	Sexual Encounter Profile Diary question number 4: "Were you satisfied with the hardness of your erection?" Data are presented as the mean percentage of participants who answered yes.
[6]	Sexual Encounter Profile Diary question number 5: "Were you satisfied overall with this sexual experience?" Data are presented as the mean percentage of participants who answered yes.

Outcome Measures

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1. Primary:

Earliest Onset Day Measured by Cumulative Percentage of Participants With Yes Response to Sexual Encounter Profile Diary Question 3 [ Time Frame: 4 days during double-blind period ]

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2. Secondary:

Sexual Encounter Profile Diary Question Number 1, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses [ Time Frame: Baseline and 14 days double-blind period ]

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3. Secondary:

Sexual Encounter Profile Diary Question Number 2, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses [ Time Frame: Baseline and 14 days double-blind period ]

Show Outcome Measure 3

4. Secondary:

Sexual Encounter Profile Diary Question Number 3, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses [ Time Frame: Baseline and 14 days double-blind period ]

Show Outcome Measure 4

5. Secondary:

Sexual Encounter Profile Diary Question Number 4, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses [ Time Frame: Baseline and 14 days double-blind period ]

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6. Secondary:

Sexual Encounter Profile Diary Question Number 5, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses [ Time Frame: Baseline and 14 days double-blind period ]

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7. Secondary:

Sexual Encounter Profile Diary Question 3, the Overall Distribution of Time to Onset by Yes Responses [ Time Frame: 4 days double-blind period ]

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Measure Type	Secondary
Measure Title	Sexual Encounter Profile Diary Question 3, the Overall Distribution of Time to Onset by Yes Responses
Measure Description	Assessed was the median time to onset of efficacy (day when 50% of participants have had at least 1 successful intercourse attempt) within the first 4 days of therapy based on a "yes" response to the sexual encounter profile diary question 3: "Did your erection last long enough for you to have successful intercourse?" Data are based on participants who responded "yes". For the placebo group, onset of efficacy was not reached within the first 4 days of therapy, therefore, the analysis timeframe was expanded for this group to determine the median time to onset of efficacy.
Time Frame	4 days double-blind period
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Included in the analysis were all subjects with successful intercourse within the first 4 days of treatment, who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.

Reporting Groups

	Description
Tadalafil 2.5 mg	No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
Tadalafil 5 mg	No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
Placebo	No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.

Measured Values

	Tadalafil 2.5 mg	Tadalafil 5 mg	Placebo
Number of Participants Analyzed [units: participants]	61	69	58
Sexual Encounter Profile Diary Question 3, the Overall Distribution of Time to Onset by Yes Responses [units: days] Median ± Standard Error	4.0 ± 0.878	3.0 ± 0.384	6.0 ± 2.283

Statistical Analysis 1 for Sexual Encounter Profile Diary Question 3, the Overall Distribution of Time to Onset by Yes Responses

Groups ^[1]	Tadalafil 2.5 mg vs. Placebo
Method ^[2]	Log Rank
P Value ^[3]	0.301

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Tested was the null-hypothesis that no differences in the time to onset of efficacy exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No adjustment for multiplicity.

Statistical Analysis 2 for Sexual Encounter Profile Diary Question 3, the Overall Distribution of Time to Onset by Yes Responses

Groups ^[1]	Tadalafil 5 mg vs. Placebo
Method ^[2]	Log Rank
P Value ^[3]	0.046

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Tested was the null-hypothesis that no differences in the time to onset of efficacy exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No adjustment for multiplicity.

8. Secondary:

Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts [ Time Frame: 14 days during double-blind period ]

Show Outcome Measure 8

9. Secondary:

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 [ Time Frame: 14 days double-blind and 14 days open-label ]

Show Outcome Measure 9

10. Secondary:

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 [ Time Frame: 14-day double-blind and 14-day open-label ]

Show Outcome Measure 10

11. Secondary:

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 [ Time Frame: 14-day double-blind and 14-day open-label ]

Show Outcome Measure 11

12. Secondary:

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 [ Time Frame: 14 days double-blind and 14 days open-label ]

Show Outcome Measure 12

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00833638 History of Changes
Other Study ID Numbers:	12719, H6D-US-LVHZ
Study First Received:	January 30, 2009
Results First Received:	June 3, 2010
Last Updated:	August 18, 2010
Health Authority:	United States: Food and Drug Administration

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