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A Study of Tadalafil After Radical Prostatectomy (REACTT)

Primary Purpose

Erectile Dysfunction

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Tadalafil

Placebo

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile Dysfunction, Radical Prostatectomy

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

scheduled to undergo Bilateral nerve-sparing radical prostatectomy (BNSRP) for organ-confined, non-metastatic prostate cancer
have a normal preoperative erectile function score of more or equal to 22 at screening(as evaluated by International Index of Erectile Function - Erectile Function domain (IIEF-EF))
develop Erectile Dysfunction (ED) (defined as the consistent inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse) after surgery
have an interest in resuming sexual activity as soon as possible after surgery and anticipate having the same adult female sexual partner during the study
agree not to use any other treatment for ED, including herbal and over-the-counter (OTC) medications, during the study
does not require the initiation of adjuvant therapy for prostate cancer

Exclusion Criteria:

history of ED
have received previous or current treatment with tadalafil or any other Phosphodiesterase Type 5 (PDE5) inhibitor
have undergone, or plan to undergo, radiation or hormonal therapy for prostate cancer
have a history of prostatic surgery or prostatic physical treatments
have a history of diabetes mellitus
have a history of galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption
have clinically significant renal insufficiency as determined by the investigator

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Tadalafil daily [5 milligrams (mg)]

Tadalafil on demand (20 mg)

Placebo

Arm Description

After the treatment period and 6-week study Drug-Free Period, all participants can continue on study in an optional 5-mg tadalafil 3-month Open-Label Period.

Outcomes

Primary Outcome Measures

Percentage of Participants With a Score of Greater Than or Equal to 22 in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire

Self-reported erectile function during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants with an IIEF-EF Total Score greater than or equal to (≥) 22.

Secondary Outcome Measures

Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain

Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score

Self-reported erectile function during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for baseline score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).

Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)

Self-reported overall satisfaction during past 4 weeks. Orgasmic function score is sum of Questions (Q)9 and 10 of IIEF. Scores range from 0 (no sexual stimulation or intercourse) to 5 (high orgasm) for each Q, total 0 to 10. Sexual desire score is sum of Q11 and 12 of IIEF. Scores range from 1 (low/no desire) to 5 (high desire) for each Q, total 2 to 10. Intercourse satisfaction score is sum of Q6, 7 and 8 of IIEF. Scores range from 0 (no attempts for Q6, did not attempt intercourse for Q7 and no intercourse for Q8) to 5 (high satisfaction) for each Q, total 0 to 15. Overall satisfaction score is sum of Q13 and 14 of IIEF. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each Q, total 2 to 10. Higher total scores for each domain indicate higher function. MMRM analysis was used to calculate LS mean and 95% CI. LS mean values are adjusted for baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).

Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire Mean Score

The EDITS questionnaire is a validated questionnaire consisting of 11 questions evaluating self-reported satisfaction with the erectile dysfunction (ED) treatment. Responses were based on the experiences during the previous 4 weeks. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS mean score was obtained by adding each individual result for all questions, dividing by the number of questions answered. The mean scores range from 0 (extremely low treatment satisfaction) to 4 (extremely high satisfaction). The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% Confidence Interval (CI). LS mean values are adjusted for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).

Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score

The SEAR questionnaire is a participant-reported measure of psychosocial outcomes in men with erectile dysfunction (ED). It consists of 14 items. Sexual Relationship domain consists of 8 items (items 1-8). Items 2-8 are rated on a scale of 1 (Never) to 5 (Always), whereas item 1 is reverse scored (1=Always and 5=Never). The total scores for sexual relationship domain range from 8-40 with higher scores indicating better relationship. Self-Esteem subdomain contains items 9 through 12 rated on a scale of 1 (no/low self-esteem) to 5 (high self-esteem). Total scores for Self-Esteem subscale range from 4-20 with higher scores indicating higher self-esteem. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% Confidence Interval (CI). LS mean values are adjusted for baseline domain score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).

Global Assessment Questions (GAQ) Question 1 at Month 9

GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).

Global Assessment Question (GAQ) Question 1 at Month 13.5

Global Assessment Question (GAQ) Question 2 at Month 9

GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).

Global Assessment Question (GAQ) Question 2 at Month 13.5

Residual Erectile Function (REF) at Baseline

The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)

Residual Erectile Function (REF) at Month 2

Residual Erectile Function (REF) at Month 5

Residual Erectile Function (REF) at Month 9

Residual Erectile Function (REF) at Month 10.5

Residual Erectile Function (REF) at Month 13.5

Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)

Participant-assessed diary has 5 questions: Question (Q)1: erection achievement, Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).

Change From Baseline in 'Yes' Answers to Morning Erections

The participants were asked to complete the morning erections diary every morning during the 4-week period before randomization and during the 6-week, Drug-Free, Washout Period. Data presented are the changes in the participant's percentage of "yes" responses relative to the number of days the question was answered during treatment. The analysis of covariance (ANCOVA) was used to calculate Least Square (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, baseline morning erections frequency, age group and country.

Standardized Morning Erections Question (SMEQ) Score at Month 2

Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ ("Do you ever wake up with an erection") using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never).

Standardized Morning Erections Question (SMEQ) Score at Month 9

Standardized Morning Erections Question (SMEQ) Score at Month 13.5

Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score

EPIC-26 (participants) contains 26 items and 5 domains: Urinary Incontinence (Items 1-4), Urinary Irritative/Obstructive (Items 5-8), Bowel (Items 10-15), Sexual (Items 16-21), and Hormonal (Items 22-26). Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0 to 100 scale for each domain, with higher scores representing better health-related quality of life. Responses are based on experiences during the previous 4 weeks. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for baseline domain score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).

Change in Penile Length and Girth

Measurements were performed with the penis in the flaccid state. The stretched penile length was measured from the tip of the glans to the pubopenile skin junction while applying tension to maximally stretch the penis. The penile circumference at midshaft was measured. All measurements were taken with a paper ruler to the nearest 0.5 centimeter (cm). The analysis of covariance (ANCOVA) was used to calculate Least Square (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, baseline, age group and country.

Full Information

NCT ID

NCT01026818

First Posted

December 3, 2009

Last Updated

December 12, 2013

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01026818

Brief Title

A Study of Tadalafil After Radical Prostatectomy

Acronym

REACTT

Official Title

A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Effect on Unassisted Erectile Function of the Early Use of Tadalafil 5 mg Once a Day and Tadalafil 20 mg On Demand Treatment for 9 Months in Subjects Undergoing Bilateral Nerve-Sparing Radical Prostatectomy

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study will include patients with localized prostate cancer who experience erectile dysfunction following bilateral nerve-sparing radical prostatectomy. Patients will be randomly assigned to three treatment arms: Tadalafil 5 mg once a day, Tadalafil 20 mg on demand (prior to anticipated sexual activity), and placebo. Patients will stay on therapy for 9 months and after withdrawal of medication for 6 weeks, patients will be evaluated for recovery of unassisted erectile function (without medication). An open-label extension for three months will evaluate the responsiveness of all patients to Tadalafil 5 mg once a day. Further objectives are to evaluate the treatment satisfaction of the respective therapies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction

Keywords

Erectile Dysfunction, Radical Prostatectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

583 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tadalafil daily [5 milligrams (mg)]

Arm Type

Experimental

Arm Description

After the treatment period and 6-week study Drug-Free Period, all participants can continue on study in an optional 5-mg tadalafil 3-month Open-Label Period.

Arm Title

Tadalafil on demand (20 mg)

Arm Type

Experimental

Arm Description

After the treatment period and 6-week study Drug-Free Period, all participants can continue on study in an optional 5-mg tadalafil 3-month Open-Label Period.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

After the treatment period and 6-week study Drug-Free Period, all participants can continue on study in an optional 5-mg tadalafil 3-month Open-Label Period.

Intervention Type

Drug

Intervention Name(s)

Tadalafil

Other Intervention Name(s)

Cialis, LY450190

Intervention Description

Administered by mouth for 9 months

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered by mouth, daily or on demand for 9 months

Primary Outcome Measure Information:

Title

Percentage of Participants With a Score of Greater Than or Equal to 22 in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire

Description

Time Frame

Month 10.5

Secondary Outcome Measure Information:

Title

Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain

Description

Time Frame

Month 9 and Month 13.5

Title

Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score

Description

Self-reported erectile function during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for baseline score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).

Time Frame

Randomization (Baseline), Months 9 and 10.5 and 13.5

Title

Description

Time Frame

Randomization (Baseline), Months 9 and 10.5 and 13.5

Title

Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire Mean Score

Description

Time Frame

Months 9 and 13.5

Title

Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score

Description

Time Frame

Randomization (Baseline), Months 9 and 13.5

Title

Global Assessment Questions (GAQ) Question 1 at Month 9

Description

Time Frame

Month 9

Title

Global Assessment Question (GAQ) Question 1 at Month 13.5

Description

Time Frame

Month 13.5

Title

Global Assessment Question (GAQ) Question 2 at Month 9

Description

Time Frame

Month 9

Title

Global Assessment Question (GAQ) Question 2 at Month 13.5

Description

Time Frame

Month 13.5

Title

Residual Erectile Function (REF) at Baseline

Description

Time Frame

Baseline

Title

Residual Erectile Function (REF) at Month 2

Description

Time Frame

Month 2

Title

Residual Erectile Function (REF) at Month 5

Description

Time Frame

Month 5

Title

Residual Erectile Function (REF) at Month 9

Description

Time Frame

Month 9

Title

Residual Erectile Function (REF) at Month 10.5

Description

Time Frame

Month 10.5

Title

Residual Erectile Function (REF) at Month 13.5

Description

Time Frame

Month 13.5

Title

Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)

Description

Time Frame

Randomization (Baseline), Months 9 and 10.5 and 13.5

Title

Change From Baseline in 'Yes' Answers to Morning Erections

Description

Time Frame

Randomization (Baseline), Month 10.5

Title

Standardized Morning Erections Question (SMEQ) Score at Month 2

Description

Time Frame

Month 2

Title

Standardized Morning Erections Question (SMEQ) Score at Month 9

Description

Time Frame

Month 9

Title

Standardized Morning Erections Question (SMEQ) Score at Month 13.5

Description

Time Frame

Month 13.5

Title

Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score

Description

Time Frame

Randomization (Baseline), Months 9 and 13.5

Title

Change in Penile Length and Girth

Description

Time Frame

Randomization (Baseline), Month 9

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

67 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: scheduled to undergo Bilateral nerve-sparing radical prostatectomy (BNSRP) for organ-confined, non-metastatic prostate cancer have a normal preoperative erectile function score of more or equal to 22 at screening(as evaluated by International Index of Erectile Function - Erectile Function domain (IIEF-EF)) develop Erectile Dysfunction (ED) (defined as the consistent inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse) after surgery have an interest in resuming sexual activity as soon as possible after surgery and anticipate having the same adult female sexual partner during the study agree not to use any other treatment for ED, including herbal and over-the-counter (OTC) medications, during the study does not require the initiation of adjuvant therapy for prostate cancer Exclusion Criteria: history of ED have received previous or current treatment with tadalafil or any other Phosphodiesterase Type 5 (PDE5) inhibitor have undergone, or plan to undergo, radiation or hormonal therapy for prostate cancer have a history of prostatic surgery or prostatic physical treatments have a history of diabetes mellitus have a history of galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption have clinically significant renal insufficiency as determined by the investigator

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

Facility Name

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2W 1P9

Country

Canada

Facility Name

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8T 5G1

Country

Canada

Facility Name

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4V2

Country

Canada

Facility Name

City

Creteil

ZIP/Postal Code

94010

Country

France

Facility Name

City

Grenoble

ZIP/Postal Code

38043

Country

France

Facility Name

City

Lyon

ZIP/Postal Code

69437

Country

France

Facility Name

City

Nice

ZIP/Postal Code

06002

Country

France

Facility Name

City

Nimes

ZIP/Postal Code

30029

Country

France

Facility Name

City

Pierre Benite

ZIP/Postal Code

69495

Country

France

Facility Name

City

Berlin

ZIP/Postal Code

12203

Country

Germany

Facility Name

City

Braunschweig

ZIP/Postal Code

38126

Country

Germany

Facility Name

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

City

Essen

ZIP/Postal Code

45122

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

City

Herne

ZIP/Postal Code

44627

Country

Germany

Facility Name

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

City

Leverkusen

ZIP/Postal Code

51375

Country

Germany

Facility Name

City

Acquavivadellefonti

ZIP/Postal Code

70021

Country

Italy

Facility Name

City

Bergamo

ZIP/Postal Code

24128

Country

Italy

Facility Name

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

City

Perugia

ZIP/Postal Code

06122

Country

Italy

Facility Name

City

Amsterdam

ZIP/Postal Code

1066 CX

Country

Netherlands

Facility Name

City

Leiden

ZIP/Postal Code

2300 RC

Country

Netherlands

Facility Name

City

Nijmegen

ZIP/Postal Code

6532 SZ

Country

Netherlands

Facility Name

City

Rotterdam

ZIP/Postal Code

3045 PM

Country

Netherlands

Facility Name

City

S-Hertogenbosch

ZIP/Postal Code

5211 NL

Country

Netherlands

Facility Name

City

Veldhoven

ZIP/Postal Code

5504 DB

Country

Netherlands

Facility Name

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

City

Kielce

ZIP/Postal Code

25-734

Country

Poland

Facility Name

City

Warsaw

ZIP/Postal Code

02-005

Country

Poland

Facility Name

City

Zabrze

ZIP/Postal Code

41-800

Country

Poland

Facility Name

City

Aravaca

ZIP/Postal Code

28023

Country

Spain

Facility Name

City

Cordoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

City

Majadahonda

ZIP/Postal Code

28222

Country

Spain

Facility Name

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

City

Basel

ZIP/Postal Code

CH-4031

Country

Switzerland

Facility Name

City

Luzern

ZIP/Postal Code

CH-6000

Country

Switzerland

Facility Name

City

Zurich

ZIP/Postal Code

CH-8091

Country

Switzerland

Facility Name

City

Cambridge

State/Province

Cambridgeshire

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

City

Middlesbrough

State/Province

Cleveland

ZIP/Postal Code

TS4 3BW

Country

United Kingdom

Facility Name

City

Stevenage

State/Province

Herts

ZIP/Postal Code

SG4 7NH

Country

United Kingdom

Facility Name

City

Withington

State/Province

Manchester

ZIP/Postal Code

M20 9BX

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

26947602

Citation

Montorsi F, Oelke M, Henneges C, Brock G, Salonia A, d'Anzeo G, Rossi A, Mulhall JP, Buttner H. Exploratory Decision-Tree Modeling of Data from the Randomized REACTT Trial of Tadalafil Versus Placebo to Predict Recovery of Erectile Function After Bilateral Nerve-Sparing Radical Prostatectomy. Eur Urol. 2016 Sep;70(3):529-37. doi: 10.1016/j.eururo.2016.02.036. Epub 2016 Mar 3.

Results Reference

derived

PubMed Identifier

25879460

Citation

Patel HR, Ilo D, Shah N, Cuzin B, Chadwick D, Andrianne R, Henneges C, Barry J, Hell-Momeni K, Branicka J, Buttner H. Effects of tadalafil treatment after bilateral nerve-sparing radical prostatectomy: quality of life, psychosocial outcomes, and treatment satisfaction results from a randomized, placebo-controlled phase IV study. BMC Urol. 2015 Apr 12;15:31. doi: 10.1186/s12894-015-0022-9.

Results Reference

derived

PubMed Identifier

24169081

Citation

Montorsi F, Brock G, Stolzenburg JU, Mulhall J, Moncada I, Patel HR, Chevallier D, Krajka K, Henneges C, Dickson R, Buttner H. Effects of tadalafil treatment on erectile function recovery following bilateral nerve-sparing radical prostatectomy: a randomised placebo-controlled study (REACTT). Eur Urol. 2014 Mar;65(3):587-96. doi: 10.1016/j.eururo.2013.09.051. Epub 2013 Oct 13.

Results Reference

derived

Learn more about this trial

A Study of Tadalafil After Radical Prostatectomy

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