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
Overview
- Phase
- Phase 4
- Intervention
- Tadalafil
- Conditions
- Erectile Dysfunction
- Sponsor
- Eli Lilly and Company
- Enrollment
- 583
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
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
Arms & Interventions
Tadalafil daily [5 milligrams (mg)]
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: Tadalafil
Tadalafil on demand (20 mg)
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: Tadalafil
Placebo
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: Placebo
Outcomes
Primary Outcomes
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
Time Frame: Month 10.5
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 Outcomes
- 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(Month 9 and Month 13.5)
- Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score(Randomization (Baseline), Months 9 and 10.5 and 13.5)
- 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)(Randomization (Baseline), Months 9 and 10.5 and 13.5)
- Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire Mean Score(Months 9 and 13.5)
- Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score(Randomization (Baseline), Months 9 and 13.5)
- Global Assessment Questions (GAQ) Question 1 at Month 9(Month 9)
- Global Assessment Question (GAQ) Question 1 at Month 13.5(Month 13.5)
- Global Assessment Question (GAQ) Question 2 at Month 9(Month 9)
- Global Assessment Question (GAQ) Question 2 at Month 13.5(Month 13.5)
- Residual Erectile Function (REF) at Baseline(Baseline)
- Residual Erectile Function (REF) at Month 2(Month 2)
- Residual Erectile Function (REF) at Month 5(Month 5)
- Residual Erectile Function (REF) at Month 9(Month 9)
- Residual Erectile Function (REF) at Month 10.5(Month 10.5)
- Residual Erectile Function (REF) at Month 13.5(Month 13.5)
- Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)(Randomization (Baseline), Months 9 and 10.5 and 13.5)
- Change From Baseline in 'Yes' Answers to Morning Erections(Randomization (Baseline), Month 10.5)
- Standardized Morning Erections Question (SMEQ) Score at Month 2(Month 2)
- Standardized Morning Erections Question (SMEQ) Score at Month 9(Month 9)
- Standardized Morning Erections Question (SMEQ) Score at Month 13.5(Month 13.5)
- Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score(Randomization (Baseline), Months 9 and 13.5)
- Change in Penile Length and Girth(Randomization (Baseline), Month 9)