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A Study of Tadalafil After Radical Prostatectomy (REACTT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01026818
First received: December 3, 2009
Last updated: November 2, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Erectile Dysfunction
 Drug: Tadalafil
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Tadalafil
U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Percentage of subjects 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: Randomization to end of 6 weeks of study drug free washout ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects with a score of greater than or equal to 22 in the IIEF-EF Domain [ Time Frame: Randomization to end of 9 months of treatment, end of 3 months open-label treatment ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint in IIEF-EF total score [ Time Frame: Randomization to end of 9 months of treatment, end of 6 weeks of study drug free washout, end of 3 month open label treatment ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint in IIEF domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain) [ Time Frame: Randomization to end of 9 months of treatment, end of 6 weeks of study drug free washout, end of 3 month open label treatment ] [ Designated as safety issue: No ]
  • Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire summary score [ Time Frame: End of 9 months of treatment, end of 3 month open label treatment ] [ Designated as safety issue: No ]
  • Change from baseline in Self Esteem and Relationship (SEAR) questionnaire score [ Time Frame: Randomization, 2 months, 5 months, end of 9 months of treatment, end of 3 month open label treatment ] [ Designated as safety issue: No ]
  • Global Assessment Questions (GAQ) 1 and 2 [ Time Frame: End of 9 month treatment, end of 3 month open label treatment ] [ Designated as safety issue: No ]
  • Residual Erectile Function (REF) [ Time Frame: Randomization, 2 months, 5 months, end of 9 months treatment, end of 6 week study drug free washout, end of 3 month open label treatment ] [ Designated as safety issue: No ]
  • Change from baseline in 'yes' answers to questions 1 to 5 of the Sexual Encounter Profile (SEP) [ Time Frame: Randomization to end of 9 months of treatment, end of 6 weeks of study drug free washout, end of 3 month open label treatment ] [ Designated as safety issue: No ]
  • Change from baseline in 'yes' answers to morning erections [ Time Frame: Randomization to end of 6 week study drug free washout ] [ Designated as safety issue: No ]
  • Standardised Morning Erections Question score [ Time Frame: 2 months, 5 months, end of 9 months treatment, end of 3 month open label treatment ] [ Designated as safety issue: No ]
  • Change from baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire score [ Time Frame: Randomization to end of 9 months of treatment, end of 3 month open label treatment ] [ Designated as safety issue: No ]
  • Change in penile length and girth (cm) [ Time Frame: Randomization to end of 9 months treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 412
Study Start Date: November 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tadalafil daily (5mg)
After the treatment period and 6 week study drug free period, all participants can continue on study in an optional 5mg tadalafil 3 month open label period.
 Drug: Tadalafil
Administered by mouth for 9 months
Other Names:
  • Cialis
  • LY450190
Experimental: Tadalafil on demand (20mg)
After the treatment period and 6 week study drug free period, all participants can continue on study in an optional 5mg tadalafil 3 month open label period.
 Drug: Tadalafil
Administered by mouth for 9 months
Other Names:
  • Cialis
  • LY450190
Placebo Comparator: Placebo
After the treatment period and 6 week study drug free period, all participants can continue on study in an optional 5mg tadalafil 3 month open label period.
 Drug: Placebo
Administered by mouth, daily or on demand for 9 months
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 67 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 PDE5 (Phosphodiesterase Type 5) 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01026818

  Show 52 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01026818     History of Changes
Other Study ID Numbers: 13086, H6D-EW-LVIK
Study First Received: December 3, 2009
Last Updated: November 2, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Eli Lilly and Company:
Erectile Dysfunction
Radical Prostatectomy

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Tadalafil
Phosphodiesterase 5 Inhibitors
 Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013