NCT01026818|CompletedPhase 4ResultsDMC

A Study of Tadalafil After Radical Prostatectomy

REACTT

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

Eli Lilly and Company ClinicalTrials.gov

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2 other identifiers

13086H6D-EW-LVIK

Study Type

interventional

Target

583

Locations

10 countries

Sites

Timeline

RegisteredDec 2009

StartedNov 2009

CompletionOct 2012

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

583

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Nov 2009

Typical duration for phase_4

Geographic Reach

10 countries

52 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.9 years study duration

Study Start

First participant enrolled

November 1, 2009

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

December 3, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2009

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

November 14, 2013

Completed

Last Updated

January 14, 2014

Status Verified

December 1, 2013

Enrollment Period

2.9 years

First QC Date

December 3, 2009

Results QC Date

September 10, 2013

Last Update Submit

December 12, 2013

Conditions

Erectile Dysfunction

Keywords

Erectile DysfunctionRadical Prostatectomy

Outcome Measures

Primary Outcomes (1)

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.
Month 10.5

Secondary Outcomes (22)

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
+17 more secondary outcomes

Study Arms (3)

Tadalafil daily [5 milligrams (mg)]

EXPERIMENTAL

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.

Drug: Tadalafil

Tadalafil on demand (20 mg)

EXPERIMENTAL

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.

Drug: Tadalafil

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

TadalafilDRUG

Administered by mouth for 9 months

Also known as: Cialis, LY450190

Tadalafil daily [5 milligrams (mg)]Tadalafil on demand (20 mg)

PlaceboDRUG

Administered by mouth, daily or on demand for 9 months

Placebo

Eligibility Criteria

Age18 Years - 67 Years

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (52)

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.

Kortrijk, 8500, Belgium

Location

Leuven, 3000, Belgium

Location

Liège, 4000, Belgium

Location

Calgary, Alberta, T2W 1P9, Canada

Location

Victoria, British Columbia, V8T 5G1, Canada

Location

London, Ontario, N6A 4V2, Canada

Location

Créteil, 94010, France

Location

Grenoble, 38043, France

Location

Lyon, 69437, France

Location

Nice, 06002, France

Location

Nîmes, 30029, France

Location

Pierre-Bénite, 69495, France

Location

Berlin, 12203, Germany

Location

Braunschweig, 38126, Germany

Location

Dresden, 01307, Germany

Location

Essen, 45122, Germany

Location

Hamburg, 20246, Germany

Location

Hanover, 30625, Germany

Location

Herne, 44627, Germany

Location

Leipzig, 04103, Germany

Location

Leverkusen, 51375, Germany

Location

Acquavivadellefonti, 70021, Italy

Location

Bergamo, 24128, Italy

Location

Bologna, 40138, Italy

Location

Genova, 16132, Italy

Location

Milan, 20132, Italy

Location

Perugia, 06122, Italy

Location

's-Hertogenbosch, 5211 NL, Netherlands

Location

Amsterdam, 1066 CX, Netherlands

Location

Leiden, 2300 RC, Netherlands

Location

Nijmegen, 6532 SZ, Netherlands

Location

Rotterdam, 3045 PM, Netherlands

Location

Veldhoven, 5504 DB, Netherlands

Location

Bydgoszcz, 85-168, Poland

Location

Gdansk, 80-952, Poland

Location

Kielce, 25-734, Poland

Location

Warsaw, 02-005, Poland

Location

Zabrze, 41-800, Poland

Location

Aravaca, 28023, Spain

Location

Córdoba, 14004, Spain

Location

Madrid, 28046, Spain

Location

Majadahonda, 28222, Spain

Location

Málaga, 29010, Spain

Location

Seville, 41013, Spain

Location

Valencia, 46010, Spain

Location

Basel, CH-4031, Switzerland

Location

Lucerne, CH-6000, Switzerland

Location

Zurich, CH-8091, Switzerland

Location

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Middlesbrough, Cleveland, TS4 3BW, United Kingdom

Location

Stevenage, Herts, SG4 7NH, United Kingdom

Location

Withington, Manchester, M20 9BX, United Kingdom

Location

Related Publications (3)

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.
PMID: 26947602DERIVED
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.
PMID: 25879460DERIVED
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.
PMID: 24169081DERIVED

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 3, 2009

First Posted

December 4, 2009

Study Start

November 1, 2009

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

January 14, 2014

Results First Posted

November 14, 2013

Record last verified: 2013-12

Locations

ES(7)PL(5)IT(6)BE(3)FR(6)NL(6)CH(3)GB(4)CA(3)DE(9)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (22)

Study Arms (3)

Tadalafil daily [5 milligrams (mg)]

Tadalafil on demand (20 mg)

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (52)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations