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NCT01122264

A Study in Patients With Erectile Dysfunction

NCT ID: NCT01122264

Last Updated: 2012-10-19

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

770 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-06-30

Brief Summary

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The purpose of this study is to investigate if treatment in erectile dysfunction with a long-acting drug (Tadalafil) taken once a day or taken as needed results in a longer treatment adherence and better long term outcomes (over 24 weeks), compared with a short-acting drug (Sildenafil Citrate) taken as needed.

Detailed Description

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Conditions

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Erectile Dysfunction

Keywords

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Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tadalafil on demand

10 milligrams (mg) or 20 mg on demand

Group Type EXPERIMENTAL

Tadalafil

Intervention Type DRUG

Administered orally for 24 weeks.

Tadalafil once a day

5 mg or 2.5 mg once a day

Group Type EXPERIMENTAL

Tadalafil

Intervention Type DRUG

Administered orally for 24 weeks.

Sildenafil Citrate

50 mg, 100 mg, or 25 mg on demand

Group Type ACTIVE_COMPARATOR

Sildenafil Citrate

Intervention Type DRUG

Administered orally for 24 weeks.

Interventions

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Tadalafil

Administered orally for 24 weeks.

Intervention Type DRUG

Sildenafil Citrate

Administered orally for 24 weeks.

Intervention Type DRUG

Other Intervention Names

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Cialis LY450190

Eligibility Criteria

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Inclusion Criteria

* History of Erectile Dysfunction (ED) of at least 3 months duration.
* Anticipate having the same adult female sexual partner during the study.
* Agree not to use any other treatment for ED and to participate in recording responses to questionnaires and other instruments used in this study.

Exclusion Criteria

* Previous or current treatment with tadalafil or any other phosphodiesterase type 5 (PDE5) inhibitor.
* ED caused by other primary sexual disorders, history of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection, or history of penile implant or clinically significant penile deformity.
* ED caused by untreated or inadequately treated endocrine disease.
* Current treatment with doxazosin, nitrates, cancer chemotherapy, or anti-androgens.
* Severe renal or hepatic impairment, history of malignant hypertension.
* Presence or history of specific heart conditions.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Carpentras, , France

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Chambéry, , France

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La Bouëxière, , France

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Lille, , France

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Lyon, , France

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Marseille, , France

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Montpellier, , France

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Mûrs-Erigné, , France

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Nantes, , France

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Rennes, , France

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Toulouse, , France

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Giengen an der Brenz, , Germany

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Grevenbroich, , Germany

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Holzminden, , Germany

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Koblenz, , Germany

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Leipzig, , Germany

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Leverkusen, , Germany

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Lübeck, , Germany

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Marburg, , Germany

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Mühlacker, , Germany

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Warburg, , Germany

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Heraklion, , Greece

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Larissa, , Greece

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Pátrai, , Greece

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Thessaloniki, , Greece

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Kutno, , Poland

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Legionowo, , Poland

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Lublin, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Porto, , Portugal

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Bucharest, , Romania

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Cluj-Napoca, , Romania

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Alcorcón, , Spain

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Aravaca, , Spain

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Barcelona, , Spain

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Coslada, , Spain

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Gijón, , Spain

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Madrid, , Spain

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Málaga, , Spain

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San Sebastián de los Reyes, , Spain

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Vigo, , Spain

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Fowey, Cornwall, United Kingdom

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Durham, County Durham, United Kingdom

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Plymouth, Devon, United Kingdom

Site Status

Countries

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France Germany Greece Poland Portugal Romania Spain United Kingdom

References

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Buvat J, Buttner H, Hatzimouratidis K, Vendeira PA, Moncada I, Boehmer M, Henneges C, Boess FG. Adherence to initial PDE-5 inhibitor treatment: randomized open-label study comparing tadalafil once a day, tadalafil on demand, and sildenafil on demand in patients with erectile dysfunction. J Sex Med. 2013 Jun;10(6):1592-602. doi: 10.1111/jsm.12130. Epub 2013 Apr 2.

Reference Type DERIVED

PMID: 23551622 (View on PubMed)

Other Identifiers

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H6D-EW-LVIJ

Identifier Type: OTHER

Identifier Source: secondary_id

13085

Identifier Type: -

Identifier Source: org_study_id