NCT00381732

Brief Summary

This is a multicenter, randomized, double blind, placebo-controlled, parallel design study to evaluate the efficacy and safety of 2.5mg and 5mg tadalafil taken once daily in men with erectile dysfunction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2003

Typical duration for phase_3

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 1, 2003

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2006

Completed
Last Updated

November 7, 2007

Status Verified

November 1, 2007

First QC Date

September 26, 2006

Last Update Submit

November 6, 2007

Conditions

Erectile Dysfunction

Keywords

Impotenceerectile dysfunction

Outcome Measures

Primary Outcomes (1)

  • Changes in erectile function measured at baseline and after 6 months of treatment with 2.5mg and 5mg tadalafil; assessment of safety after 1 and 2 years of therapy with 5mg tadalafil.

    24-128 weeks

Secondary Outcomes (1)

  • Changes in additional aspects of erectile function after 3 and 6 months of treatment; assessment of the pharmacokinetics of tadalafil 2.5mg and 5mg.

    24 weeks

Study Arms (3)

1

PLACEBO COMPARATOR

placebo tablet

Drug: placebo

2

ACTIVE COMPARATOR

2.5 mg tadalafil tablet

Drug: tadalafil

3

ACTIVE COMPARATOR

5 mg tadalafil tablet

Drug: tadalafil

Interventions

tadalafilDRUG

2.5 mg or 5 mg tadalafil tablet taken by mouth once a day for 24 weeks. Followed by an open label extension where all patients receive 5 mg doses.

Also known as: LY450190, Cialis, IC351
23
placeboDRUG

Placebo tablet taken by mouth once a day for 24 weeks. Placebo patient will receive 5 mg tadalafil tablet during the open label extension.

1

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men with erectile dysfunction
  • At least 18 years of age

You may not qualify if:

  • Certain chronic medical conditions including cardiac disease, congestive heart failure, kidney or liver disease, cancer and HIV
  • A history of certain impotence disorders
  • History of specified pelvic surgery
  • Any significant genital abnormality identified at the start of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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.

Bothell, Washington, United States

Location

Related Publications (2)

  • Porst H, Gacci M, Buttner H, Henneges C, Boess F. Tadalafil once daily in men with erectile dysfunction: an integrated analysis of data obtained from 1913 patients from six randomized, double-blind, placebo-controlled, clinical studies. Eur Urol. 2014 Feb;65(2):455-64. doi: 10.1016/j.eururo.2013.09.037. Epub 2013 Oct 2.

    PMID: 24119319DERIVED

  • Shabsigh R, Seftel AD, Kim ED, Ni X, Burns PR. Efficacy and safety of once-daily tadalafil in men with erectile dysfunction who reported no successful intercourse attempts at baseline. J Sex Med. 2013 Mar;10(3):844-56. doi: 10.1111/j.1743-6109.2012.02898.x. Epub 2012 Oct 4.

    PMID: 23035781DERIVED

Related Links

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

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 26, 2006

First Posted

September 28, 2006

Study Start

October 1, 2003

Study Completion

June 1, 2006

Last Updated

November 7, 2007

Record last verified: 2007-11

Locations

US(1)