NCT00547183

Brief Summary

Study to evaluate the safety and effectiveness of 2.5 mg and 5 mg tadalafil when taken by men with diabetes mellitus who have problems getting and maintaining an erection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
298

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2004

Shorter than P25 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, 2004

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 22, 2007

Completed
Last Updated

October 22, 2007

Status Verified

October 1, 2007

First QC Date

October 18, 2007

Last Update Submit

October 18, 2007

Conditions

Impotence

Outcome Measures

Primary Outcomes (1)

  • Effectiveness measured by IIEF score of questions 1-5 and 15 plus the percentages of positive responses to questions 2 and 3 in the SEP diary

    12 weeks

Secondary Outcomes (1)

  • Change in the GAQ, SEP, IIEF, SEAR, and RSE scores.

    12 weeks

Study Arms (3)

2

ACTIVE COMPARATOR

2.5 mg tadalafil

Drug: tadalafil

3

ACTIVE COMPARATOR

5 mg tadalafil

Drug: tadalafil

1

PLACEBO COMPARATOR
Drug: placebo

Interventions

tadalafilDRUG

2.5 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks

Also known as: LY450190, Cialis, IC351
2
placeboDRUG

Placebo tablet taken by mouth once a day, no more than 1 dose per day, for 12 weeks

1

Eligibility Criteria

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

You may qualify if:

  • History of erectile dysfunction for at least 3 months.
  • Currently have diabetes mellitus of at least 3 months duration.
  • Agree to not use any other ED treatment during the study.
  • Anticipate the same female sexual partner for the study.
  • Must be willing to make the required number of sexual attempts.

You may not qualify if:

  • History of other primary sexual disorder
  • Treatment with nitrates or potent CYP3A4 inhibitors
  • Have a penile implant or clinically significant penile deformity
  • History of certain heart problems
  • Have kidney or liver problems

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.

Genthin, Germany

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
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 18, 2007

First Posted

October 22, 2007

Study Start

October 1, 2004

Study Completion

May 1, 2005

Last Updated

October 22, 2007

Record last verified: 2007-10

Locations

DE(1)