Study the Safety and Effectiveness of Tadalafil in Men With Diabetes Who Have Problems Getting and Keeping an Erection

A Randomized, Double-Blind, Parallel-Design, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil (2.5 mg and 5 mg) Administered Once Daily to Men With Diabetes Mellitus and Erectile Dysfunction

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00547183

Enrollment

298

Registered

2007-10-22

Start date

2004-10-31

Completion date

2005-05-31

Last updated

2007-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impotence

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.

Interventions

DRUGtadalafil

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

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Change in the GAQ, SEP, IIEF, SEAR, and RSE scores.	12 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026