Determine If the Stress That Comes With Not Developing an Erection Affects Tadalafil Effects

Does Presence of Distress Due to Erectile Dysfunction Affect the Effect of Tadalafil on Sexual Life and Life Satisfaction?

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00547599

Enrollment

659

Registered

2007-10-22

Start date

2003-04-30

Completion date

2004-01-31

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

To determine if patients who are distressed over having problems getting or maintaining an erection react differently to the medication than those who are not stressed over the issue.

Interventions

DRUGtadalafil

20 mg tadalafil tablet by mouth as needed, no more than once a day for 8 weeks.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 3 months history of erectile dysfunction (ED) * Anticipate a monogamous relationship with a female sexual partner * Be able to make minimum required sexual intercourse attempts * Abstain from using any other ED treatment

Exclusion criteria

* Nitrate use * Participated in previous tadalafil study or have a current tadalafil prescription * Heart attack within the last 90 days * Kidney problems * Certain heart problems

Design outcomes

Primary

Measure	Time frame
Change In Spontaneity Domain of PAIRS scale scores	8 weeks

Secondary

Measure	Time frame
Change in the Time Concerns, Sexual Self-Confidence & Sexual Miscommunication, domains of PAIRS scale scores	8 weeks

Countries

Sweden

Outcome results

None listed

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