A Study to Evaluate Self-esteem and Relationships in Males With Erectile Dysfuntion
NCT00648596 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 780
Last updated 2021-02-01
Summary
To determine the improvement in the self-esteem domain score of the Self-Esteem/Overall Relationship (SEAR) questionnaire and the improvement in erectile function (obtained from the Erectile Function \[EF\] domain of the International Index of Erectile Function \[IIEF\]). Furthermore, to determine if the improvement obtained in self-esteem was related to the main erectile dysfunction (ED) co-morbidities type and/or number.
Conditions
Interventions
- DRUG
-
sildenafil
sildenafil 50 mg tablet by mouth 1 hour before sexual activity for 12 weeks; the dose could be increased to 100 mg or decreased to 25 mg.
- DRUG
-
placebo tablet by mouth 1 hour before sexual activity for 12 weeks
Sponsors & Collaborators
-
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-05-31
- Completion
- 2004-05-31
Countries
- Finland
- France
- Italy
- Poland
- Russia
- Spain
- Sweden
- United Kingdom
Study Locations
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