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A Study to Evaluate Self-esteem and Relationships in Males With Erectile Dysfuntion

Last updated on December 15, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Oulu, , 90100 Finland
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Erectile Dysfunction
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

-Men with a documented clinical diagnosis of ED confirmed by a Sexual Health Inventory-Male
(SHI-M) score of 21 or less and who have a sexual partner for the duration of the study
were included.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects who have previously taken, or it is suspected they have taken, more than 4
doses of sildenafil citrate, or any other phosphodiesterase type 5 (PDE-5) inhibitor,
or apomorphine, at any time prior to the screening visit or patients who have taken
any dose of these compounds in the last two months

- Subjects with resting sitting hypotension (BP
170/110mmHg)

- Subjects with significant cardiovascular disease, including cardiac failure,
myocardial infarction, unstable angina, stroke or transient ischaemic attack (TIA),
symptomatic or clinically significant cardiac arrhythmias in the last 3 months

- Patients on nitrates.

NCT00648596
Pfizer
Completed
A Study to Evaluate Self-esteem and Relationships in Males With Erectile Dysfuntion

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A Study to Evaluate Self-esteem and Relationships in Males With Erectile Dysfuntion
An International, Multicentre, Randomized, Parallel Group, Double Blind, Placebo Controlled, Flexible Dose Study to Evaluate Self-esteem and Relationships in Males With Erectile Dysfunction Treated With Sildenafil Citrate
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Erectile Dysfunction
  • 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
    placebo tablet by mouth 1 hour before sexual activity for 12 weeks
  • Placebo Comparator: Arm 2
    Intervention: Drug: placebo
  • Active Comparator: Arm 1
    Intervention: Drug: sildenafil
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
780
May 2004
Not Provided

Inclusion Criteria:

-Men with a documented clinical diagnosis of ED confirmed by a Sexual Health Inventory-Male (SHI-M) score of 21 or less and who have a sexual partner for the duration of the study were included.

Exclusion Criteria:

  • Subjects who have previously taken, or it is suspected they have taken, more than 4 doses of sildenafil citrate, or any other phosphodiesterase type 5 (PDE-5) inhibitor, or apomorphine, at any time prior to the screening visit or patients who have taken any dose of these compounds in the last two months
  • Subjects with resting sitting hypotension (BP < 90/50mmHg) or hypertension (BP > 170/110mmHg)
  • Subjects with significant cardiovascular disease, including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischaemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias in the last 3 months
  • Patients on nitrates.
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Finland,   France,   Italy,   Poland,   Russian Federation,   Spain,   Sweden,   United Kingdom
 
 
NCT00648596
A1481161
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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