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

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00648596
• Collaborator: (none)
• Enrollment: 780
• Locations: 67
• Arms: 2
• Duration (Months): 12
• Patients Per Site: 11.6
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: sildenafil; Drug: placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 780 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: May 1, 2003
• Actual Study Completion Date: May 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Arm 2	Drug: placebo; placebo tablet by mouth 1 hour before sexual activity for 12 weeks
Active Comparator: Arm 1	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.

Outcome Measures

Primary Outcome Measures

1. Change from baseline in the Self-esteem domain of the SEAR questionnaire [Week 12]

Secondary Outcome Measures

1. Correlation between the change in the SE domain of the SEAR questionnaire and the erectile function domain of the IIEF by number of ED co-morbidities [Week 12]

2. Differences in the global efficacy assessment question overall and by type of co-morbidity [Week 12]

3. Differences in the global satisfaction assessment questions overall and by type of co-morbidity [Week 12]

4. Comparisons between treatments in the SE domain of the SEAR questionnaire by type of co-morbidity (hypertension, hyperlipidemia, diabetes mellitus, benign prostatic hyperplasia, depression) [Week 12]

5. Changes in the sexual activity domain of the SEAR questionnaire overall and by type of co-morbidity [Week 12]

6. Changes in the relationship domain of the SEAR questionnaire overall and by type of co-morbidity [Week 12]

7. Changes of the SEAR questions overall and by type of co-morbidity [Week 12]

8. Changes of the IIEF questions overall and by type of co-morbidity [Week 12]

9. Changes of the IIEF domains overall and by type of co-morbidity [Week 12]

10. Degrees of severity in the IIEF erectile function [Week 12]

11. Correlation between the change in the SE domain of the SEAR questionnaire and the erectile function domain of the IIEF overall and by type of co-morbidity [Week 12]

12. Changes in the questions from the event log overall and by type of co-morbidity [Week 12]

13. Correlation between each success rate derived from the event log and the change in the SE domain of the SEAR questionnaire overall and by type of co-morbidity [Week 12]

14. Differences in the intercourse success rates derived from the event log overall and by type of comorbidity [Week 12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Oulu		Finland	90100
2	Pfizer Investigational Site	Tampere		Finland
3	Pfizer Investigational Site	Turku		Finland	20110
4	Pfizer Investigational Site	Clermont Ferrand		France	63023
5	Pfizer Investigational Site	LE Kremlin Bicentre		France	94275
6	Pfizer Investigational Site	Lyon Cedex 03		France	69437
7	Pfizer Investigational Site	MARSEILLE Cedex 20		France	13915
8	Pfizer Investigational Site	Neuilly-sur-seine		France	92200
9	Pfizer Investigational Site	NICE Cedex 01		France	06002
10	Pfizer Investigational Site	Nimes		France	30029
11	Pfizer Investigational Site	Toulouse		France	31403
12	Pfizer Investigational Site	Bari		Italy	70124
13	Pfizer Investigational Site	Catania		Italy	95124
14	Pfizer Investigational Site	Gallarate (VA)		Italy	21013
15	Pfizer Investigational Site	Modena		Italy	41100
16	Pfizer Investigational Site	Padova		Italy	35128
17	Pfizer Investigational Site	Roma		Italy	00100
18	Pfizer Investigational Site	Siena		Italy	53100
19	Pfizer Investigational Site	Torino		Italy	10126
20	Pfizer Investigational Site	Krakow		Poland
21	Pfizer Investigational Site	Lodz		Poland
22	Pfizer Investigational Site	Lublin		Poland
23	Pfizer Investigational Site	Olsztyn		Poland
24	Pfizer Investigational Site	Szczecin		Poland
25	Pfizer Investigational Site	Warszawa		Poland
26	Pfizer Investigational Site	Barnaul		Russian Federation	656099
27	Pfizer Investigational Site	Ekaterinburg		Russian Federation
28	Pfizer Investigational Site	Moscow		Russian Federation	105425
29	Pfizer Investigational Site	Moscow		Russian Federation	117036
30	Pfizer Investigational Site	Moscow		Russian Federation	121552
31	Pfizer Investigational Site	Moscow		Russian Federation	123448
32	Pfizer Investigational Site	Moscow		Russian Federation	125101
33	Pfizer Investigational Site	Moscow		Russian Federation	125206
34	Pfizer Investigational Site	Moscow		Russian Federation	127411
35	Pfizer Investigational Site	Moscow		Russian Federation
36	Pfizer Investigational Site	Nizhny Novgorod		Russian Federation
37	Pfizer Investigational Site	Novosibirsk		Russian Federation	630003
38	Pfizer Investigational Site	Novosibirsk		Russian Federation	630087
39	Pfizer Investigational Site	Rostov-on-don		Russian Federation	344068
40	Pfizer Investigational Site	Saint-Petersburg		Russian Federation	193318
41	Pfizer Investigational Site	Saint-Petersburg		Russian Federation
42	Pfizer Investigational Site	St. Petersburg		Russian Federation	197089
43	Pfizer Investigational Site	St. Petersburg		Russian Federation
44	Pfizer Investigational Site	San Juan	Alicante	Spain	03550
45	Pfizer Investigational Site	Barakaldo	Vizcaya	Spain	48903
46	Pfizer Investigational Site	Barcelona		Spain	08036
47	Pfizer Investigational Site	Madrid		Spain	28007
48	Pfizer Investigational Site	Madrid		Spain	28041
49	Pfizer Investigational Site	Madrid		Spain	28046
50	Pfizer Investigational Site	Valencia		Spain	46009
51	Pfizer Investigational Site	Valencia		Spain	46010
52	Pfizer Investigational Site	Zaragoza		Spain	50009
53	Pfizer Investigational Site	Karlshamn		Sweden	374 35
54	Pfizer Investigational Site	Malmo		Sweden	205 02
55	Pfizer Investigational Site	Skovde		Sweden	541 30
56	Pfizer Investigational Site	Stockholm		Sweden	171 76
57	Pfizer Investigational Site	Varnamo		Sweden	331 85
58	Pfizer Investigational Site	Vastervik		Sweden	593 81
59	Pfizer Investigational Site	Bodelwyddan	Denbighshire	United Kingdom	LL18 5UJ
60	Pfizer Investigational Site	South Yorkshire	Dn1 2et	United Kingdom
61	Pfizer Investigational Site	Belmont	Durham	United Kingdom	DH1 2QP
62	Pfizer Investigational Site	Blackpool	Lancashire	United Kingdom	FY4 3AD
63	Pfizer Investigational Site	Urmston	Manchester	United Kingdom	M41 0UH
64	Pfizer Investigational Site	Ashford	Middlesex	United Kingdom	TW15 3EA
65	Pfizer Investigational Site	Nr Lichfield	Staffordshire	United Kingdom	WS14 9JL
66	Pfizer Investigational Site	Addlestone	Surrey	United Kingdom	KT15 2BH
67	Pfizer Investigational Site	Taunton	Ta1 5da	United Kingdom

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00648596
• Other Study ID Numbers: A1481161
• First Posted: Apr 1, 2008
• Last Update Posted: Feb 1, 2021
• Last Verified: Jan 1, 2021

• Additional relevant MeSH terms: Erectile Dysfunction; Sildenafil Citrate

Study Results

No Results Posted as of Feb 1, 2021