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Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy (ERECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00737893
Recruitment Status : Completed
First Posted : August 20, 2008
Results First Posted : August 13, 2020
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Prostate Cancer
Erectile Dysfunction
Interventions Drug: Placebo
Drug: Erythropoietin (EPO)
Enrollment 56
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Erythropoietin (EPO) Placebo
Hide Arm/Group Description

20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.

Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Placebo doses given the day before surgery, the day of surgery, and the day after surgery.

Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Period Title: Overall Study
Started 29 27
Completed 29 27
Not Completed 0 0
Arm/Group Title Erythropoietin (EPO) Placebo Total
Hide Arm/Group Description

20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.

Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Placebo doses given the day before surgery, the day of surgery, and the day after surgery.

Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Total of all reporting groups
Overall Number of Baseline Participants 29 27 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 29 participants 27 participants 56 participants
54
(51 to 60)
57
(52 to 61)
55.5
(51.5 to 60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 27 participants 56 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
29
 100.0%
27
 100.0%
56
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 27 participants 56 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   3.4%
0
   0.0%
1
   1.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   6.9%
5
  18.5%
7
  12.5%
White
26
  89.7%
22
  81.5%
48
  85.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants 27 participants 56 participants
29 27 56
1.Primary Outcome
Title Erectile Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain
Hide Description Survey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function.
Time Frame At 6 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythropoietin (EPO) Placebo
Hide Arm/Group Description:

20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.

Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Placebo doses given the day before surgery, the day of surgery, and the day after surgery.

Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Overall Number of Participants Analyzed 29 27
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
14
(6.5 to 24)
19
(8 to 23)
2.Secondary Outcome
Title Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain
Hide Description Survey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function.
Time Frame At 3 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythropoietin (EPO) Placebo
Hide Arm/Group Description:

20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.

Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Placebo doses given the day before surgery, the day of surgery, and the day after surgery.

Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Overall Number of Participants Analyzed 29 27
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
11
(6 to 22)
14
(6 to 23)
3.Secondary Outcome
Title Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain
Hide Description Survey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function.
Time Frame At 9 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythropoietin (EPO) Placebo
Hide Arm/Group Description:

20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.

Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Placebo doses given the day before surgery, the day of surgery, and the day after surgery.

Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Overall Number of Participants Analyzed 29 27
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
20
(8 to 27)
25
(12 to 28)
4.Secondary Outcome
Title Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain
Hide Description Survey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function.
Time Frame At 12 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythropoietin (EPO) Placebo
Hide Arm/Group Description:

20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.

Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Placebo doses given the day before surgery, the day of surgery, and the day after surgery.

Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Overall Number of Participants Analyzed 29 27
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
22
(15.5 to 26)
28
(18 to 30)
5.Secondary Outcome
Title Patient Score on the Overall IIEF Questionnaire
Hide Description Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function.
Time Frame At 3 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythropoietin (EPO) Placebo
Hide Arm/Group Description:

20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.

Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Placebo doses given the day before surgery, the day of surgery, and the day after surgery.

Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Overall Number of Participants Analyzed 29 27
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
33
(21 to 55)
40
(21 to 53)
6.Secondary Outcome
Title Patient Score on the Overall IIEF Questionnaire
Hide Description Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function.
Time Frame At 6 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythropoietin (EPO) Placebo
Hide Arm/Group Description:

20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.

Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Placebo doses given the day before surgery, the day of surgery, and the day after surgery.

Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Overall Number of Participants Analyzed 29 27
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
37.5
(28.5 to 52)
51
(32 to 55)
7.Secondary Outcome
Title Patient Score on the Overall IIEF Questionnaire
Hide Description Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function.
Time Frame At 9 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythropoietin (EPO) Placebo
Hide Arm/Group Description:

20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.

Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Placebo doses given the day before surgery, the day of surgery, and the day after surgery.

Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Overall Number of Participants Analyzed 29 27
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
50
(30 to 59)
55
(33 to 66)
8.Secondary Outcome
Title Patient Score on the Overall IIEF Questionnaire
Hide Description Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function.
Time Frame At 12 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythropoietin (EPO) Placebo
Hide Arm/Group Description:

20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.

Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Placebo doses given the day before surgery, the day of surgery, and the day after surgery.

Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Overall Number of Participants Analyzed 29 27
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
53
(39 to 62)
60.5
(44 to 68)
9.Secondary Outcome
Title Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
Hide Description Mental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health.
Time Frame At 3 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythropoietin (EPO) Placebo
Hide Arm/Group Description:

20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.

Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Placebo doses given the day before surgery, the day of surgery, and the day after surgery.

Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Overall Number of Participants Analyzed 29 27
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
54.9
(51.9 to 55.9)
55.9
(44.8 to 57.7)
10.Secondary Outcome
Title Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
Hide Description Mental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health.
Time Frame At 6 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythropoietin (EPO) Placebo
Hide Arm/Group Description:

20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.

Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Placebo doses given the day before surgery, the day of surgery, and the day after surgery.

Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Overall Number of Participants Analyzed 29 27
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
55.9
(49.4 to 58.3)
55.0
(50.6 to 57.8)
11.Secondary Outcome
Title Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
Hide Description Mental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health.
Time Frame At 9 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythropoietin (EPO) Placebo
Hide Arm/Group Description:

20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.

Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Placebo doses given the day before surgery, the day of surgery, and the day after surgery.

Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Overall Number of Participants Analyzed 29 27
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
55.9
(49.5 to 57.8)
53.8
(51.1 to 57.8)
12.Secondary Outcome
Title Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
Hide Description Mental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health.
Time Frame At 12 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythropoietin (EPO) Placebo
Hide Arm/Group Description:

20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.

Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Placebo doses given the day before surgery, the day of surgery, and the day after surgery.

Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Overall Number of Participants Analyzed 29 27
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
55.3
(51.8 to 57.5)
55.9
(51.4 to 57.9)
13.Secondary Outcome
Title Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
Hide Description Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100.
Time Frame At 3 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythropoietin (EPO) Placebo
Hide Arm/Group Description:

20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.

Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Placebo doses given the day before surgery, the day of surgery, and the day after surgery.

Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Overall Number of Participants Analyzed 29 27
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
43.6
(28.2 to 68.6)
49.4
(31.4 to 63.5)
14.Secondary Outcome
Title Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
Hide Description Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100.
Time Frame At 6 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythropoietin (EPO) Placebo
Hide Arm/Group Description:

20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.

Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Placebo doses given the day before surgery, the day of surgery, and the day after surgery.

Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Overall Number of Participants Analyzed 29 27
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
47.8
(35.9 to 65.1)
53.2
(37.8 to 72.5)
15.Secondary Outcome
Title Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
Hide Description Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100.
Time Frame At 9 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythropoietin (EPO) Placebo
Hide Arm/Group Description:

20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.

Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Placebo doses given the day before surgery, the day of surgery, and the day after surgery.

Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Overall Number of Participants Analyzed 29 27
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
59.6
(41.7 to 75)
70.5
(37.8 to 80.8)
16.Secondary Outcome
Title Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
Hide Description Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100.
Time Frame At 12 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythropoietin (EPO) Placebo
Hide Arm/Group Description:

20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.

Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Placebo doses given the day before surgery, the day of surgery, and the day after surgery.

Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Overall Number of Participants Analyzed 29 27
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
62.2
(46.5 to 77.9)
73.7
(48.1 to 86.5)
17.Secondary Outcome
Title Patient Score on the Quality of Erection Questionnaire (QEQ)
Hide Description Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality.
Time Frame At 3 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythropoietin (EPO) Placebo
Hide Arm/Group Description:

20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.

Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Placebo doses given the day before surgery, the day of surgery, and the day after surgery.

Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Overall Number of Participants Analyzed 29 27
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
20.8
(0 to 70.8)
37.5
(0 to 70.8)
18.Secondary Outcome
Title Patient Score on the Quality of Erection Questionnaire (QEQ)
Hide Description Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality.
Time Frame At 6 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythropoietin (EPO) Placebo
Hide Arm/Group Description:

20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.

Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Placebo doses given the day before surgery, the day of surgery, and the day after surgery.

Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Overall Number of Participants Analyzed 29 27
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
37.5
(0 to 70.8)
45.8
(0 to 75)
19.Secondary Outcome
Title Patient Score on the Quality of Erection Questionnaire (QEQ)
Hide Description Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality.
Time Frame At 9 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythropoietin (EPO) Placebo
Hide Arm/Group Description:

20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.

Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Placebo doses given the day before surgery, the day of surgery, and the day after surgery.

Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Overall Number of Participants Analyzed 29 27
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
66.7
(4.2 to 79.2)
70.8
(20.8 to 87.5)
20.Secondary Outcome
Title Patient Score on the Quality of Erection Questionnaire (QEQ)
Hide Description Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality.
Time Frame At 12 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythropoietin (EPO) Placebo
Hide Arm/Group Description:

20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.

Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Placebo doses given the day before surgery, the day of surgery, and the day after surgery.

Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Overall Number of Participants Analyzed 29 27
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
70.8
(22.9 to 85.4)
79.2
(41.7 to 100)
21.Secondary Outcome
Title Hemoglobin Level at 2 Weeks After Surgery
Hide Description Hemoglobin level at 2 weeks after surgery in grams per deciliter (g/dl).
Time Frame 2 weeks after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythropoietin (EPO) Placebo
Hide Arm/Group Description:

20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.

Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Placebo doses given the day before surgery, the day of surgery, and the day after surgery.

Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Overall Number of Participants Analyzed 29 27
Median (Inter-Quartile Range)
Unit of Measure: g/dl
14.7
(14.1 to 15.2)
13.6
(13.1 to 14.4)
22.Secondary Outcome
Title Number of Participants Requiring Transfusion During Hospitalization
Hide Description Assess the number of participants requiring transfusion during hospitalization.
Time Frame During hospital stay, up to 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythropoietin (EPO) Placebo
Hide Arm/Group Description:

20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.

Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Placebo doses given the day before surgery, the day of surgery, and the day after surgery.

Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Overall Number of Participants Analyzed 29 27
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame 1 year
Adverse Event Reporting Description Clavien-Dindo Complications (graded I, II, III, IV, and V) after surgery were assessed for all patients during hospitalization, at clinical follow-up visits, and via study survey follow-up. Clavien III or higher complications were considered serious.
 
Arm/Group Title Erythropoietin (EPO) Placebo
Hide Arm/Group Description

20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.

Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Placebo doses given the day before surgery, the day of surgery, and the day after surgery.

Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.

All-Cause Mortality
Erythropoietin (EPO) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)      0/27 (0.00%)    
Hide Serious Adverse Events
Erythropoietin (EPO) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/29 (3.45%)      1/27 (3.70%)    
Surgical and medical procedures     
Clavien III  [1]  1/29 (3.45%)  1 1/27 (3.70%)  1
Indicates events were collected by systematic assessment
[1]
Clavien III complication requiring procedure
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Erythropoietin (EPO) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/29 (0.00%)      3/27 (11.11%)    
Surgical and medical procedures     
Clavien I-II  [1]  0/29 (0.00%)  0 3/27 (11.11%)  3
Indicates events were collected by systematic assessment
[1]
Clavien I-II complication
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Hiten Patel
Organization: Johns Hopkins Brady Urological Institute
Phone: 410-502-7710
EMail: hiten.patel@lumc.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00737893    
Other Study ID Numbers: IRB00048594
ERECT, EPO ( Other Identifier: Johns Hopkins Brady Urological Institute )
First Submitted: August 19, 2008
First Posted: August 20, 2008
Results First Submitted: July 29, 2020
Results First Posted: August 13, 2020
Last Update Posted: August 13, 2020