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Effect of Testosterone in Men With Erectile Dysfunction (TED)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00512707
First Posted: August 8, 2007
Last Update Posted: June 29, 2017
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.
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Boston University
Results First Submitted: March 25, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Erectile Dysfunction
Testosterone Deficiency
Diabetes
Interventions: Drug: Sildenafil citrate (open label)
Drug: Testosterone gel
Other: Placebo gel

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Testosterone

Active Testosterone Gel

Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.

Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.

Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel.

Placebo

Placebo Gel

Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.

Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.


Participant Flow:   Overall Study
    Testosterone   Placebo
STARTED   70   70 
COMPLETED   60   58 
NOT COMPLETED   10   12 
Lost to Follow-up                5                11 
Developed skin irritation                2                1 
Developed a hematocrit exceeding 0.54                2                0 
Unable to tolerate the smell of the gel                1                0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline characteristic are provided prior to sildenafil administration (week -7)

Reporting Groups
  Description
Testosterone

Active Testosterone Gel

Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.

Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.

Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel.

Placebo

Placebo Gel

Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.

Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.

Total Total of all reporting groups

Baseline Measures
   Testosterone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 70   70   140 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 70   70   140 
   55.1  (8.3)   54.6  (8.5)   54.9  (8.4) 
Sex/Gender, Customized 
[Units: Participants]
Count of Participants
     
Male       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Male   70   70   140 
Race/Ethnicity, Customized [1] 
[Units: Participants]
Count of Participants
     
Race       
Participants Analyzed 
[Units: Participants]
 68   70   138 
Black      28  41.2%      33  47.1%      61  44.2% 
White      36  52.9%      32  45.7%      68  49.3% 
Other      4   5.9%      5   7.1%      9   6.5% 
[1] Based on the number of participants who responded.
BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 70   70   140 
   31.5  (6.4)   32.7  (6.0)   32.1  (6.2) 
Diabetes mellitus 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 70   70   140 
   13   14   27 
Hypertension 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 70   70   140 
   29   27   56 
Cardiovascular disease 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 70   70   140 
   35   32   67 
Total testosterone level 
[Units: ng/dL]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 70   70   140 
   248  (62)   254  (68)   251  (65) 
Total testosterone level <250 ng/dL 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 70   70   140 
   31   28   59 
Free testosterone level 
[Units: pg/mL]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 70   70   140 
   45  (15)   47  (16)   46  (15) 
International Index of Erectile Function (IIEF) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Erectile function       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Erectile function   12.2  (5.9)   12.0  (6.5)   12.1  (6.2) 
Orgasmic function       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Orgasmic function   5.1  (3.0)   5.4  (3.1)   5.3  (3.1) 
Sexual desire       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Sexual desire   5.6  (1.9)   5.6  (1.9)   5.6  (1.9) 
Intercourse satisfaction       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Intercourse satisfaction   6.1  (3.4)   6.0  (3.6)   6.0  (3.5) 
Overall satisfaction       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Overall satisfaction   4.3  (1.9)   4.5  (2.1)   4.4  (2.0) 
Composite IIEF       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Composite IIEF   33  (13)   33  (14)   33  (13) 
[1] IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function.
Sexual Encounter Profile (SEP) [1] 
[Units: Events/week]
Mean (Standard Deviation)
     
Sexual encounter attempts       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Sexual encounter attempts   2.5  (1.4)   2.3  (1.3)   2.4  (1.3) 
Vaginal penetrations       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Vaginal penetrations   1.5  (1.3)   1.4  (1.1)   1.4  (1.2) 
Ejaculations       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Ejaculations   0.92  (1.11)   1.14  (1.15)   1.02  (1.13) 
Overall satisfied with sexual encounters       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Overall satisfied with sexual encounters   0.49  (0.71)   1.07  (1.39)   0.76  (1.12) 
[1] Sexual Encounter Profile (SEP) diaries assesses frequency of sexual activity, sildenafil use, vaginal penetration, completion of intercourse with ejaculation, and overall satisfaction with sexual encounters. Minimum value is 0 with no maximum limit, wherein higher values representing better sexual encounter.
Successful sexual Intercourse in Sexual Encounter Profile (SEP) [1] 
[Units: Percentage of successful intercourse]
Mean (Standard Deviation)
     
Successful sexual Intercourse(Ejaculations)       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Successful sexual Intercourse(Ejaculations)   36  (40)   54  (45)   45  (43) 
Successful Sexual Intercourse (Satisfaction)       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Successful Sexual Intercourse (Satisfaction)   22  (34)   40  (45)   31  (40) 
[1] Sexual Encounter Profile (SEP) diaries assesses frequency of sexual activity, sildenafil use, vaginal penetration, completion of intercourse with ejaculation, and overall satisfaction with sexual encounters. Higher percentage of Ejaculations or Satisfaction in successful sexual intercourse represents better sexual function.
Male Sexual Health Questionnaire (MSHQ) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Erection       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Erection   6.7  (1.9)   6.9  (1.8)   6.8  (1.9) 
Ejaculation       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Ejaculation   22.2  (6.6)   22.2  (7.3)   22.2  (7.0) 
Sexual satisfaction       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Sexual satisfaction   19.5  (5.7)   18.7  (6.0)   19.1  (5.8) 
Sexual desire       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Sexual desire   8.6  (2.4)   8.6  (2.5)   8.6  (2.4) 
Sexual activity       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Sexual activity   5.5  (1.4)   5.6  (1.5)   5.5  (1.4) 
Composite MSHQ       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Composite MSHQ   41.7  (9.6)   40.8  (10.6)   41.2  (10.1) 
[1] MSHQ, a 25-item questionnaire, assesses sexual function and satisfaction. It consists 5 domains: Erection (3 items, ranging from 0 to 15 (best)), Ejaculation (7 items, ranging from 1 to 35 (best)), Satisfaction (6 items, ranging from 6 to 30 (best)), Sexual desire (4 items, ranging 4-20 (best)), and Sexual activity (3 items, ranging 3-15 (best)). A composite score is the sum of Ejaculation and Satisfaction domains, ranging from 7 to 65 (best), with higher score representing better sexual function and satisfaction.
Quality of Life Specific to Male Erection Difficulties (QOL-MED) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 70   70   140 
   47  (25)   51  (26)   49  (26) 
[1] The Quality of Life for men with Erection Difficulties (QOL-MED) is a cross-cultural instrument to measure quality of life specific to male erection difficulties. The 18 items for this scale were generated from interviews with men with erection difficulties by TH Wagner in 1996. Scores were standardized to 0 to 100. Higher QOL-MED scores reflect better quality of life.
Marital Interaction scale in CAncer Rehabilitation Evaluation System-Short Form (CARES-SF) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 70   70   140 
   0.91  (0.82)   0.79  (0.78)   0.85  (0.80) 
[1] CAncer Rehabilitation Evaluation System-short form (CARES-SF) marital interaction scale consists of 6 items (range from 0 (best) to 4) and mean of these 6 questions was used to determine intimacy and partner interaction. Lower CARES-SF scores correspond with improved marital interaction.
Psychological Global Well-Being Index (PGWBI) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Anxiety       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Anxiety   75  (15)   72  (18)   74  (17) 
Depressed mood       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Depressed mood   86  (14)   83  (15)   84  (14) 
Positive well-being       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Positive well-being   62  (17)   61  (19)   61  (18) 
Self-control       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Self-control   85  (13)   84  (14)   85  (14) 
General health       
Participants Analyzed 
[Units: Participants]
 70   70   140 
General health   73  (16)   73  (17)   73  (17) 
Vitality       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Vitality   65  (15)   65  (19)   65  (17) 
Global score       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Global score   73  (12)   72  (14)   73  (13) 
[1] PGWBI consists of 22 items each ranges from 0 (poor) to 5 (good) measuring Quality of Life (QoL). It measures 6 dimensions of perceived well-being and distress: Anxiety (5 questions), Depressed Mood (3 questions), Positive Well-Being (4 questions), Self Control (3 questions), General Health (3 questions), and Vitality (4 questions). An global score is the sum of 6 domains, ranging from 0 (poor QoL) to 110 (good QoL). The PGWBI global score and those of its 6 dimensions are normalized to 0-100. Higher score represents better QoL.
Derogatis Affects Balance Scale (DABS) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Joy       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Joy   13.0  (3.2)   12.9  (4.3)   13.0  (3.8) 
Contentment       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Contentment   13.1  (2.9)   12.8  (3.6)   12.9  (3.2) 
Vigor       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Vigor   12.2  (3.2)   12.3  (4.1)   12.2  (3.7) 
Affection       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Affection   14.4  (3.6)   14.2  (3.8)   14.3  (3.7) 
Depression       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Depression   3.9  (3.3)   4.7  (3.7)   4.3  (3.5) 
Anxiety       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Anxiety   5.4  (3.5)   6.2  (3.1)   5.8  (3.4) 
Guilt       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Guilt   4.1  (3.7)   4.4  (3.9)   4.3  (3.8) 
Hostiity       
Participants Analyzed 
[Units: Participants]
 70   70   140 
Hostiity   4.5  (3.5)   4.8  (3.7)   4.7  (3.6) 
[1] The DABS measures affectivity and affects balance via 4 positive (Joy, Contentment, Vigor, and Affection) and 4 negative (Anxiety, Depression, Guilt, and Hostility) dimensions that reflect basic emotional states. Each domain is scored separately from 0 to 20 with higher scores representing stronger emotional feeling.
Positive Affect Ratio (PAR) in Derogatis Affects Balance Scale (DABS) [1] 
[Units: Ratios]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 70   70   140 
   0.75  (0.14)   0.74  (0.16)   0.74  (0.15) 
[1] The DABS measures affectivity and affects balance via 4 positive (Joy, Contentment, Vigor, and Affection) and 4 negative (Anxiety, Depression, Guilt, and Hostility) dimensions that reflect basic emotional states. Positive Affects Ratio (PAR), ranging from 0 to 1, is the proportion of total scores (sum of all 8 domains) that is positive (sum of 4 positive domains). Higher PAR represents better affectivity.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Erectile Function Domain Score of the International Index of Erectile Function (IIEF)   [ Time Frame: Week 0, week 8, week 11, week 14 ]

2.  Secondary:   Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)   [ Time Frame: Week 0, week 8, week 11, week 14 ]

3.  Secondary:   Change From Baseline in Sexual Encounter Profile (SEP)   [ Time Frame: Week 0, week 8, week 14 ]

4.  Secondary:   Change From Baseline in Successful Sexual Intercourse of Sexual Encounter Profile (SEP)   [ Time Frame: Week 0, week 8, week 14 ]

5.  Secondary:   Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)   [ Time Frame: Week 0, Week 8, Week 14 ]

6.  Secondary:   Change From Baseline in Quality of Life Specific to Male Erection Difficulties (QOL-MED)   [ Time Frame: Week 0, Week 8, Week 14 ]

7.  Secondary:   Change From Baseline in Marital Interaction Scale of CAncer Rehabilitation Evaluation System-Short Form (CARES-SF)   [ Time Frame: Week 0, Week 8, Week 14 ]

8.  Secondary:   Change From Baseline in Psychological General Well-Being Index Score (PGWBI)   [ Time Frame: Week 0, Week 8, Week 14 ]

9.  Secondary:   Change From Baseline in Derogatis Affects Balance Scale (DABS)   [ Time Frame: Week 0, Week 8, Week 14 ]

10.  Secondary:   Change From Baseline in Positive Affects Ratio (PAR) of Derogatis Affects Balance Scale (DABS)   [ Time Frame: Week 0, Week 8, Week 14 ]

11.  Other Pre-specified:   Change From Baseline in Total Testosterone   [ Time Frame: Week 0, Week 14 ]

12.  Other Pre-specified:   Change From Baseline in Free Testosterone   [ Time Frame: Week 0, Week 14 ]

13.  Other Pre-specified:   Change From Baseline in Sex Hormone Binding Globulin (SHBG)   [ Time Frame: Week 0, Week 14 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Shalender Bhasin
Organization: Brigham and Women's Hospital
phone: 617-525-9150
e-mail: sbhasin@partners.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT00512707     History of Changes
Other Study ID Numbers: H-25065
R01HD047722-01A1 ( U.S. NIH Grant/Contract )
First Submitted: August 7, 2007
First Posted: August 8, 2007
Results First Submitted: March 25, 2017
Results First Posted: June 29, 2017
Last Update Posted: June 29, 2017