Trial · NCT01665599
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL | Day 90 | The data were presented using descriptive statistics. No statistical analysis was performed. |
| Secondary | The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL | Day 1 | The data were presented using descriptive statistics. No statistical analysis was performed. |
| Secondary | Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ) | Day 1; Day 90 | A validated high pressure liquid chromatography with tandem mass spectrometry detection (LC/MS/MS) method was used to determine the levels of total testosterone. |
| Secondary | Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax) | Day 1; Day 90 | A validated LC/MS/MS method was used to determine the levels of total testosterone. |
| Secondary | Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax) | Day 1; Day 90 | A validated LC/MS/MS method was used to determine the levels of total testosterone. |
| Secondary | Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave) | Day 1; Day 90 | A validated LC/MS/MS method was used to determine the levels of total testosterone. |
| Secondary | Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin) | Day 1; Day 90 | A validated LC/MS/MS method was used to determine the levels of total testosterone. |
| Secondary | Pharmacokinetics of Total Testosterone Measuring Time of Minimum Observed Concentration (Tmin) | Day 1; Day 90 | A validated LC/MS/MS method was used to determine the levels of total testosterone. |
| Secondary | Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ | Day 1; Day 90 | A validated LC/MS/MS method was used to determine the levels of DHT. |
| Secondary | Pharmacokinetics of DHT Measuring Tmax | Day 1; Day 90 | A validated LC/MS/MS method was used to determine the levels of DHT. |
| Secondary | Pharmacokinetics of DHT Measuring Cmax | Day 1; Day 90 | A validated LC/MS/MS method was used to determine the levels of DHT. |
| Secondary | Pharmacokinetics of DHT Measuring Cave | Day 1; Day 90 | A validated LC/MS/MS method was used to determine the levels of DHT. |
| Secondary | Pharmacokinetics of DHT Measuring Cmin | Day 1; Day 90 | A validated LC/MS/MS method was used to determine the levels of DHT. |
| Secondary | Pharmacokinetics of DHT Measuring Tmin | Day 1; Day 90 | A validated LC/MS/MS method was used to determine the levels of DHT. |
| Secondary | Change From Baseline in the International Index of Erectile Dysfunction (IIEF) Questionnaire | Day 91 | Data collected from the five domains of sexual functions were summarized by descriptive statistics. The domains are: 1. Erectile function (6 items, questions 1-5 and 15) (Score range: 1-30) 2. Orgasmic function (2 items, questions 9-10) (Score range: 0-10) 3. Sexual desire (2 items, questions 11-12) (Score range: 2-10) 4. Intercourse satisfaction (3 items, questions 6-8) (Score range: 0-15) 5. Overall satisfaction (2 items, questions 13-14) (Score range: 2-10) A score of 0-5 is awarded to questions 1 to 10 and a score of 1-5 is awarded to questions 11 to 15. Total score was calculated by summing up scores of each domain and ranged from 5 to 75. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function. |
| Secondary | Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Questionnaire | Day 91 | The MAF contains four sub-domains: 1. Severity (2 items, questions 1-2) (Score range: 2-20) 2. Distress (1 item, question 3) (Score range: 1-10) 3. Degree of interference in activities of daily living (11 items, questions 4-14) (Score range: 11-110) 4. Timing (2 items, questions 15-16) (Score range: 5-20) A score of 1-10 is awarded to each of the 14 questions across the 3 domains. The timing domain is categorical and was converted to 1-10 scale by multiplying each score by 2.5. Lower score in each domain indicates improvement in fatigue. To calculate GFI : Score of question 15 is converted to a 0-10 scale by multiplying each score by 2.5 and then sum questions 1, 2, 3, average of 4-14, and newly scored question 15. A score of zero is assigned to question 2-16, if patient select 'no fatigue' to question 1. Question 16 is not included in GFI calculation. Range of GFI: 1 (no fatigue) to 50 (severe fatigue). The data were presented using descriptive statistics. |
| Secondary | Change From Baseline in the SF-12 Health Questionnaire | Day 91 | Data collected from the SF-12 questionnaire was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contains four sub-domains: PCS: General Health (1 item), Physical Functioning (2 items), Role-Physical (2 items), Bodily Pain (1 item) MCS: Role-Emotional (2 items), Mental Health (2 items), Vitality (1 item), Social Functioning (1 item) The scale scores are calculated by summing responses across scale items and then transforming these raw scores to a 0-100 scale. Computerized scoring algorithms are used to produce norm-based scores for each scale (mean of 50 and standard deviation of 10) as well as the PCS and MCS summary scores. A zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The data were presented using descriptive statistics. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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