Trial · NCT01143818
ESPRIT Study in Hypogonadal Men
NCT01143818, Completed, Abbott; results first posted 2011-09-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ESPRIT Study in Hypogonadal Men. Trials, record NCT01143818. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01143818
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ESPRIT Study in Hypogonadal Men
- NCT number
- NCT01143818
- Status
- Completed
- Enrollment
- 1,053 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Hypogonadism
- Interventions
- AndroGel (testosterone gel) 1%
- First posted
- 2010-06-14
- Last updated
- 2011-10-17
- Results first posted
- 2011-09-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline to Month 6 in Aging Male Symptoms (AMS) in Mean Total Score | Baseline to Month 6 | The Aging Male Symptoms (AMS) test is self-administered and designed to assess symptoms of aging with a rating from none (0) to extremely severe (5) for 17 items from psychological (5 items), somatic (7 items), and sexual (5 items) categories. Total scores range from 17 (minimum) to 85 (maximum). The AMS total score was reported at baseline and at Month 6 and represented the sum of all the items. The percent change from baseline was calculated as the \[(AMS value at Month 6 - AMS value at baseline)/baseline value\] x 100. |
| Secondary | Percent Change From Baseline to Month 6 in the International Index of Erectile Function (IIEF) Total Score | Baseline to Month 6 | The International Index of Erectile Function (IIEF) test is a validated 15 question assessment designed to measure changes in erectile function (6 items), orgasmic function (2 items), sexual desire (2 items), intercourse satisfaction (3 items), and overall satisfaction (2 items). The scores ranged from 0 to 5 on each item with a lower score indicating greater dysfunction. A total IIEF score of 0 (minimum) to 75 (maximum) was possible and represented the sum of all the items at baseline and Month 6. The percent change = \[(IIEF value at Month 6-IIEF baseline value)/IIEF baseline value\]x 100. |
| Secondary | Percent Change From Baseline to Month 6 in the Multidimensional Fatigue Inventory (MFI) Total Score | Baseline to Month 6 | The MFI is a 20-item self-reported instrument designed to measure fatigue. Five scales measure different modes of fatigue: general fatigue (4 items), physical fatigue (4 items), mental fatigue (4 items), reduced motivation (4 items), and reduced activity items (4 items). The scores for each item range from 1 to 5. Each subscale includes 4 items with 5-point Likert scales and subscale scores range from 4 to 20 with a higher score indicating greater fatigue. The percent change=\[(MFI value at Month 6-MFI value at baseline)/MFI baseline value\] X 100. |
| Secondary | Percent Change From Baseline to Month 6 in Body Mass Index (BMI) | Baseline to Month 6 | The BMI was measured in kg/m\^2 and was reported at baseline and at the Month 6. BMI = weight (kg)/\[(height (m) x height (m)\] and was measured to 1 decimal point precision. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline to Month 6 in Aging Male Symptoms (AMS) in Mean Total Score | Baseline to Month 6 | The full analysis set included all participants in the safety analysis set who had an Aging Male Symptoms (AMS) score available at baseline and Month 6. | Percent Change | MEAN |
| SECONDARY | Percent Change From Baseline to Month 6 in the International Index of Erectile Function (IIEF) Total Score | Baseline to Month 6 | The full analysis set included all participants in the safety analysis set who had an IIEF score available at baseline and Month 6. | Percent Change | MEAN |
| SECONDARY | Percent Change From Baseline to Month 6 in the Multidimensional Fatigue Inventory (MFI) Total Score | Baseline to Month 6 | The full analysis set included all participants in the safety analysis set who had an MFI score available at baseline and Month 6. | Percent Change | MEAN |
| SECONDARY | Percent Change From Baseline to Month 6 in Body Mass Index (BMI) | Baseline to Month 6 | The full analysis set included all participants in the safety analysis set who had BMI available at baseline and Month 6. | Percent Change | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline to Month 6 in Aging Male Symptoms (AMS) in Mean Total Score | AndroGel (Testosterone Gel) 1% | -29.0 | Standard Deviation 22.6 | Percent Change | |
| Percent Change From Baseline to Month 6 in the International Index of Erectile Function (IIEF) Total Score | AndroGel (Testosterone Gel) 1% | 115.7 | Standard Deviation 226.3 | Percent Change | |
| Percent Change From Baseline to Month 6 in the Multidimensional Fatigue Inventory (MFI) Total Score | AndroGel (Testosterone Gel) 1% | -21.5 | Standard Deviation 33.5 | Percent Change | |
| Percent Change From Baseline to Month 6 in Body Mass Index (BMI) | AndroGel (Testosterone Gel) 1% | -2.38 | Standard Deviation 5.75 | Percent Change |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AndroGel (Testosterone Gel) 1% | 1,049 | |
| Overall Study | COMPLETED | AndroGel (Testosterone Gel) 1% | 799 | |
| Overall Study | NOT COMPLETED | AndroGel (Testosterone Gel) 1% | 250 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Angina pectoris | Cardiac disorders | AndroGel (Testosterone Gel) 1% | 1 | 1,049 | |
| serious | Atrial fibrillation | Cardiac disorders | AndroGel (Testosterone Gel) 1% | 1 | 1,049 | |
| serious | Hypertension | Vascular disorders | AndroGel (Testosterone Gel) 1% | 1 | 1,049 | |
| serious | Nausea | Gastrointestinal disorders | AndroGel (Testosterone Gel) 1% | 1 | 1,049 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AndroGel (Testosterone Gel) 1% | ||
| Total, other adverse events | AndroGel (Testosterone Gel) 1% | 0 | 1,049 |
| Total, serious adverse events | AndroGel (Testosterone Gel) 1% | 3 | 1,049 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01143818
GET https://conductscience.org/api/trials/v1/NCT01143818/registered