Trial · NCT01816295
A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy
NCT01816295, Phase 3, Completed, Eli Lilly and Company; results first posted 2015-10-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy. Trials, record NCT01816295. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01816295
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy
- NCT number
- NCT01816295
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 715 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Hypogonadism
- Interventions
- Testosterone Solution, Placebo Solution
- First posted
- 2013-03-22
- Last updated
- 2015-12-28
- Other registries' IDs
- eudract:2012-004866-16
- Results first posted
- 2015-10-02
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12 | Week 12 | Normal range for total serum testosterone was defined as 300 to 1050 nanograms per deciliter (ng/dL). |
| Secondary | Change From Baseline to Week 12 in Sexual Arousal, Interest, and Drive (SAID) Scale Scores | Baseline, Week 12 | The SAID Scale is a self-administered instrument used to assess sexual arousal, interest, and sex drive in men with symptomatic hypogonadism. The SAID consists of 5 questions that were scored on a scale from 1 to 5, with "5" corresponding to greater levels of sexual arousal, interest, or drive. The SAID Scale total score was computed by summing the item scores and linearly transforming the sum to a 0 to 100 scale, with higher scores corresponding to greater sexual arousal, interest, and drive. Least squares (LS) mean change from baseline was calculated using an analysis of covariance (ANCOVA) with treatment group and the baseline value as covariates. |
| Secondary | Change From Baseline to Week 12 in Hypogonadism Energy Diary (HED) Scores | Baseline, Week 12 | The HED is a self-administered instrument used to assess real-time energy levels in men with symptomatic hypogonadism. It consists of 2 questions that were scored on a scale from 0 to 10, with "10" corresponding to "Full of Energy" or "Not Tired at All" (The Tiredness scale was reverse-mapped, as it was collected with "10" corresponding to "Extreme Tiredness"). The questionnaire was completed 3 times daily (forming 6 unique items) for 7 consecutive days. Item scores were computed by averaging the values for each item across 7 days. If more than 2 days were missing for an item, the item score was missing. The total score was computed by summing the item scores and linearly transforming the sum to a 0 to 100 scale, with higher scores corresponding to greater energy. If any item score was missing, the total score was missing. LS mean change from baseline was calculated using ANCOVA with treatment group and the baseline value as covariates. |
| Secondary | Number of Participants With Prostate Specific Antigen (PSA) >4 Nanogram/Milliliter (ng/mL) | Double Blind Baseline, Week 12, Open Label Baseline, Week 36 | |
| Other | Change From Baseline in Total International Prostate Symptom Score (IPSS) | Baseline, Week 12, Week 36 | The IPSS is a self-administered instrument used to assess for the severity of lower urinary tract symptoms. The IPSS consists of 7 questions that were scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. LS mean change from baseline was calculated using ANCOVA with treatment group and the baseline value as covariates. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12 | Week 12 | All randomized participants who completed 12 weeks of treatment and had non-missing testosterone concentration at week 12. | participants | NUMBER |
| SECONDARY | Change From Baseline to Week 12 in Sexual Arousal, Interest, and Drive (SAID) Scale Scores | Baseline, Week 12 | Randomized participants who reported low sex drive at baseline with non-missing SAID Scale data at baseline and at least one post baseline visit. Missing data endpoints were imputed using last observation carried forward (LOCF). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 12 in Hypogonadism Energy Diary (HED) Scores | Baseline, Week 12 | Randomized participants who reported low energy at baseline with non-missing HED questionnaire at baseline and at least one post baseline visit. Missing data endpoints were imputed using LOCF. | units on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Total International Prostate Symptom Score (IPSS) | Baseline, Week 12, Week 36 | All randomized participants with non-missing baseline IPSS measurement and at least one non-missing post baseline IPSS measurement. Missing data endpoints were imputed using LOCF. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Prostate Specific Antigen (PSA) >4 Nanogram/Milliliter (ng/mL) | Double Blind Baseline, Week 12, Open Label Baseline, Week 36 | All participants with non-missing PSA result at the specified time point. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12 | Placebo Solution | 43 | participants | ||
| Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12 | Testosterone Solution | 217 | participants | ||
| Change From Baseline to Week 12 in Sexual Arousal, Interest, and Drive (SAID) Scale Scores | Placebo Solution | 6.3 | Standard Error 0.99 | units on a scale | |
| Change From Baseline to Week 12 in Sexual Arousal, Interest, and Drive (SAID) Scale Scores | Testosterone Solution | 11.4 | Standard Error 1.02 | units on a scale | |
| Change From Baseline to Week 12 in Hypogonadism Energy Diary (HED) Scores | Placebo Solution | 7.5 | Standard Error 0.87 | units on a scale | |
| Change From Baseline to Week 12 in Hypogonadism Energy Diary (HED) Scores | Testosterone Solution | 10.5 | Standard Error 0.89 | units on a scale | |
| Change From Baseline in Total International Prostate Symptom Score (IPSS) | Placebo Solution | Change from Baseline to Week 12 | -0.7 | Standard Error 0.24 | units on a scale |
| Change From Baseline in Total International Prostate Symptom Score (IPSS) | Testosterone Solution | Change from Baseline to Week 12 | -0.9 | Standard Error 0.24 | units on a scale |
| Change From Baseline in Total International Prostate Symptom Score (IPSS) | Placebo Solution | Change from Baseline to Week 36 (n=247, 255) | -0.7 | Standard Error 0.28 | units on a scale |
| Change From Baseline in Total International Prostate Symptom Score (IPSS) | Testosterone Solution | Change from Baseline to Week 36 (n=247, 255) | -0.7 | Standard Error 0.27 | units on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double Blind Phase | STARTED | Placebo Solution | 357 | |
| Double Blind Phase | STARTED | Testosterone Solution | 358 | |
| Double Blind Phase | Received Study Drug | Placebo Solution | 356 | |
| Double Blind Phase | Received Study Drug | Testosterone Solution | 354 | |
| Double Blind Phase | COMPLETED | Placebo Solution | 294 | |
| Double Blind Phase | COMPLETED | Testosterone Solution | 302 | |
| Double Blind Phase | NOT COMPLETED | Placebo Solution | 63 | |
| Double Blind Phase | NOT COMPLETED | Testosterone Solution | 56 | |
| OLE Phase | STARTED | Placebo Solution | 275 | |
| OLE Phase | STARTED | Testosterone Solution | 283 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events1,254
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 |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo Solution - Double Blind | 1 | 356 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Testosterone Solution - Double Blind | 1 | 354 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Testosterone Solution - OLE | 0 | 558 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Placebo Solution - Double Blind | 0 | 356 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Testosterone Solution - Double Blind | 0 | 354 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Testosterone Solution - OLE | 1 | 558 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Placebo Solution - Double Blind | 0 | 356 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Testosterone Solution - Double Blind | 1 | 354 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Testosterone Solution - OLE | 1 | 558 | 1 |
| other | Polycythaemia | Blood and lymphatic system disorders | Placebo Solution - Double Blind | 0 | 356 | 0 |
1 to 10 of 1,254Source ClinicalTrials.gov
See all 1,254 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Solution - Double Blind | ||
| Total, all-cause mortality | Testosterone Solution - Double Blind | ||
| Total, all-cause mortality | Testosterone Solution - OLE | ||
| Total, other adverse events | Placebo Solution - Double Blind | 143 | 356 |
| Total, other adverse events | Testosterone Solution - Double Blind | 148 | 354 |
| Total, other adverse events | Testosterone Solution - OLE | 252 | 558 |
| Total, serious adverse events | Placebo Solution - Double Blind | 8 | 356 |
| Total, serious adverse events | Testosterone Solution - Double Blind | 4 | 354 |
| Total, serious adverse events | Testosterone Solution - OLE | 24 | 558 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Testosterone Solution vs Placebo Solution: Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12 |
Source Trial comparisons
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/NCT01816295
GET https://conductscience.org/api/trials/v1/NCT01816295/events?page=2