A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy
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|ClinicalTrials.gov Identifier: NCT01816295|
Recruitment Status : Completed
First Posted : March 22, 2013
Results First Posted : October 2, 2015
Last Update Posted : December 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hypogonadism||Drug: Testosterone Solution Drug: Placebo Solution||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||715 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Parallel Study With an Open-Label Extension to Assess the Impact of Testosterone Solution on Total Testosterone, Sex Drive and Energy in Hypogonadal Men|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||April 2015|
Placebo Comparator: Placebo Solution
Placebo Solution applied topically once daily for 12 weeks.
Drug: Placebo Solution
Administered topically to axillae.
Experimental: Testosterone Solution
Testosterone Solution 60 milligram (mg) applied topically once daily with possible titration down to 30 milligram per day (mg/day) or up to 120 mg/day for 12 weeks and optional extension for 24 weeks.
Drug: Testosterone Solution
Administered topically to axillae.
- Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12 [ Time Frame: Week 12 ]Normal range for total serum testosterone was defined as 300 to 1050 nanograms per deciliter (ng/dL).
- Change From Baseline to Week 12 in Sexual Arousal, Interest, and Drive (SAID) Scale Scores [ Time Frame: 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.
- Change From Baseline to Week 12 in Hypogonadism Energy Diary (HED) Scores [ Time Frame: 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.
- Number of Participants With Prostate Specific Antigen (PSA) >4 Nanogram/Milliliter (ng/mL) [ Time Frame: Double Blind Baseline, Week 12, Open Label Baseline, Week 36 ]
- Change From Baseline in Total International Prostate Symptom Score (IPSS) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01816295
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|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|