Hypogonadism
Conditions
Brief summary
This study will evaluate if testosterone solution can raise testosterone hormone levels into the normal range after treatment for up to 9 Weeks, in those participants with a documented history of subtherapeutic levels \[total testosterone \<300 nanograms per deciliter (ng/dL)\] when previously treated with a topical testosterone gel.
Interventions
DRUGTopical Testosterone Solution
Administered topically to axillae.
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to read, understand, and provide signed informed consent before starting trial activities related to this study (including discontinuing testosterone replacement therapy prior to Screening) * Male participants with a diagnosis of hypogonadism and documented biochemical failure (total testosterone \<300 ng/dL) when treated with the highest dose of a topical testosterone gel tolerated by the participant. Documentation of biochemical failure includes: the name and dose of the topical testosterone gel, a lab report showing a total testosterone level \<300 ng/dL while on therapy, or a written chart report stating that there was a clear lack of efficacy, including the participant's serum total testosterone level at the time of failure * Screening serum total testosterone level of \<300 ng/dL (based on the average of 2 morning blood samples taken at least 30 minutes apart) at Screening * Prostate Specific Antigen (PSA) \<4 nanogram per milliliter (ng/mL) at Screening * If the participant is receiving testosterone replacement therapy and is willing to discontinue testosterone replacement therapy to enter the study, their screening total testosterone level cannot be checked until at least 14 days after discontinuing topical therapies, or after at least 28 days for participants using short-acting intramuscular (IM) therapies
Exclusion criteria
* Any previous treatment with testosterone topical solution (LY900011) * Known or suspected carcinoma (or history of carcinoma) of the prostate or suspicious nodules on digital rectal exam at Screening * Known or suspected breast cancer or history of breast cancer * Severe sleep apnea (untreated or unsuccessfully treated) in the opinion of the study investigator * Use of long-acting IM testosterone undecanoate in the 6-month period prior to Screening * History of the use of an implanted testosterone pellets (Testopel) * International Prostate Symptom Score (IPSS) total score \>19 at Screening * Hematocrit ≥50% at Screening. For sites located at elevations ≥4500 feet, participants will be excluded with hematocrit \>54% according to investigator discretion. Any participant with a hematocrit \>54% at later study visits will be withdrawn from the study * Significant history of allergy and/or sensitivity to the drug products or excipients, including any history of sensitivity to testosterone and/or sunscreens * Dermatologic condition in underarm area that might interfere with testosterone absorption (for example, eczema) or that could be exacerbated by topical testosterone replacement therapy * History of luteinizing hormone-releasing hormone (LHRH) antagonist or agonist treatment in the 6 months prior to Screening * Exhibit any evidence of congestive heart failure \[New York Heart Association (NYHA) Class 2 or above\] within 6 months prior to Screening * Exhibit evidence of severe renal impairment \[creatinine clearance \<30 milliliter per minute (mL/min) as determined by the Cockcroft-Gault formula\] at Screening * Exhibit a history of severe liver disease or clinical evidence of hepatic impairment at Screening * Any condition that would interfere with the participant's ability to provide informed consent, or comply with study instructions, or would place the participant at increased risk, or might confound the interpretation of the study results * Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted * Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device (other than the investigational product used in this study), or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Normal Serum Testosterone Levels | Baseline through Study Completion (Up to 9 Weeks) | Normal serum testosterone level is defined as ≥300 to ≤1050 nanograms/deciliter (ng/dL). Serum testosterone levels were measured by liquid chromatography and tandem mass spectrometry (LC/MS-MS). Percentage of participants = (number of participants who achieved normal serum testosterone level) / (number of treated participants who had serum testosterone level measured) \* 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Serum Testosterone Levels | Baseline, Study Completion (Up to 9 Weeks) | Serum testosterone levels were measured by LC/MS-MS. |
| Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Study Days 15, 22, 36, 43, 57, 64 and endpoint | PGI-I for sexual drive is a participant-rated questionnaire that measure change in sexual drive after a participant begins the study drug. The questionnaire was completed at every visit post baseline using a 7-point scale where a score of 1 indicated that the participant's sexual drive was very much better, a score of 4 indicated that the participant had experienced no change in sexual drive and a score of 7 indicated that the participant's sexual drive was very much worse. Percentage of participants = (number of participants in the category) / (total number of participants who responded to the questionnaire) \* 100. |
| Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Study Days 15, 22, 36, 43, 57, 64 and endpoint | PGI-I for energy level is a participant-rated questionnaire that measures change in energy level after a participant begins the study drug. The questionnaire was completed at every visit post baseline using a 7-point scale where a score of 1 indicated that the participant's energy level was very much better, a score of 4 indicated that the participant had experienced no change in energy level and a score of 7 indicated that the participant's energy level was very much worse. Percentage of participants = (number of participants in the category) / (total number of participants who responded to the questionnaires) \* 100. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Topical Testosterone Solution Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks. | 78 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Topical Testosterone Solution |
|---|---|
| Age, Continuous | 57.3 years STANDARD_DEVIATION 10.93 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 70 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 73 Participants |
| Region of Enrollment United States | 78 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 22 / 78 |
| serious Total, serious adverse events | 0 / 78 |
Outcome results
Primary
Percentage of Participants Achieving Normal Serum Testosterone Levels
Normal serum testosterone level is defined as ≥300 to ≤1050 nanograms/deciliter (ng/dL). Serum testosterone levels were measured by liquid chromatography and tandem mass spectrometry (LC/MS-MS). Percentage of participants = (number of participants who achieved normal serum testosterone level) / (number of treated participants who had serum testosterone level measured) \* 100.
Time frame: Baseline through Study Completion (Up to 9 Weeks)
Population: All enrolled participants who received at least 1 dose of study drug and had serum testosterone level measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Topical Testosterone Solution | Percentage of Participants Achieving Normal Serum Testosterone Levels | 94.7 percentage of participants |
Secondary
Change From Baseline in Serum Testosterone Levels
Serum testosterone levels were measured by LC/MS-MS.
Time frame: Baseline, Study Completion (Up to 9 Weeks)
Population: All enrolled participants who received at least 1 dose of study drug with non-missing data at baseline and at least 1 post baseline measurement. Last-observation-carried-forward (LOCF) was used to impute missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical Testosterone Solution | Change From Baseline in Serum Testosterone Levels | 354.8 ng/dL | Standard Deviation 280.99 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
PGI-I for energy level is a participant-rated questionnaire that measures change in energy level after a participant begins the study drug. The questionnaire was completed at every visit post baseline using a 7-point scale where a score of 1 indicated that the participant's energy level was very much better, a score of 4 indicated that the participant had experienced no change in energy level and a score of 7 indicated that the participant's energy level was very much worse. Percentage of participants = (number of participants in the category) / (total number of participants who responded to the questionnaires) \* 100.
Time frame: Study Days 15, 22, 36, 43, 57, 64 and endpoint
Population: All enrolled participants who received at least 1 dose of study drug and responded to PGI-I energy level questionnaire at specified time points. Endpoint is defined as the last non-missing PGI-I scale for energy level collected from Day 15 through end of study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Very much better - Day 57 (n=6) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Very much better - Day 15 (n=75) | 4.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Much better - Day 15 (n=75) | 16.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | A little better - Day 15 (n=75) | 44.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | No change - Day 15 (n=75) | 36.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | A little worse - Day 15 (n=75) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Much worse - Day 15 (n=75) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Very much worse - Day 15 (n=75) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Very much better - Day 22 (n=76) | 7.89 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Much better - Day 22 (n=76) | 27.63 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | A little better - Day 22 (n=76) | 40.79 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | No change - Day 22 (n=76) | 22.37 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | A little worse - Day 22 (n=76) | 1.32 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Much worse - Day 22 (n=76) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Very much worse - Day 22 (n=76) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Very much better - Day 36 (n=22) | 4.55 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Much better - Day 36 (n=22) | 18.18 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | A little better - Day 36 (n=22) | 50.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | No change - Day 36 (n=22) | 22.73 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | A little worse - Day 36 (n=22) | 4.55 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Much worse - Day 36 (n=22) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Very much worse - Day 36 (n=22) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Very much better - Day 43 (n=22) | 4.55 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Much better - Day 43 (n=22) | 27.27 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | A little better - Day 43 (n=22) | 40.91 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | No change - Day 43 (n=22) | 22.73 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | A little worse - Day 43 (n=22) | 4.55 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Much worse - Day 43 (n=22) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Very much worse - Day 43 (n=22) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Much better - Day 57 (n=6) | 33.33 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | A little better - Day 57 (n=6) | 50.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | No change - Day 57 (n=6) | 16.67 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | A little worse - Day 57 (n=6) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Much worse - Day 57 (n=6) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Very much worse - Day 57 (n=6) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Very much better - Day 64 (n=6) | 16.67 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Much better - Day 64 (n=6) | 16.67 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | A little better - Day 64 (n=6) | 33.33 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | No change - Day 64 (n=6) | 33.33 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | A little worse - Day 64 (n=6) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Much worse - Day 64 (n=6) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Very much worse - Day 64 (n=6) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Very much better - Endpoint (n=77) | 10.39 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Much better - Endpoint (n=77) | 29.87 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | A little better - Endpoint (n=77) | 35.06 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | No change - Endpoint (n=77) | 22.08 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | A little worse - Endpoint (n=77) | 2.60 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Much worse - Endpoint (n=77) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level | Very much worse - Endpoint (n=77) | 0.00 percentage of participants |
Secondary
Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
PGI-I for sexual drive is a participant-rated questionnaire that measure change in sexual drive after a participant begins the study drug. The questionnaire was completed at every visit post baseline using a 7-point scale where a score of 1 indicated that the participant's sexual drive was very much better, a score of 4 indicated that the participant had experienced no change in sexual drive and a score of 7 indicated that the participant's sexual drive was very much worse. Percentage of participants = (number of participants in the category) / (total number of participants who responded to the questionnaire) \* 100.
Time frame: Study Days 15, 22, 36, 43, 57, 64 and endpoint
Population: All enrolled participants who received at least 1 dose of study drug and responded to PGI-I sexual drive questionnaire at specified time points. Endpoint is defined as the last non-missing PGI-I scale for sexual drive collected from Day 15 through end of study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Very much worse - Day 15 (n=76) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Much worse - Day 22 (n=76) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Much better - Endpoint (n=77) | 27.27 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Very much better - Day 15 (n=76) | 3.95 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Much better - Day 15 (n=76) | 11.84 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | A little better - Day 15 (n=76) | 44.74 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | No change - Day 15 (n=76) | 38.16 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | A little worse - Day 15 (n=76) | 1.32 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Much worse - Day 15 (n=76) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Very much better - Day 22 (n=76) | 5.26 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Much better - Day 22 (n=76) | 25.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | A little better - Day 22 (n=76) | 39.47 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | No change - Day 22 (n=76) | 30.26 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | A little worse - Day 22 (n=76) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Very much worse - Day 22 (n=76) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Very much better - Day 36 (n=22) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Much better - Day 36 (n=22) | 22.73 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | A little better - Day 36 (n=22) | 45.45 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | No change - Day 36 (n=22) | 31.82 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | A little worse - Day 36 (n=22) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Much worse - Day 36 (n=22) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Very much worse - Day 36 (n=22) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Very much better - Day 43 (n=22) | 4.55 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Much better - Day 43 (n=22) | 22.73 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | A little better - Day 43 (n=22) | 36.36 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | No change - Day 43 (n=22) | 31.82 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | A little worse - Day 43 (n=22) | 4.55 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Much worse - Day 43 (n=22) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Very much worse - Day 43 (n=22) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Very much better - Day 57 (n=6) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Much better - Day 57 (n=6) | 50.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | A little better - Day 57 (n=6) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | No change - Day 57 (n=6) | 50.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | A little worse - Day 57 (n=6) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Much worse - Day 57 (n=6) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Very much worse - Day 57 (n=6) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Very much better - Day 64 (n=6) | 16.67 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Much better - Day 64 (n=6) | 33.33 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | A little better - Day 64 (n=6) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | No change - Day 64 (n=6) | 50.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | A little worse - Day 64 (n=6) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Much worse - Day 64 (n=6) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Very much worse - Day 64 (n=6) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Very much better - Endpoint (n=77) | 7.79 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | A little better - Endpoint (n=77) | 35.06 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | No change - Endpoint (n=77) | 28.57 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | A little worse - Endpoint (n=77) | 1.30 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Much worse - Endpoint (n=77) | 0.00 percentage of participants |
| Topical Testosterone Solution | Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive | Very much worse - Endpoint (n=77) | 0.00 percentage of participants |