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| ID | Type | Description | Link |
|---|---|---|---|
| I5E-US-TSBC | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Testosterone Solution | Experimental | Topical Testosterone Solution 30 milligrams up to 120 milligrams per day (mg/day) administered topically to axillae titrated based on testosterone levels. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Testosterone Solution | Drug | Administered topically to axillae. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline through Study Completion (Up to 9 Weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Serum Testosterone Levels | Serum testosterone levels were measured by LC/MS-MS. | Baseline, Study Completion (Up to 9 Weeks) |
| Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Encinitas | California | 92024 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Topical Testosterone Solution | Testosterone, initially 60 milligrams (mg) once daily (QD), titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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. |
| Study Days 15, 22, 36, 43, 57, 64 and endpoint |
| 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. | Study Days 15, 22, 36, 43, 57, 64 and endpoint |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Diego | California | 92103 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Parker | Colorado | 80134 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Gainesville | Georgia | 30501 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Coeur d'Alene | Idaho | 83814 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Anderson | Indiana | 46011 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Jeffersonville | Indiana | 47130 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Billings | Montana | 59101 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Elkhorn | Nebraska | 68022 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Marlton | New Jersey | 08053 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Garden City | New York | 11530 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Poughkeepsie | New York | 12601 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cary | North Carolina | 27518 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Concord | North Carolina | 28025 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Salisbury | North Carolina | 28144 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Knoxville | Tennessee | 37920 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Austin | Texas | 78731 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Marshall | Texas | 75670 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Round Rock | Texas | 78681 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Antonio | Texas | 78228 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Seattle | Washington | 98104 | United States |
| Received at Least 1 Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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All enrolled participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All enrolled participants who received at least 1 dose of study drug and had serum testosterone level measurement. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline through Study Completion (Up to 9 Weeks) |
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| Secondary | Change From Baseline in Serum Testosterone Levels | Serum testosterone levels were measured by LC/MS-MS. | 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. | Posted | Mean | Standard Deviation | ng/dL | Baseline, Study Completion (Up to 9 Weeks) |
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| 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. | 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. | Posted | Number | percentage of participants | Study Days 15, 22, 36, 43, 57, 64 and endpoint |
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| 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. | 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. | Posted | Number | percentage of participants | Study Days 15, 22, 36, 43, 57, 64 and endpoint |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 78 | 22 | 78 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Application site pain | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Irritability | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Allergy to animal | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Blood pressure decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
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| Blood pressure diastolic abnormal | Investigations | MedDRA 16.1 | Systematic Assessment |
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| Blood pressure diastolic decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 16.1 | Systematic Assessment |
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| Blood pressure systolic decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
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| Heart rate decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
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| Heart rate increased | Investigations | MedDRA 16.1 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 16.1 | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Acrochordon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Testicular atrophy | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D043343 | Testosterone Propionate |
| ID | Term |
|---|---|
| D013739 | Testosterone |
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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