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| ID | Type | Description | Link |
|---|---|---|---|
| I5E-MC-TSBD | Other Identifier | Eli Lilly and Company |
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This study will evaluate the effect of deodorant and antiperspirant use and the presence of underarm hair on the absorption of testosterone. Each participant in this study will receive 6 single doses of 30 milligrams (mg) testosterone applied as a solution to each underarm. There is a minimum one day washout period between each dose. This study will last approximately 24 days not including screening. Screening is required within 30 days prior to the start of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testosterone Unshaved | Experimental | No deodorant or antiperspirant: Single 30 mg dose of testosterone applied topically to each unshaved axilla in 1 of 6 treatment periods. |
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| Testosterone Unshaved + Deodorant Spray | Experimental | Deodorant spray applied to unshaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods. |
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| Testosterone Unshaved + Deodorant Antiperspirant Spray | Experimental | Deodorant antiperspirant combination spray applied to unshaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods. |
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| Testosterone Unshaved + Deodorant Antiperspirant Stick | Experimental | Deodorant antiperspirant combination stick applied to unshaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods. |
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| Testosterone Shaved |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone | Drug | Administered topically to axillae |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone | The AUC from time 0 to 72 hours [AUC (0-72)] postdose, based on baseline-corrected concentrations. Baseline-corrected AUC (0-72) was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations. | Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drug |
| Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone | The Cmax from time 0 to 72 hours postdose, based on baseline-corrected concentrations. Baseline-corrected Cmax was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations. | Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drug |
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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 9 AM - 5 PM 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. | Daytona Beach | Florida | 32117 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25123988 | Derived | Small DS, Ni X, Polzer P, Vart R, Satonin DK, Mitchell MI. Effect of deodorant and antiperspirant use and presence or absence of axillary hair on absorption of testosterone 2% solution applied to men's axillae. J Sex Med. 2014 Nov;11(11):2809-17. doi: 10.1111/jsm.12658. Epub 2014 Aug 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | 30-milligram (mg) testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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No deodorant or antiperspirant: Single 30 mg dose of testosterone applied topically to each shaved axilla in 1 of 6 treatment periods. |
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| Testosterone Shaved + Deodorant Antiperspirant Spray | Experimental | Deodorant antiperspirant combination spray applied to shaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods. |
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| Deodorant Spray | Other | Administered topically to axillae |
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| Deodorant and Antiperspirant Combination Spray | Other | Administered topically to axillae |
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| Deodorant and Antiperspirant Combination Stick | Other | Administered topically to axillae |
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| 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. | Evansville | Indiana | 47710 | United States |
| FG001 | Sequence 2 | 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 5, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment. |
| FG002 | Sequence 3 | 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment. |
| FG003 | Sequence 4 | 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment. |
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| Washout From Period 1 |
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| Period 2 |
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| Washout From Period 2 |
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| Period 3 |
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| Washout From Period 3 |
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| Period 4 |
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| Washout From Period 4 |
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| Period 5 |
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| Washout From Period 5 |
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| Period 6 |
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All randomized participants who received at least 1 dose of testosterone 2% solution.
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| ID | Title | Description |
|---|---|---|
| BG000 | Testosterone 2% Solution | Participants randomized to 1 of 4 treatment sequences involving 6 treatments in each sequence. Each sequence involved 4 single-dose treatments of testosterone 2% solution to unshaved axillae with or without the use of deodorant or antiperspirant products followed by 2 single-dose treatments of testosterone 2% solution to shaved axillae with or without the use of deodorant or antiperspirant products. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment. |
| 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 | |||||||||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Screening Testosterone | Mean | Standard Deviation | nanograms per deciliter (ng/dL) |
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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 | |||||||||||||||||||||||||||||||||||
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| Primary | Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone | The AUC from time 0 to 72 hours [AUC (0-72)] postdose, based on baseline-corrected concentrations. Baseline-corrected AUC (0-72) was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations. | All randomized participants who received at least 1 dose of testosterone 2% solution and had evaluable 72-hour testosterone concentrations. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms* hours per deciliter (ng*h/dL) | Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drug |
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| Primary | Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone | The Cmax from time 0 to 72 hours postdose, based on baseline-corrected concentrations. Baseline-corrected Cmax was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations. | All randomized participants who received at least 1 dose of testosterone 2% solution for the specified treatment regimen. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per deciliter (ng/dL) | Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drug |
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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 | Testosterone Unshaved | No deodorant or antiperspirant. A single 30-milligram (mg) dose of testosterone 2% solution applied topically to each unshaved axilla. | 0 | 29 | 3 | 29 | ||
| EG001 | Testosterone Unshaved + Deodorant Spray | Deodorant spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution. | 0 | 29 | 1 | 29 | ||
| EG002 | Testosterone Unshaved + Deodorant Antiperspirant Spray | Deodorant antiperspirant combination spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution. | 0 | 29 | 2 | 29 | ||
| EG003 | Testosterone Unshaved + Deodorant Antiperspirant Stick | Deodorant/antiperspirant combination stick applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution. | 0 | 28 | 4 | 28 | ||
| EG004 | Testosterone Shaved | No deodorant or antiperspirant. A single 30-mg dose of testosterone 2% solution applied topically to each shaved axilla. | 0 | 26 | 0 | 26 | ||
| EG005 | Testosterone Shaved + Deodorant Antiperspirant Spray | Deodorant/antiperspirant combination spray applied to each shaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution. | 0 | 26 | 0 | 26 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Nodule | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D013739 | Testosterone |
| D043343 | Testosterone Propionate |
| D003836 | Deodorants |
| ID | Term |
|---|---|
| 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 |
| D003358 | Cosmetics |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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| Adverse Event |
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| White |
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| OG003 | Testosterone Unshaved + Deodorant Antiperspirant Stick | Deodorant/antiperspirant combination stick applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution. |
| OG004 | Testosterone Shaved | No deodorant or antiperspirant. A single 30-mg dose of testosterone 2% solution applied topically to each shaved axilla. |
| OG005 | Testosterone Shaved + Deodorant Antiperspirant Spray | Deodorant/antiperspirant combination spray applied to each shaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution. |
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