Effects of Deodorant and Antiperspirant Use and the Presence of Axillary Hair on the Absorption of Testosterone Applied as Testosterone 2% Solution
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy males, as determined by medical history and physical examination
- •Agree to use a reliable method of birth control (for example, condom or vasectomy) during the study and for 1 month following the last dose of testosterone
- •Have a total testosterone level <400 nanograms per deciliter (ng/dL) based on local laboratory result
- •Have a hemoglobin ≥12 grams per deciliter (g/dL) at screening and, if the participant takes a break from the study, at the re-test
- •Weigh at least 60 kilograms (kg)
- •Have venous access sufficient to allow for blood sampling
- •Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
- •Have given written informed consent approved by Eli Lilly and Company (Lilly) and the ethical review board (ERB) governing the site
排除标准
- •Use any topical testosterone replacement therapy within the 2 weeks prior to randomization through the last dosing period, except for use of testosterone solution as directed by study procedures
- •Use parenteral testosterone replacement (testosterone enanthanate, testosterone cypionate) within the 30 days prior to screening. Use long-acting intramuscular testosterone undecanoate 6 months prior to screening, or use of testosterone pellets 12 months prior to screening
- •Have a body mass index >35 kilograms per square meter (kg/m^2)
- •Have a significant history of allergy and/or sensitivity to the drug products or excipients, including any history of sensitivity to testosterone
- •Currently use any medications, herbal, and/or nutritional supplements that can interfere with testosterone
- •Have a dermatologic condition in the underarm area that might interfere with testosterone absorption (for example, eczema) or be exacerbated by topical testosterone replacement therapy
- •Have a history or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, endocrine, hematological, or neurological disorders constituting a risk when taking the study medication of that could interfere with the interpretation of the data
- •Have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
- •Have an abnormal prostate-specific antigen (PSA) test result
- •Have known allergies to testosterone solution, related compounds or any components of the formulation, or history of significant atopy
- •Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
- •Have an abnormal blood pressure as determined by the investigator
- •Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- •Show evidence of hepatitis B and/or positive hepatitis B surface antigen
- •Show evidence of hepatitis C and/or positive hepatitis C antibody
- •Show evidence of human immunodeficiency (HIV) infection and/or positive human HIV antibodies
- •Are participants who have previously completed or withdrawn from this study or any other study investigating testosterone
- •Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or nonapproved 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
- •In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study
- •Have shaved the axillae within 3 months of screening
研究组 & 干预措施
Testosterone Unshaved
No deodorant or antiperspirant: Single 30 mg dose of testosterone applied topically to each unshaved axilla in 1 of 6 treatment periods.
干预措施: Testosterone (Drug)
Testosterone Unshaved + Deodorant Spray
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.
干预措施: Testosterone (Drug)
Testosterone Unshaved + Deodorant Spray
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.
干预措施: Deodorant Spray (Other)
Testosterone Unshaved + Deodorant Antiperspirant Spray
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.
干预措施: Testosterone (Drug)
Testosterone Unshaved + Deodorant Antiperspirant Spray
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.
干预措施: Deodorant and Antiperspirant Combination Spray (Other)
Testosterone Unshaved + Deodorant Antiperspirant Stick
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.
干预措施: Testosterone (Drug)
Testosterone Unshaved + Deodorant Antiperspirant Stick
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.
干预措施: Deodorant and Antiperspirant Combination Stick (Other)
Testosterone Shaved
No deodorant or antiperspirant: Single 30 mg dose of testosterone applied topically to each shaved axilla in 1 of 6 treatment periods.
干预措施: Testosterone (Drug)
Testosterone Shaved + Deodorant Antiperspirant Spray
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.
干预措施: Testosterone (Drug)
Testosterone Shaved + Deodorant Antiperspirant Spray
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.
干预措施: Deodorant and Antiperspirant Combination Spray (Other)
结局指标
主要结局
Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone
时间窗: 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
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.
Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone
时间窗: 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
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.
次要结局
未报告次要终点