Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES) + Testosterone (T) Combined Gel Applied to Shoulders and Upper Arms in Males

Inclusion Male participant - Inclusion Criteria

Men who meet all the following criteria will be eligible for enrollment in the trial:

• Good health as confirmed by medical history, physical examination, and clinical laboratory tests of blood and urine at the time of screening;
• 18 to 50 years of age;
• BMI ≥ 18 and 19).
• Known history of significant cardiac, renal, hepatic or prostatic disease.
• History of thromboembolic disease.
• A serious systemic disease such as diabetes mellitus (including diabetes controlled with treatment), HIV, or morbid obesity.
• Current active or ongoing Hepatitis infection
• Known or suspected current alcohol dependence syndrome, chronic marijuana use, or any illicit drug use that may affect metabolism/transformation of steroid hormones and study treatment compliance.
• Known active or chronic dermatitis or other severe skin disorder.
• Desiring fertility within 6 months of study participation.
• History of severe depression or other serious mental health disorder.
• Men participating in competitive sports where drug screening for prohibited substances (including anabolic steroids) is routine will be advised of the relative and temporary hazards that participating in this study may have for their sporting status.

Female participant - Exclusion Criteria

Women who meet any of the following criteria are not eligible for enrollment in the trial:

• Desire to become pregnant during the study.
• Breastfeeding
• Known or suspected current alcoholism or drug abuse.
• History of thrombosis
• Serum testosterone outside normal reference ranges by local laboratory standards or evidence of hirsutism (modified Ferriman-Galwey score > 8)
• Participation in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit.
• Current pregnancy.
• Known hypersensitivity to progestins or testosterone.
• Any clinically significant abnormal findings at screening per the Investigator's medical judgement.
• Use of androgens or other anabolic steroids that may affect testosterone measurements.
• Known active or chronic dermatitis or other severe skin disorder.
• Known or suspected current alcohol dependence syndrome, chronic marijuana use, or any illicit drug use that may affect metabolism/transformation of steroid hormones and study treatment compliance.
• Not living in the catchment area of the study site or within a reasonable travel time from the site.