Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES… (NCT02994602) | Clinical Trial Compass
CompletedPhase 1
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
United States26 participantsStarted 2017-01
Plain-language summary
This is a two-center, open-label study conducted in healthy male and female volunteers at two academic research centers. The study will consist of three single applications of the Nestorone (NES) + testosterone (T) combined gel on the shoulders/upper arms of male participants followed 2 hours later by supervised skin contact by the non-dosed female participants on the application site on days 1, 8, and 15. Effect of Washing or Clothing Barrier to the Application will be assessed.
Who can participate
Age range18 Years – 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 \< 35 kg/m2;
✓. No history of androgen use prior to the first screening visit as follows:
✓. 1 month prior for oral or transdermal androgen,
✓. 3 months prior for Testosterone cypionate or enanthate injection,
✓. 6 months prior for Testosterone undecanoate injection;
✓. Agreement to use a recognized effective method of short acting contraception with his partner (i.e. at a minimum use double-barrier method such as a condom with spermicide) during the entire study;
Exclusion criteria
✕. Men participating in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit.
What they're measuring
1
Changes From Baseline (Cavg) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel
Timeframe: Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)
2
Changes From Baseline (Cmin) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel
Timeframe: Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)
3
Changes From Baseline (Cmax) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel
Timeframe: Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)
4
Changes From Baseline (Cmin) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel
Timeframe: Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)
5
Changes From Baseline (Cmax) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel
Timeframe: Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)
✕. Men not living in the catchment area of the study site or within a reasonable travel time from the site.
✕. Any clinically significant abnormal findings at screening per the Investigator's medical judgement.
✕. Elevated PSA (e.g. levels ≥ 4 ng/mL), according to study site's local laboratory reference normal values for adult men.
✕. Abnormal serum chemistry values that may indicate clinically significant liver or kidney dysfunction. Other abnormal laboratory values may also be exclusionary, if so considered by the investigator to be clinically significant.
✕. Use of androgens or other anabolic steroids that may affect testosterone measurements
✕. Diastolic blood pressure (DBP) ≥ 85 and Systolic blood pressure (SBP) ≥ 135 mm Hg; (BP will be taken three times at approximately 5 minute intervals and the mean of the 3 measurements will be considered).
✕. History of hypertension (well-controlled treated hypertension (\< 135/85) is allowed).
Changes From Baseline (Cavg) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel
Timeframe: Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)