Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Com… (NCT02432261) | Clinical Trial Compass
CompletedPhase 1
Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Men
United States44 participantsStarted 2015-04
Plain-language summary
This is a prospective, randomized, double-blinded, two-center trial to evaluate the gonadotropin suppressive activity of transdermal treatment with a combined NES/T gel, or T gel alone, for 28 days.
Who can participate
Age range18 Years – 50 Years
SexMALE
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Inclusion criteria
✓. Male volunteers in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine at the time of screening;
✓. 18 to 50 years of age;
✓. BMI \< 33 calculated as weight in Kg/(height in cm)2;
✓. No history of hormonal therapy use in the last six months prior to the first screening visit;
✓. Subject will agree to use a recognized effective method of contraception with his partner (i.e. at a minimum, condom for the male partner and an effective contraception for the female partner) during the course of the study treatment and recovery phase;
✓. In the opinion of the investigator, subject is able to comply with the protocol, understand and sign an informed consent and HIPAA form;
Exclusion criteria
✕. Sperm concentration ≥ 15 million sperm per milliliter ejaculate.
✕. Men participating in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit;
✕. Men not living in the catchment's area of the clinic or within a reasonable distance from the site;
✕. Clinically significant abnormal physical findings at screening;
✕. Elevated PSA (levels ≥ 4 ng/mL), according to local laboratory normal values;
. Abnormal serum chemistry values, according to local laboratory normal values that indicate liver or kidney dysfunction or that may be considered clinically significant;
✕. Use of androgens or body building substances within 6 months before first screening visit;