Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Men

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02432261

Run by

Kimberly Myer

People needed

44

Starts

2015-04-01

Expected to finish

2016-03-01

Last updated by the study team

2025-02-13

Who can join

Age: 18 and older, up to 50. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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;
• Does not meet any of the exclusion criteria.
• Sperm concentration ≥ 15 million sperm per milliliter ejaculate.

You may not qualify if…

• 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;
• Diastolic blood pressure (DBP) > 80 and/or Systolic (SBP) > 130 mm Hg;
• EKG abnormal and clinically significant and QTC level longer than 450msec;
• History of hypertension, including hypertension controlled with treatment;
• Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis;
• Known hypersensitivity to progestins or androgen;
• Family or personal history of venous thromboembolism;
• Benign or malignant liver tumors; active liver disease;
• Known history of reproductive dysfunction including vasectomy or infertility;
• Known history of cardiovascular, renal, hepatic or prostatic disease;
• A serious systemic disease such as diabetes mellitus or morbid obesity (body weight greater than 120% of ideal body weight or BMI limitation as above);
• Known or suspected alcoholism or drug abuse that may affect metabolism/transformation of steroid hormones and study treatment compliance;
• Known dermatitis or severe skin disorder;
• Moderate or severe depression as determined by PHQ-9 score >15;
• Partner is known to be pregnant;
• Known or suspected breast or prostate cancer;
• Allergic to any ingredient in testosterone/nestorone gel, including alcohol;
• Known history of untreated sleep apnea;
• International Prostate Symptom Score (IPSS) greater than or equal to 15.

Where it is running

• LA Biomedical Research Institute — Torrance, California, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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