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

Kimberly Myer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Testosterone only gel; Drug: Nestorone® /testosterone gel

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02432261

CCN005A

Details and patient eligibility

About

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.

Full description

A total of 45 subjects will be enrolled and randomized in a 2:1 ratio to one of two treatment groups. A description of each group is as follows:

• Group 1 (30 subjects): 5.0 mL of the 1.62% combined gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders
• Group 2 (15 subjects): 4.4 mL of the 1.62% AndrogelTM (containing 62.7 mg T) applied each day to the arms and shoulders

The total duration of treatment will be 28 days followed by a 72 hour sampling period to assess half-life and a recovery period of at least 28 days, at which point the subjects will return to the clinic for an end of study visit.

Enrollment: 44 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 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;
2. 18 to 50 years of age;
3. BMI < 33 calculated as weight in Kg/(height in cm)2;
4. No history of hormonal therapy use in the last six months prior to the first screening visit;
5. 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;
6. In the opinion of the investigator, subject is able to comply with the protocol, understand and sign an informed consent and HIPAA form;
7. Does not meet any of the exclusion criteria.
8. Sperm concentration ≥ 15 million sperm per milliliter ejaculate.

Exclusion criteria

1. Men participating in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit;
2. Men not living in the catchment's area of the clinic or within a reasonable distance from the site;
3. Clinically significant abnormal physical findings at screening;
4. Elevated PSA (levels ≥ 4 ng/mL), according to local laboratory normal values;
5. Abnormal serum chemistry values, according to local laboratory normal values that indicate liver or kidney dysfunction or that may be considered clinically significant;
6. Use of androgens or body building substances within 6 months before first screening visit;
7. Diastolic blood pressure (DBP) > 80 and/or Systolic (SBP) > 130 mm Hg;
8. EKG abnormal and clinically significant and QTC level longer than 450msec;
9. History of hypertension, including hypertension controlled with treatment;
10. Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis;
11. Known hypersensitivity to progestins or androgen;
12. Family or personal history of venous thromboembolism;
13. Benign or malignant liver tumors; active liver disease;
14. Known history of reproductive dysfunction including vasectomy or infertility;
15. Known history of cardiovascular, renal, hepatic or prostatic disease;
16. 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);
17. Known or suspected alcoholism or drug abuse that may affect metabolism/transformation of steroid hormones and study treatment compliance;
18. Known dermatitis or severe skin disorder;
19. Moderate or severe depression as determined by PHQ-9 score >15;
20. Partner is known to be pregnant;
21. Known or suspected breast or prostate cancer;
22. Allergic to any ingredient in testosterone/nestorone gel, including alcohol;
23. Known history of untreated sleep apnea;
24. International Prostate Symptom Score (IPSS) greater than or equal to 15.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups

Group 1

Experimental group

Description:

5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders

Treatment:

Drug: Nestorone® /testosterone gel

Group 2

Experimental group

Description:

4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders

Treatment:

Drug: Testosterone only gel