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

NCT ID: NCT02432261

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-03-31

Brief 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.

Detailed 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Group 1

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

Group Type: EXPERIMENTAL

Nestorone® /testosterone gel

Intervention Type: DRUG

Nestorone® /testosterone combined gel

Group 2

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

Group Type: EXPERIMENTAL

Testosterone only gel

Intervention Type: DRUG

Testosterone only gel

Interventions

Nestorone® /testosterone gel

Nestorone® /testosterone combined gel

Intervention Type: DRUG

Testosterone only gel

Testosterone only gel

Intervention Type: DRUG

Other Intervention Names

Androgel

Eligibility Criteria

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;

Exclusion Criteria

8. Sperm concentration ≥ 15 million sperm per milliliter ejaculate.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Kimberly Myer

OTHER

Sponsor Role: lead

Responsible Party

Kimberly Myer

Program Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Christina Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Research Site

William Bremner, MD

Role: PRINCIPAL_INVESTIGATOR

Research Site

Locations

LA Biomedical Research Institute

Torrance, California, United States

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

CCN005A

Identifier Type: -

Identifier Source: org_study_id