Study of the Safety, and Sperm and Gonadotropin Suppression of a Contraceptive Gel in Normal Men

NCT ID: NCT00891228

Last Updated: 2018-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-11-30

Brief Summary

To determine the number of men who have suppression of sperm production when using a daily regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel applied transdermally.

Conditions

Contraception

Study Design

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

Study Groups

Testosterone Gel 10 g and Nestorone® 0 mg per day

Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.

Group Type: PLACEBO_COMPARATOR

Testosterone

Intervention Type: DRUG

Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.

Nestorone®

Intervention Type: DRUG

Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.

Testosterone Gel 10 g and Nestorone® 8 mg per day

Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg NES mL gel) by pressing two times with 2 mL dispenser head.

Group Type: EXPERIMENTAL

Testosterone

Intervention Type: DRUG

Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.

Nestorone®

Intervention Type: DRUG

Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head.

Testosterone Gel 10 g plus Nestorone® Gel 12 mg per day

Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.

Group Type: EXPERIMENTAL

Testosterone

Intervention Type: DRUG

Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.

Nestorone®

Intervention Type: DRUG

Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.

Interventions

Testosterone

Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.

Intervention Type: DRUG

Nestorone®

Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head.

Intervention Type: DRUG

Nestorone®

Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.

Intervention Type: DRUG

Nestorone®

Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Men who meet all the following criteria are eligible for enrollment in the trial:

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, use double-barrier contraception) 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

Men who meet any of the following criteria are NOT eligible for enrollment in the trial:

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 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. Other abnormal lab values may also be exclusionary, at the discretion of the investigator

6. Sperm concentration below 15 million/mL in more than one of three screening samples

7. Use of androgens or body building substances within 6 months before first screening visit

8. Diastolic (D) blood pressure (BP) ≥ 85 and Systolic (S) BP ≥ 135 mm Hg; (BP will be taken 3 times at 5 minute intervals and the mean of all measurements be considered)

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

12. Family or personal history of venous thromboembolism

13. Benign or malignant liver tumors; active liver disease

14. History of breast carcinoma

15. Known history of reproductive dysfunction including vasectomy or infertility

16. Known history of cardiac, renal, hepatic or prostatic disease

17. 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)

18. History of sleep apnea

19. Known or suspected alcoholism or drug abuse that may affect metabolism/transformation of steroid hormones and study treatment compliance

20. Known dermatitis or severe skin disorder

21. Partner is known to be pregnant

22. Men desiring fertility within the first 24 weeks of study participation.

Men participating in competitive sports where drug screening for prohibited substances (including anabolic steroids) is routine will be advised of the relative and temporary hazards that participating in this study may have for their fertility or sporting status.

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

Sponsors

Population Council

OTHER

Sponsor Role: collaborator

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

NIH

Sponsor Role: collaborator

Premier Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christina Wang, MD

Role: PRINCIPAL_INVESTIGATOR

LA BioMedical Research Institute, Harbor-UCLA

William Bremner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Los Angeles Biomedical Research Institute at Harbor-UCLA

Torrance, California, United States

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

CCN007

Identifier Type: -

Identifier Source: org_study_id