Study of the Safety, and Sperm and Gonadotropin Suppression of a Contraceptive Gel in Normal Men (CCN007)

Health Decisions

Status and phase: Completed; Phase 1

Conditions: Contraception

Treatments: Drug: Testosterone; Drug: Nestorone®

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00891228

CCN007

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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
7. Does not meet any of the exclusion criteria.

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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99 participants in 3 patient groups, including a placebo group

Testosterone Gel 10 g and Nestorone® 0 mg per day

Placebo Comparator group

Description:

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.

Treatment:

Drug: Nestorone®

Drug: Testosterone

Drug: Nestorone®

Drug: Nestorone®

Testosterone Gel 10 g and Nestorone® 8 mg per day

Experimental group

Description:

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.

Treatment:

Drug: Nestorone®

Drug: Testosterone

Drug: Nestorone®

Drug: Nestorone®

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

Experimental group

Description:

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.

Treatment:

Drug: Nestorone®

Drug: Testosterone

Drug: Nestorone®

Drug: Nestorone®