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

• ClinicalTrials.gov Identifier: NCT00891228
• Recruitment Status: Completed
• First Posted: May 1, 2009
• Results First Posted: May 24, 2018
• Last Update Posted: May 24, 2018
• Sponsor: Health Decisions
• Collaborators: Population Council; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): Health Decisions

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Contraception	Drug: Testosterone; Drug: Nestorone®	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 99 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: A Multicenter, Randomized, Double-Blind Comparator Trial of the Safety and Sperm and Gonadotropin Suppression Resulting From Combined Use of Nestorone® Gel (0, 8 or 12 mg NES) and Testosterone Gel (10 g) Compared With Testosterone Gel in Normal Men
• Study Start Date: May 2009
• Actual Primary Completion Date: May 2010
• Actual Study Completion Date: November 2011

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: 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.	Drug: 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.; 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.
Experimental: 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.	Drug: 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.; 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.
Experimental: 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.	Drug: 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.; 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.

Outcome Measures

Primary Outcome Measures :

1. The Number of Men Who Have Suppression of Sperm Production ≤1Million/mL Million/mL When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel Applied Transdermally. [ Time Frame: 24 Weeks ]

Secondary Outcome Measures :

1. The Number of Men Who Have Suppression of Sperm Production ≤3 Million/mL ≤ 3 Million/mL or Azoospermia When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel. [ Time Frame: 24 Weeks ]
2. The Number of Men Who Have Azoospermia [ Time Frame: 24 Weeks ]
3. The Impact on Sperm Motility in Men Who Are Not Azoospermic Azoospermic. [ Time Frame: 24 Weeks ]
4. The Impact on Sperm Morphology in Men Who Are Not Azoospermic [ Time Frame: 24 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, California

Los Angeles Biomedical Research Institute at Harbor-UCLA

Torrance, California, United States, 90502

United States, Washington

University of Washington

Seattle, Washington, United States, 98195

Sponsors and Collaborators

Health Decisions

Population Council

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

Investigators

• Principal Investigator: Christina Wang, MD; LA BioMedical Research Institute, Harbor-UCLA
• Principal Investigator: William Bremner, MD, PhD; University of Washington

More Information

• Responsible Party: Health Decisions
• ClinicalTrials.gov Identifier: NCT00891228
• Other Study ID Numbers: CCN007
• First Posted: May 1, 2009
• Results First Posted: May 24, 2018
• Last Update Posted: May 24, 2018
• Last Verified: April 2018

Keywords provided by Health Decisions:

Contraception; Male Contraception; Suppression of Sperm Production

Additional relevant MeSH terms:

ST 1435; Testosterone; Androgens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female