Clinical trial NCT00891228: Study of the Safety, and Sperm and Gonadotropin Suppression of a Contraceptive Gel in Normal Men
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Contraception
Keywords: Contraception
Male Contraception
Suppression of Sperm Production
Lead sponsor: Health Decisions
Sponsor class: OTHER
Collaborators: name: Population Council
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2009-05-01
Enrollment: 99
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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
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.

Primary outcomes:
measure: 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.
timeFrame: 24 Weeks
Secondary outcomes:
measure: 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.
timeFrame: 24 Weeks
measure: The Number of Men Who Have Azoospermia
timeFrame: 24 Weeks
measure: The Impact on Sperm Motility in Men Who Are Not Azoospermic Azoospermic.
timeFrame: 24 Weeks
measure: The Impact on Sperm Morphology in Men Who Are Not Azoospermic
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Los Angeles Biomedical Research Institute at Harbor-UCLA
state: California
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: LA BioMedical Research Institute, Harbor-UCLA
name: Christina Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: William Bremner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: