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

This study has been completed.
Sponsor:
Collaborator:
Population Council
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00891228
First received: April 30, 2009
Last updated: December 14, 2012
Last verified: April 2012

April 30, 2009
December 14, 2012
May 2009
May 2010   (final data collection date for primary outcome measure)
To determine the number of men who have suppression of sperm production ≤1 million/mL when using a daily regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel applied transdermally. [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
To determine the number of men who have suppression of sperm production ≤1 million/mL when using a daily regimen of Nestorone Gel (0, 8 or 12 mg) and Testosterone Gel applied transdermally. [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00891228 on ClinicalTrials.gov Archive Site
  • To determine the number of men who have suppression of sperm production ≤ 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 ] [ Designated as safety issue: Yes ]
  • To determine the level of suppression of gonadotropins caused by transdermal usage of Testosterone Gel and 0, 8, or 12 mg Nestorone® Gel and to correlate the level of gonadotropin suppression with sperm suppression. [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
  • To evaluate the impact on sperm morphology and motility in men who are not azoospermic. [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
  • To determine the number of men who have suppression of sperm production ≤ 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 ] [ Designated as safety issue: Yes ]
  • To determine the level of suppression of gonadotropins caused by transdermal usage of Testosterone Gel and 0, 8, or 12 mg Nestorone Gel and to correlate the level of gonadotropin suppression with sperm suppression. [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
  • To evaluate the impact on sperm morphology and motility in men who are not azoospermic. [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study of the Safety, and Sperm and Gonadotropin Suppression of a Contraceptive Gel in Normal Men
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Contraception
  • 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.
  • 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.
  • 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.
  • 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.
    Interventions:
    • Drug: Testosterone
    • Drug: Nestorone®
  • 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.
    Interventions:
    • Drug: Testosterone
    • Drug: Nestorone®
  • 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.
    Interventions:
    • Drug: Testosterone
    • Drug: Nestorone®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
November 2011
May 2010   (final data collection date for primary outcome measure)

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.

Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00891228
HSN275200800042U
Yes
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Population Council
Principal Investigator: Christina Wang, MD LA BioMedical Research Institute, Harbor-UCLA
Principal Investigator: William Bremner, MD, PhD University of Washington
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP