Study of the Safety, and Sperm and Gonadotropin Suppressi... | NCT00891228

NCT00891228

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Population Council	OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	NIH

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Testosterone Gel 10 g and Nestorone® 0 mg per day	Placebo Comparator	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 Drug: Nestorone®
Testosterone Gel 10 g and Nestorone® 8 mg per day	Experimental	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 Drug: Nestorone®
Testosterone Gel 10 g plus Nestorone® Gel 12 mg per day	Experimental	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 Drug: Nestorone®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Testosterone	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.	Testosterone Gel 10 g and Nestorone® 0 mg per day

Measure	Description	Time Frame
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.		24 Weeks

Measure	Description	Time Frame
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.		24 Weeks
The Number of Men Who Have Azoospermia		24 Weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria

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

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
18 to 50 years of age
BMI ≤ 33 calculated as weight in Kg/ (height in cm) 2
No history of hormonal therapy use in the last six months prior to the first screening visit
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
In the opinion of the investigator, subject is able to comply with the protocol, understand and sign an informed consent and HIPAA form
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:

Men participating in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit
Men not living in the catchment's area of the clinic or within a reasonable distance from the site
Clinically significant abnormal findings at screening
Elevated PSA (levels ≥ 4 ng/mL), according to local laboratory normal values
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
Sperm concentration below 15 million/mL in more than one of three screening samples
Use of androgens or body building substances within 6 months before first screening visit
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)
History of hypertension, including hypertension controlled with treatment
Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis
Known hypersensitivity to progestins
Family or personal history of venous thromboembolism
Benign or malignant liver tumors; active liver disease
History of breast carcinoma
Known history of reproductive dysfunction including vasectomy or infertility
Known history of cardiac, renal, hepatic or prostatic disease
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)
History of sleep apnea
Known or suspected alcoholism or drug abuse that may affect metabolism/transformation of steroid hormones and study treatment compliance
Known dermatitis or severe skin disorder
Partner is known to be pregnant
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.

Name	Affiliation	Role
Christina Wang, MD	LA BioMedical Research Institute, Harbor-UCLA	Principal Investigator
William Bremner, MD, PhD	University of Washington	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Los Angeles Biomedical Research Institute at Harbor-UCLA		Torrance	California	90502	United States

Arm/Group Information

ID	Title	Description
FG000	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. 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. 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.
FG001	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. 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. 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.
FG002	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. 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. 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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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. 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. 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.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Posted

Number

participants

24 Weeks

ID	Title	Description
OG000	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. 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. 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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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. 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. 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.

ID	Term
D013739	Testosterone
C029167	ST 1435

ID	Term
D000737	Androstenols
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473