M16-100 (Traverse) Study

Inclusion Criteria

1. Men whose age is between 45 and 80 years, inclusive, at the time of Screening.
2. Meet the study definition of clinical hypogonadism as evidenced by:
a) Two serum testosterone levels < 300 ng/dL confirmed by fasting blood samples
drawn at least 48 hours apart.These samples should be obtained between 5 AM
and 11 AM local time.
AND
b) Presence of at least one sign or symptom that may be related to low testosterone
values and is/are consistent with hypogonadism such as the following:
● Decreased sexual desire or libido
● Decreased spontaneous erections (e.g., morning erections)
● Decreased energy or fatigue/feeling tired
● Low mood or depressed mood
● Loss of body (axillary and pubic) hair or reduced shaving
● Hot flashes

Exclusion Criteria

1. Congenital or acquired hypogonadism for whom long-term therapy with placebo
would not be medically appropriate.
2. Two testosterone levels < 100 ng/dL during Screening.
3. Current or recurrent ulcer, erosion, lichenification, inflammation psoriasis, eczema
or use of topical cortiosteroids on the upper arms and shoulders. Tattoo application
or removal in the region of study drug application within 6 months of Screening.
4. Known skin intolerance to alcohol or allergy to any of the ingredients of the study
drug (see AndroGel 1.62% prescribing information).
5. History of treatment with growth hormone, anti-estrogen or estrogen treatment
within 90 days prior to Screening.

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Our staff is available to answer ANY questions that you may have about the process of participating in a clinical trial.
We do our absolute best to work with your busy schedules to accommodate study visits that are best for you.

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Phone: (954) 582-7007
Fax: (954) 580-8085

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information@sfwcri.com

Address

2964 N State Road 7, Suite
200 Margate, FL 33063