A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism
Condition: Hypogonadism
MeSH terms: Hypogonadism
Intervention: AndroGel 1.62%
Intervention description: AndroGel 1.62% was packaged in pump bottles with quantities sufficient to accommodate study design and could have been dose adjusted between a minimum of 20.25 mg of T (1 pump actuation) and a maximum of 81.0 mg of testosterone (4 pump actuations). For the first study drug administration at the Day 1 Visit, and also at Week 2, Week 4, Week 16 ambulatory blood pressure monitoring (ABPM,) and End of Treatment Visits, participants applied the study drug while on site so that the site staff could observe the proper administration of study drug. If participants forgot to apply their AndroGel 1.62% dose at their regularly scheduled dosing time, they were to take the next dose at the next dosing time.
Intervention MeSH terms: Testosterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 246.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypogonadism; Testosterone Replacement Therapy; AndroGel

Summary:

      Hypogonadism is an endocrine disorder characterized by absent or deficient testosterone
      levels along with signs and symptoms of androgen deficiency, including delayed development or
      regression of sexual characteristics, impaired sexual function and sense of well-being,
      depressed mood, decreased muscle strength associated with loss of muscle mass and reduced
      bone mineral density. AndroGel 1.62% has demonstrated its ability to increase total
      testosterone levels in the blood by absorption of testosterone through the skin when applied
      topically. This study evaluated the effect of AndroGel 1.62% on systolic blood pressure using
      ambulatory blood pressure monitoring in hypogonadal men who used testosterone replacement
      therapy.

      AndroGel 1.62% is a drug used for the treatment of hypogonadism, which is associated with low
      or no testosterone. This was an open-label study which means that both the study doctor and
      study participants knew what drug and what dose is being used. All participants in this study
      were in the same group, called a treatment arm. Adult male participants with hypogonadism
      were enrolled and received AndroGel 1.62%. This was a multi-center study with 190
      participants enrolled (initially planned) in approximately 45 sites in the United States to
      yield 171 subjects in the per protocol (PP) population. A blinded sample size re-estimation
      (BSSR) was performed when around 70% of the planned subjects in the PP population had
      completed the end of treatment visit. Sample size was increased at BSSR and 246 participants
      were actually enrolled.

      Participants received daily topical gel doses of AndroGel 1.62% for approximately 16 weeks.

      There may have been a higher burden for participants in this study compared to standard of
      care. Participants attended 8 study visits during the course of the study at a hospital or
      clinic and received 2 study phone calls. The effect of the treatment was checked by medical
      assessments, blood tests (including pharmacokinetic sampling), and 24-hour blood pressure
      monitors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of hypogonadism with the presence of at least one of the following symptoms
             that may be related to low testosterone values and is/are consistent with
             hypogonadism:

               -  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 AND

          -  Confirmed by 2 serum testosterone levels < 300 ng/dL by blood samples drawn at least
             48 hours apart. These samples should be obtained between 5 am and 11 am local time.

          -  Blood pressure >100/60 mmHg and <140/90 mmHg

        Exclusion Criteria:

          -  Unprovoked deep vein thrombosis (DVT), unprovoked pulmonary embolism (PE), or known
             thrombophilia

          -  Polycythemia vera or secondary polycythemia, such as polycythemia due to untreated
             sleep apnea or severe chronic obstructive pulmonary disease

          -  Prostate or breast cancer

          -  Any active malignancy

          -  Clinically significant medical conditions or any other reason that the investigator
             determines would interfere with participation in this study or would make the
             participant an unsuitable candidate to receive study drug

          -  Work night shifts or is otherwise required to perform strenuous manual labor while
             wearing the Ambulatory Blood Pressure Monitor (ABPM).