Clinical trial: Physiologic Testosterone Replacement in Women With Hypopituitarism (NCT00144391)

Eligibility criteria:
Inclusion Criteria:

          -  Women age 18-55

          -  Hypopituitarism with central adrenal and/or gonadal deficiencies. To qualify patients
             will need to have either 1 or 2 and they need to have 3:

               1. To diagnose central adrenal deficiency, patients not on glucocorticoid
                  replacement will have an insulin tolerance test (ITT) (patients with
                  cardiovascular disease will be excluded) in which 0.1U/kg of insulin will be
                  given by iv and a peak cortisol value of less than 20ug/dl, associated with a
                  glucose level of less than 40mg/dL will be considered consistent with central
                  adrenal insufficiency. Patients on glucocorticoid replacement will be evaluated
                  by examining their prior workup and if it is determined that they had evidence of
                  central adrenal deficiency, an ITT will not be required to document central
                  adrenal deficiency (an ITT will still be performed to determine GH deficiency).

               2. To diagnose central gonadal deficiency, patients will be asked if they had
                  amenorrhea or oligomenorrhea prior to estrogen replacement. An FAH of less than 5
                  MIU/ML will be used to confirm that they have central and not primary gonadal
                  deficiency. In select patients in which the diagnosis of central gonadal
                  deficiency is unclear, we may perform an LHRH stimulation test, in which 100 ug
                  iv of LHRH (Factrel) will be given and a peak LH response of less than 15 MIU/ML
                  will be considered consistent with central gonadotropin insufficiency.

               3. Serum testosterone level on transdermal estrogen replacement of less than 20
                  ng/dL or free testosterone of less than 1.5 pg/ml.

          -  No other significant medical condition

          -  Weight between 80 and 150% of ideal body weight

          -  Able to provide informed consent

          -  All races and ethnicities

          -  All patients regardless of marital status and relationship status.

        Exclusion Criteria:

          -  Physical disabilities that would prevent them from participating in the study.

          -  Current use of testosterone or other androgenic steroids. Patients who are taking
             testosterone, DHEA or other androgen precursors will discontinue these
             medications/supplements three months prior to the study.

          -  Significant cardiopulmonary disease (prior myocardial infarction causing ventricular
             dysfunction, angina, arrhythmias, congestive heart failure, valvular problem), venous
             thrombotic event (pulmonary embolism or deep vein thrombosis), renal disease
             (creatinine greater than 1.5 mg/dL), diabetes mellitus on insulin, uncontrolled
             hypertension, malignancy (other than basal cell skin carcinoma) or major psychiatric
             disease. Patients with depression or anxiety on a stable dose of medication will be
             allowed to enroll.

          -  Current abuse of illicit drugs or heavy ethanol use.

          -  History of breast cancer or abnormal mammogram at entry. If patients with an abnormal
             mammogram or PAP smear are appropriately evaluated and found not to have cancer, they
             will be allowed to participate in the study.

          -  Those with significant liver function abnormalities defined as SGOT, SGPT or alkaline
             phosphatase value of greater than one and one-half the upper limit of normal in our
             Clinical Pathology Laboratory or serum bilirubin levels of greater than 2 mg/dL will
             be excluded.

          -  Those with history of hyperandrogenic disorders such as hirsutism and polycystic ovary
             disease will be excluded. These conditions are rare in women with hypopituitarism.
             Testosterone administration to these patients may exacerbate the underlying disorder.

          -  Women who are pregnant, seeking to become pregnant in the next 6 months, or
             breast-feeding.

          -  Those who have previously experienced intolerance to other transdermal systems or gels

          -  Drugs known to alter testosterone production such as megace or ketoconazole.

          -  Patients with untreated hyperprolactinemia or active Cushing's disease. Patients with
             treated prolactinoma or Cushing's disease will be allowed to participate in the study.

          -  Hematocrit of greater than 50%

          -  Male sex

          -  Not willing to answer all questions on surveys

          -  EKG showing ischemia or prior myocardial infarction

          -  Patients with extensive brain surgery, severe head injury, brain tumors or other
             conditions that profoundly affect CNS function.

          -  Patients not willing to be placed on a standardized hormonal replacement regimen
             including transdermal estrogen and growth hormone.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years

Patient description (medical language): A 19-year-old male came to clinic with some sexual concern.  He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates.  On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH.

Patient description (patient's own words): I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels.

Does the patient match the trial criteria? Contradiction