Clinical trial: Baseline Sexual Function, Cognitive Function, Body Composition and Muscle Parameters and Pharmacokinetics of Transdermal Testosterone Gel in Women With Hypopituitarism (NCT00144404)

Eligibility criteria:
Inclusion Criteria:

          -  Women age 18-55

          -  Hypopituitarism with documented central adrenal and gonadal deficiencies. Serum
             testosterone level of < 20 ng/dl or free testosterone <1.5 pg/ml on conjugated equine
             estrogen replacement

          -  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, renal disease (creatinine > 1.5 mg/dL), diabetes
             mellitus, 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 or uterine cancer

          -  Those with significant liver function abnormalities defined as SGOT, SGPT or alkaline
             phosphatase value of greater than one and one-half times 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

          -  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 > 50%

          -  Male sex

          -  Not willing to answer all questions on surveys
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