Clinical trial: TDSM- Testosterone Dose Response in Surgically Menopausal Women (NCT00494208)

Eligibility criteria:
Inclusion Criteria

          -  Medically stable, ambulatory, surgically menopausal women, 21-60 years of age, who
             have undergone bilateral salpingo-oophorectomy and hysterectomy at least 6 months
             before study entry

          -  Serum total testosterone concentrations less than 31 ng/dL or free testosterone less
             than 3.5 pg/ml (less than the median for healthy, young women

          -  Able to understand and give informed consent.

          -  The women will have been on a stable regimen of transdermal estrogen replacement for
             at least three months. Those who are not on estrogen replacement or are taking a
             different mode of estrogen replacement will be included only if they are willing to
             switch to transdermal estradiol patch (see below).

          -  A normal PAP smear (if subject has a cervix) and mammogram in the preceding 12 months.

        Exclusion Criteria:

          -  Significant depression, as assessed by Beck's Depression Scale.

          -  Any acute or chronic illness, malignant disease or fever of known or unknown origin
             will be excluded.

          -  Poorly controlled diabetes mellitus (hemoglobin A1c greater than 8.5%)

          -  Uncontrolled hypertension defined as blood pressure of greater than 160/100

          -  Severe obesity defined as body mass index of greater than 40 kg/m2

          -  Current or recent (last 6 months) users of illicit drugs (which may affect appetite,
             food intake, metabolism, and/or compliance with the protocol)

          -  Any one planning to initiate a weight-reduction diet in the subsequent six months

          -  Alcohol or drug dependence currently or in the preceding 6 month.

          -  Significant liver function abnormalities, defined as SGOT, SGPT or alkaline
             phosphatase value of greater than three times the upper limit of normal in our
             Clinical Pathology Laboratory or serum bilirubin levels of greater than 1.5 mg/dl will
             be excluded.

          -  History of breast, ovarian, endometrial or cervical cancer

          -  History of hyperandrogenic disorders such as hirsutism, grade 2 or 3 acne, and
             polycystic ovary disease. Testosterone administration to these patients may exacerbate
             the underlying disorder.

          -  Intolerance to other transdermal formulations

          -  Women with abnormal PAP smears or mammograms will not be included unless they have
             been evaluated by their gynecologists and breast and uterine/cervical cancers have
             been excluded by appropriate tests.

          -  Women with dementia as assessed by the mini-mental state examination

          -  Women with depression, assessed by Beck's Depression Scale.

          -  Those with disabilities that would prevent them from participating in strength testing
             (e.g., amputation of limbs, blindness, severe arthritis, neurologic disorders such as
             Parkinson's disease, stroke, or myopathy).

          -  Women with any heart disease, including angina, congestive heart failure, or history
             of myocardial infarction or coronary artery angioplasty or bypass surgery in the
             previous year will be excluded.

          -  Subjects planning to initiate a weight-reduction diet in the subsequent six months

          -  Other Medications. Women who have received in the preceding three months drugs known
             to affect testosterone production or metabolism such as ketoconazole, Megace, and/or
             anabolic/androgenic steroids will be excluded. We will also exclude women who are
             taking or have taken in the past three months medication that include sexual
             dysfunction (e.g., spironolactone, SSRIs, GnRH agonists). Women who are using any
             medication, device or dietary supplement known to enhance sexual function will not be
             included. Women receiving thyroid hormone replacement therapy may participate in the
             study only if they have been on a stable replacement dose of L-thyroxine for at least
             three months.

          -  Intolerance to estrogen products or skin patches

          -  Undiagnosed vaginal or vulvar bleeding

          -  History of deep vein thrombosis, pulmonary embolism, or other thromboembolic disorder
Female
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 60 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