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2.2. Study group 2: pharmacokinetic study, inter-individual variation in T levels
In Vismodegib separate IRB approved trial (Miami Valley Hospital, Premier Health Partners, MVH Study # 06-0090;6859), pharmacokinetic (PK) studies were performed in 12 previously untreated, postmenopausal women receiving identical doses (100 mg) of T as a subcutaneous implant. Serum T levels were measured at baseline (prior to therapy), 4 weeks and 16 weeks after T pellet insertion. BMI was calculated and correlated with serum T levels at baseline and on therapy. Written informed consent was obtained on all patients.
2.3. Study ‘group’ 3: circadian (intra-individual) variation in T levels
A 26 h PK pilot study was performed on a female patient treated with a 112.5 mg T implant. Venous bloodspot specimens were collected every 2 h during waking hours, throughout a 26 h period, 6 weeks after T pellet implantation.
3. Methodologies
3.1. Serum testosterone testing
In group 1, total testosterone levels were measured using liquid chromatography tandem mass spectrometry, LCMS (intra-assay CV 9%) or by immune-assay using Bayer Advia Centaur immunoassay (intra-assay CV 11.8%). The methodology used (IA vs. LCMS) depended on the lab, which was determined by insurance coverage.