Active Ingredient: Clomiphene
The AIDS Healthcare Foundation last week announced that a fourth performer had tested positive, even though an FSC statement on Monday suggested there had been no additional positive tests beyond the original three.
Institutional review board or independent ethics committee approvals were obtained at each centre, all patients provided written informed consent, and the study was conducted in accordance with the Declaration of Helsinki and principles of good clinical practice.
Subjects agreed to use a condom or another form of contraception during the study.
Subjects with diabetes, hyperprolactinaemia, HIV, cataracts, breast or prostate cancer, end-stage renal disease, cystic fibrosis, uncontrolled hypertension, abnormal haemoglobin or heamatocrit, or subjects using medications known to interfere with sex steroid synthesis or action were excluded.
The men in each of the four study arms were randomized to one of three single-blind enclomiphene citrate doses or open label transdermal testosterone.
The doses of enclomiphene citrate in the single-blind portion of the study were enclomiphene citrate 6. Capsules were supplied by Repros Therapeutics.
Subjects receiving enclomiphene citrate were instructed to take one capsule of blinded study medication between 7:00 h and 10:00 h every day.
Transdermal testosterone was applied as per the package insert.
Subjects were instructed to apply the gel at the same time each day, and not to bathe or swim for 3—4 h after application. At visit 1 or week 2 subjects underwent screening procedures, which included signing of the consent form, a complete medical history, medication history, physical examination, blood evaluation and a slit lamp eye examination and visual acuity test.Clomid For Men - IVF 1 - Clomid, Clomiphene, Serophene Premature ejaculation pills this medicine over the counter medicine for bacterial infection mouth with a glass of water. Take exactly as directed 25 mg the exact number of days prescribed.
Eligible subjects underwent a 24-h assessment of baseline total testosterone, LH and FSH visit 2 or week 0. Blood samples were also collected to test for lipids and hormones and subjects were asked to follow a normal ad libitum diet.
Subjects received a study medication kit, containing a 2-week supply of study medication. Subjects in the enclomiphene citrate arms returned for visits at 2 and 4 weeks in the morning before 09:00 h for blood draws before 10:00 h to measure total testosterone, FSH, LH and trough levels of the study drug.
At 6 weeks, subjects underwent a 24-h assessment of total testosterone and LH.
During this time blood was also drawn for a pharmacokinetic assessment of serum enclomiphene citrate levels at 0, 2, 4, 8, 12, 16 and 24 h after a single dose of enclomiphene citrate 6.
Subjects returned at 7 weeks for a final blood draw after a 1-week washout before 10:00 h.
Statistical Analysis Statistical analysis of the primary efficacy variable was the change between day 1 and day 42 in the 24-h mean testosterone and LH levels.
An overall comparison among the four treatment groups was performed using anova or the Kruskal—Wallis test.