Active substances: Clomiphene
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Men who had low total testosterone values at baseline had significant increases in serum total testosterone levels after 2 weeks of treatment with enclomiphene citrate. A more recent study provided evidence that enclomiphene citrate raises testosterone levels in men with secondary hypogonadism and also preserves or improves sperm counts.
In contrast to the group receiving enclomiphene citrate, men receiving Testim had a reduction in LH and FSH levels and in sperm counts.
Patients and Methods Patients Forty-eight men were randomized to receive either: 6. These men were defined as the intent-to treat ITT population.
Four men three in the enclomiphene citrate 12. Forty-four subjects completed the study per protocol PP and were defined as the PP population. The mean sd BMI for all men was 34. There was no significant difference in age or BMI among the treatment groups.
Others variables were determined by standard laboratory methods.
Analytical procedures to determine concentrations of enclomiphene citrate in human semen were performed at Cetero Research. Protocol The present study was a randomized, single-blind, phase II, four-arm study with a 6-week active dosing period.
The objectives were to assess LH and testosterone levels in men with secondary hypogonadism. 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.