Study Design and Objectives
The objectives of this study were to evaluate the safety and efficacy of Androxal administered orally once daily for one year in men with secondary hypogonadism. The study design included an open-label safety study with a six-month active dosing period, assessing physical and visual acuity, laboratory tests, and adverse event reporting.
Enclomiphene Citrate (Androxal) in Testosterone-Deficient Men
Enclomifene, also known as Enclomiphene, is a novel oral drug that acts by blocking estrogen receptors and stimulating gonadotropin secretion in men diagnosed with secondary hypogonadism. This medication has been subject to clinical trials to assess its efficacy in increasing serum testosterone levels in individuals with this condition. Enclomiphene citrate, marketed as Androxal, has been evaluated to determine its impact on restoring normal pituitary and testosterone levels in men with secondary hypogonadism. Clinical studies have been performed to compare the safety and efficacy of Androxal with Clomiphene Citrate, a commonly used treatment for male infertility.
Safety and Efficacy Assessment
The safety and efficacy of Androxal in men with secondary hypogonadism were evaluated through a phase III, open-label safety study with a six-month active dosing period. Physical and visual acuity exams, slit lamp eye exams, clinical laboratory tests, DEXA scanning, and adverse event reporting were conducted to assess the safety profile. Efficacy assessments included monitoring changes in total morning testosterone levels, LH and FSH levels, fasting plasma glucose, BMI, and sperm concentration. The study aimed to provide a comprehensive analysis of the safety and efficacy of Androxal in this patient population.
Investigational Review Board Approval for Phase III Study
Zonagen has obtained investigational review board (IRB) approval to conduct a Phase III study on Androxal, a once-daily oral therapy designed for the treatment of testosterone deficiency resulting from secondary hypogonadism. The approval granted by the IRB allows the initiation of a comprehensive examination of both the safety profile and the efficacy of Androxal in restoring normal pituitary and testosterone levels in men diagnosed with this condition. This regulatory approval marks a significant step forward in the clinical development of Androxal as a potential therapeutic option for individuals with secondary hypogonadism.
Additional Year of Treatment for Study Participants
Participants who successfully completed the initial phase of the Androxal safety study, known as ZA-003, were eligible to receive an additional year of treatment in an extension study. This extension study aimed to further evaluate the safety and efficacy of Androxal in men with secondary hypogonadism. Eligible participants were given the opportunity to continue treatment beyond the initial trial period, providing valuable insights into the longer-term effects of Androxal on testosterone levels and other relevant health parameters.
Comparative Analysis with Clomiphene Citrate
Enclomiphene citrate, marketed as Androxal, is an oral drug that acts as an estrogen receptor blocker and stimulates gonadotropin secretion in men with secondary hypogonadism. Clinical trials have been conducted to evaluate the efficacy and safety of Androxal in increasing serum testosterone levels in individuals with this condition. Comparative analyses with Clomiphene Citrate, a commonly used treatment for male infertility, have been performed to assess the relative effectiveness and safety profiles of these medications in managing testosterone deficiency resulting from secondary hypogonadism.
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