Enclomiphene, a selective estrogen receptor modulator (SERM), has undergone extensive clinical evaluation to assess its safety and efficacy in various therapeutic applications. In this article, we explore the findings of key clinical trials that have investigated the use of enclomiphene in male hypogonadism, female infertility, and other conditions. By examining the results of these trials, we can gain insights into the benefits, limitations, and potential future applications of enclomiphene.

Clinical Trial 1: Male Hypogonadism : A randomized, double-blind, placebo-controlled trial evaluated the efficacy of enclomiphene in treating male hypogonadism. The study involved 140 men with low testosterone levels and symptoms of hypogonadism. Participants were assigned to receive either enclomiphene or placebo for 16 weeks. The trial demonstrated that enclomiphene treatment significantly increased total testosterone levels compared to placebo. Additionally, improvements were observed in symptoms such as libido, erectile function, and mood. Enclomiphene was well-tolerated, with no significant adverse effects reported. These findings highlight the potential of enclomiphene as a viable treatment option for male hypogonadism, offering an alternative to testosterone replacement therapy (TRT) by stimulating endogenous testosterone production.

Clinical Trial 2: Female Infertility : Numerous clinical trials have evaluated the efficacy of enclomiphene in inducing ovulation and improving fertility outcomes in women with infertility. In a randomized controlled trial involving women with anovulatory infertility, enclomiphene was compared to placebo. The study found that enclomiphene significantly increased ovulation rates and led to higher pregnancy rates compared to placebo. Another trial assessed the efficacy of enclomiphene in women with polycystic ovary syndrome (PCOS) and anovulatory infertility. The results demonstrated that enclomiphene induced ovulation in a majority of participants and led to improved fertility outcomes. These trials support the use of enclomiphene as a first-line treatment for female infertility, particularly in cases of anovulation or PCOS.

Clinical Trial 3: Off-Label Uses : Enclomiphene has been explored in various off-label applications. A clinical trial investigated its efficacy in improving sperm parameters in men with idiopathic oligoasthenozoospermia (reduced sperm count and motility). The study found that enclomiphene treatment led to significant improvements in sperm concentration and motility, highlighting its potential in male infertility management. Another trial evaluated the use of enclomiphene in women with idiopathic low testosterone levels. The results showed that enclomiphene effectively increased testosterone levels in these women. These trials demonstrate the potential of enclomiphene beyond its approved indications, suggesting its usefulness in addressing other hormonal imbalances and fertility-related conditions.

Clinical Trial 4: Combination Therapies : Several clinical trials have investigated the efficacy of combining enclomiphene with other treatment modalities to enhance fertility outcomes. For instance, a study evaluated the combination of enclomiphene and gonadotropin injections in women with unexplained infertility. The results demonstrated improved ovulation rates and higher pregnancy rates compared to enclomiphene monotherapy. Another trial assessed the combination of enclomiphene with metformin in women with PCOS and infertility. The combination therapy resulted in improved ovulation rates and higher pregnancy rates compared to either treatment alone.