This trial is evaluating whether Testosterone cypionate will improve 2 primary outcomes, 11 secondary outcomes, and 15 other outcomes in patients with Hypogonadism. Measurement will happen over the course of Baseline and 6 months.
This trial requires 150 total participants across 2 different treatment groups
This trial involves 2 different treatments. Testosterone Cypionate is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.
These 3 trials are important because all of them found testosterone to be as effective as or even more effective than oral testosterone when given in combination with a GnRH stimulation dose. It remains to be determined whether or not there are other [drug treatment trials for testosterone to be able to prove its effectiveness.
The most common treatments for hypogonadism are hormonal contraceptives and/or estrogen-containing oral contraceptive pills that are taken on a regular basis or, in some cases, continuously for a prolonged period of time. In contrast, testosterone or nonhormonal treatments are typically used only temporarily as short-term remedies. This latter group is the most common treatment for hypogonadism across all age groups.
There is low response to estrogen therapy for patients with congenital hypogonadism. Long-term treatment in adulthood is still needed to achieve and maintain optimal hormonal production.
As the ageing epidemic accelerates, men will increasingly have difficulty in achieving optimal physical performance. Reduced circulating testosterone might be one of the contributing factors to this performance decline in middle age. A higher prevalence of hypogonadism was reported among middle-aged and older males living in less affluent countries than well-nourished counterparts.
Normal gonadal function and libido are necessary for a man's sexual functioning. Failure of these two functions leads to hypogonadism. In other words, the lack of proper androgen action causes the lack of libido and the lack of sexual functioning.
Hormonal dysfunction should be suspected in hypoestrogenism when a female patient has hypoestrogenic symptoms in response to low or high dosages of the gonadal hormone replacement therapy. Furthermore, the signs of hypoestrogenism are usually mild and may go unnoticed, particularly at very low dosages of estrogen replacement. However, when hypoestrogenism is seen in the female subjects without other symptoms suggestive of hypoestrogenism, it is not always due to malfunction of the hypothalamic/pituitary gonadal axis.
Approximately 14.5 million US men and women received an IUD from 1992 to 1999. There were 37,040,702 pregnancies among US live births in 1999, which resulted in 12,982 children with a congenital anomaly. Approximately 2,880 will be diagnosed with hypogonadism and 1,650 with delayed puberty.
Testosterone cypionate should be avoided by women using oral contraceptives due to the increase in body triglycerides. The risk of insulin-resistant diabetes with testosteonecypionate is less than that with testosterone. However, further studies are needed to confirm the effectiveness and side effects of testosterone cypionate.
Testosterone cypionate has no direct or indirect antimineralocorticoid effects in man in doses up to a maximum of 1000 mg/kg sc a week . The testosterone levels, though suppressed, remain within the normal physiologic range and, therefore, do not cause hypergonadotropic hypogonadism. On the other hand, in addition to an increase in endogenous testosterone levels, testosterone is metabolized by its cypionate conjugate (i.e., testosterone cypionate) to the active testosterone form.
These data suggest that the familial pattern of ED is not primarily a consequence of familial inheritance of a predisposing gene, but rather represents a disorder of sex development and is the result of environmental influences affecting both sexes at differing ages.
Most of the participants had testosterone cypionate injected only once or twice during the 12-week treatment period and no additional treatment during the follow-up period. The use of other hormonal and nonhormonal treatments were relatively small. This is a reasonable argument against the use of testosterone cypionate in combination with other treatments. We found limited information on a number of the individual treatment options for which combination treatments were used. We did not feel that more information for any of these options would alter our conclusion.
The most severe forms of hypogonadism are rare and usually observed in those who suffer from severe infection; however, low testosterone levels are also considered a symptom of Cushing's syndrome which can lead to Cushingoid appearance and is considered a medical emergency. Milder forms of hypogonadism occur commonly in adolescence, especially males. These include low T levels in some obese males who have never experienced low T levels. Low levels can also be a presentation in some forms of sexual abuse during childhood. Therefore, patients should be familiar with this symptom in clinical presentations. Patients need to avoid drugs that can lower T levels, for example the antiandrogen bicalutamide.