madman
Super Moderator
Transdermal gel application pump. The gel is filled into 90 mL metered dose pumps designed to dispense 2.5 mL/actuation. Two of these bottles allow monthly treatment of 5 mL/d. The daily dose delivers 8 mg of Nestorone (NES) and 74 mg of testosterone (T), of which 10% are absorbed; 0.8 mg of NES and 7.4 mg of T per day.
* A transdermal gel delivering Nestorone (segesterone acetate) and testosterone is under development and is leading the way in advancing novel, self-delivered methods of male hormonal contraception.
* The transdermal gel delivering NES and T is the most advanced product in the male contraceptive pipeline. Early data from users of the gel in clinical trials show high acceptability. If its efficacy and safety are confirmed, NES/T gel will bring to men a novel, user-controlled method of contraception, which could be a game changer in couples’ decisions regarding their fertility regulation.
Fig. 1. Structures of steroidal compounds (natural and synthetic) used in a transdermal gel currently in development.
Fig. 2. Transdermal gel application pump. The gel is filled into 90 mL metered dose pumps designed to dispense 2.5 mL/actuation. Two of these bottles allow monthly treatment of 5 mL/d. The daily dose delivers 8 mg of Nestorone (NES) and 74 mg of testosterone (T), of which 10% are absorbed; 0.8 mg of NES and 7.4 mg of T per day.
Abstract
While there are several easy-to-use reversible female contraceptives, little is available for men. Introduction of novel, cost-effective male contraceptives could have important downstream global health and economic benefits. Currently, nearly half of all pregnancies globally are unintended, with many resulting in unsafe abortions, a significant burden for women and families in many countries.
Available reversible options for male contraception include male condoms or withdrawal, both with high typical use failure rates, and vasectomy, which is not easily reversible. Advanced methods of male hormonal contraception include combinations of progestin and androgen, generally testosterone itself. Administration of these steroids results in the suppression of gonadotropins leading to the suppression of sperm production with full reversibility within a few months. Importantly, the exogenous androgen replaces the suppressed endogenous testosterone, minimizing side effects for the user. Using the skin to deliver steroids in the systemic circulation is a well-accepted concept both for the treatment of hypogonadism and contraception. A transdermal gel delivering Nestorone (segesterone acetate) and testosterone is under development and is leading the way in advancing novel, self-delivered methods of male hormonal contraception.
6. Conclusions
Consensus recommendations from the research community suggest metrics for evaluating novel male hormonal contraceptives and establishing effectiveness and safety levels, but whether these will be adopted by regulators is unknown [15], [44]. Greater advocacy is needed to push the field forward and convince funders and the pharmaceutical industry that there is a demand for this technology [46]. The development of male contraceptives will not replace female contraceptives, and an array of choices is needed. Access to contraception and safe reproductive health care are a fundamental human right for all people and a necessary component of public health. However, many men wish to share the burden of contraception with their partners; others want their own reproductive autonomy. Men are ready, but their contraceptive options are sparse. The transdermal gel delivering NES and T is the most advanced product in the male contraceptive pipeline. Early data from users of the gel in clinical trials show high acceptability. If its efficacy and safety are confirmed, NES/T gel will bring to men a novel, user-controlled method of contraception, which could be a game changer in couples’ decisions regarding their fertility regulation.
Most research for male contraception has been funded through the public sector. Research must continue to develop effective, reversible options for men to allow shared responsibility in the couple’s fertility regulation as many men wish to take a more active role in family planning. Given the high demand documented in recent large surveys, it is time to encourage industry partners to engage in this field and speed up the development of new contraceptive choices for men.
* A transdermal gel delivering Nestorone (segesterone acetate) and testosterone is under development and is leading the way in advancing novel, self-delivered methods of male hormonal contraception.
* The transdermal gel delivering NES and T is the most advanced product in the male contraceptive pipeline. Early data from users of the gel in clinical trials show high acceptability. If its efficacy and safety are confirmed, NES/T gel will bring to men a novel, user-controlled method of contraception, which could be a game changer in couples’ decisions regarding their fertility regulation.
Fig. 1. Structures of steroidal compounds (natural and synthetic) used in a transdermal gel currently in development.
Fig. 2. Transdermal gel application pump. The gel is filled into 90 mL metered dose pumps designed to dispense 2.5 mL/actuation. Two of these bottles allow monthly treatment of 5 mL/d. The daily dose delivers 8 mg of Nestorone (NES) and 74 mg of testosterone (T), of which 10% are absorbed; 0.8 mg of NES and 7.4 mg of T per day.
Abstract
While there are several easy-to-use reversible female contraceptives, little is available for men. Introduction of novel, cost-effective male contraceptives could have important downstream global health and economic benefits. Currently, nearly half of all pregnancies globally are unintended, with many resulting in unsafe abortions, a significant burden for women and families in many countries.
Available reversible options for male contraception include male condoms or withdrawal, both with high typical use failure rates, and vasectomy, which is not easily reversible. Advanced methods of male hormonal contraception include combinations of progestin and androgen, generally testosterone itself. Administration of these steroids results in the suppression of gonadotropins leading to the suppression of sperm production with full reversibility within a few months. Importantly, the exogenous androgen replaces the suppressed endogenous testosterone, minimizing side effects for the user. Using the skin to deliver steroids in the systemic circulation is a well-accepted concept both for the treatment of hypogonadism and contraception. A transdermal gel delivering Nestorone (segesterone acetate) and testosterone is under development and is leading the way in advancing novel, self-delivered methods of male hormonal contraception.
6. Conclusions
Consensus recommendations from the research community suggest metrics for evaluating novel male hormonal contraceptives and establishing effectiveness and safety levels, but whether these will be adopted by regulators is unknown [15], [44]. Greater advocacy is needed to push the field forward and convince funders and the pharmaceutical industry that there is a demand for this technology [46]. The development of male contraceptives will not replace female contraceptives, and an array of choices is needed. Access to contraception and safe reproductive health care are a fundamental human right for all people and a necessary component of public health. However, many men wish to share the burden of contraception with their partners; others want their own reproductive autonomy. Men are ready, but their contraceptive options are sparse. The transdermal gel delivering NES and T is the most advanced product in the male contraceptive pipeline. Early data from users of the gel in clinical trials show high acceptability. If its efficacy and safety are confirmed, NES/T gel will bring to men a novel, user-controlled method of contraception, which could be a game changer in couples’ decisions regarding their fertility regulation.
Most research for male contraception has been funded through the public sector. Research must continue to develop effective, reversible options for men to allow shared responsibility in the couple’s fertility regulation as many men wish to take a more active role in family planning. Given the high demand documented in recent large surveys, it is time to encourage industry partners to engage in this field and speed up the development of new contraceptive choices for men.
