Meeting the Challenges of Developing a Hormonal Birth Control Option for Men

Designed to Cure

As scientists try to find a safe and effective male birth control option, modern software may be able to improve the odds of success. Image Credit: Zappys Technology Solutions

Development of a viable male birth control option recently suffered a major setback when a proposed treatment was pulled from stage II clinical trials. The study had been going on for three years, and scientists were optimistic about the treatment, which was designed to suppress spermatogenesis. It consisted of an injection of testosterone and norethisterone enanthate, given every eight weeks, and it was almost 96% effective.1 However, as some of the 320 study participants started to experience side effects, including pain, increased sex drive, mood disorders and depression, two safety review panels voiced concerns, and the researchers decided to terminate the clinical trial.2

While the abandonment of the proposed treatment was certainly a disappointment for the research community, scientists have not yet given up hope on finding a safe and effective birth control option for men. As researchers explore the alternatives, modern software can be used to improve research efficiency so that a new treatment can be developed as quickly as possible.

Supporting the Early Research Process

Proposed approaches to the development of male birth control alternatives vary. Some scientists plan to continue to focus on finding ways to suppress spermatogenesis, testing different doses of the hormones used in the recent study, or combining them with other hormones. Other delivery methods might also be tested, such as a gel or implant instead of an intramuscular injection. At the same time, there are some researchers exploring different therapeutic targets; for instance, some groups are trying to develop therapies that interfere with sperm cell motility, rather than reducing the overall sperm count.

Unfortunately, much of this research is still in its early stages.3  With growing market interest in a safe and effective male birth control option, improving research efficiency in this area is essential so that a new therapy can reach consumers as soon as possible. It is also important to ensure the quality of potential therapies before they are brought to clinical trials in order to avoid another costly late-stage withdrawal.There are several ways that modern software can support improvements in the speed and quality of male birth control research:

  • Simplifying data analysis

 

Because of the massive amount of data generated by drug discovery efforts, it can be challenging to sort through results and identify ideal candidates for possible male birth control treatments. Data visualization tools can assist scientists by analyzing data from current and past experiments to uncover hidden trends and insights. Managing many of these processes in silico can also help reduce the potential for human error and improve the quality of the results. This helps scientists derive more value from more data more quickly. All of this combines to allow scientists to focus their efforts on innovation instead of the non-value-added tasks involved in laying the groundwork for these technical analyses.  

  • Integrating physical and computer-based experiments

 

In order to reduce the likelihood that a therapeutic candidate will be abandoned during clinical trials, extensive testing must be conducted in the early stages of research and development. While this can be a major time drain, the future losses resulting from early termination of a clinical trial would be even worse. By conducting some of the tests in silico instead of running only time-consuming physical tests, scientists can speed up the process as much as possible. Plus, a combination of computer-based and benchtop tests allows for a more comprehensive investigation of a therapeutic option before it enters clinical trials.

  • Facilitating research collaborations

 

Within research companies, different scientists and groups may be exploring different targets, compounds and delivery methods that could be used for male birth control. Because of the interrelated nature of the challenges being addressed for therapy development, it is important to be able to share findings that have the potential to shed light on the research of others. Modern software can  facilitate these collaborations, making it possible for scientists to work together to bring the most effective possible solutions to clinical trials. It also speeds up the R&D process by making it possible to immediately disseminate relevant information, even when colleagues are working in different locations.

Making Well-Informed Business Decisions

The success of a potential male birth control depends not only on its safety and effectiveness profile but also its appeal to potential users. For instance, one of the reasons that scientists held out so much hope for the injectable hormone treatment was that 75% of the men in the trial reported that they would be willing to use it in their daily lives, even after the study was canceled. Another important consideration is the cost of a potential treatment, as well as the logistical feasibility of widespread distribution. Because of the analytical and data-sharing capabilities of modern software, it is easier than ever for researchers and decision-makers within life sciences companies to work together to quickly identify the most promising therapeutics.

There’s no reason for scientists to give up on efforts to develop a male birth control option. It may be a few years out, but with modern technology, research groups can improve the quality and increase the speed of  research so that a safe and effective alternative can be made available as soon as possible.

BIOVIA Designed to Cure is a high-level software solution that can support researchers in the pharmaceutical industry throughout the R&D process. As failure rates increase and  lower quality drug candidates are entering clinical trials, it is essential for life sciences organizations to address the fundamental challenges underpinning lackluster results. Adopting a software solution like Designed to Cure can improve outcomes and help companies bring better therapeutics to market faster. Contact us today to learn more about this innovative software solution.

  1. “Efficacy and Safety of an Injectable Combination Hormonal Contraceptive for Men,” October 27, 2016, http://press.endocrine.org/doi/10.1210/jc.2016-2141
  2. “What does study backlash mean for future of male birth control?” November 2, 2016, http://www.cnn.com/2016/11/02/health/male-birth-control-shot/
  3. “Male Birth Control Study Killed After Men Report Side Effects,” November 3, 2016, http://www.npr.org/sections/health-shots/2016/11/03/500549503/male-birth-control-study-killed-after-men-complain-about-side-effects