Encouraging results from clinical trials of two male birth control pills

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At ENDO 2022, the endocrine society At the annual meeting in Atlanta, researchers are presenting positive results from a study examining the acceptability and willingness to take two male oral contraceptive pills that are in clinical trials.

The Burden of Birth Control

Contraception is used to prevent pregnancy that occurs intentionally as a result of sexual intercourse. While many approaches are contemporary in nature, humans have attempted to manipulate and control fertility for thousands of years. That earliest recordings of the use of birth control originated in Mesopotamia, ca. 1850 BC.

Today, only women Contraceptive methods are prevalent worldwide, including hormonal and non-hormonal approaches such as the pill, intrauterine devices (IUDs), injections and implants. Vasectomy and using a condom are the only options available to men.

The burden placed on women when using contraception goes beyond the physical, explains Katrina Kimport, who has published an extensive article outline the emotional and mental toll of preventing pregnancy. So why is there this discrepancy between male and female options? “I think male birth control options are limited today for a variety of reasons,” she explains Tamara Jacobsohn, Research Fellow in the Contraceptive Development Program at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. “These include Challenges in developing a novel drug that can be used by healthy men who do not face health risks from pregnancy. The bar for security is very high; So we need extensive testing to make sure there are no health risks (which is different from side effects),” says Jacobsohn. Further complications arise from the fact that oral formulations of testosterone derivatives require multiple daily doses.

The final reason Jacobsohn highlights as a barrier to male contraceptive use is stigma. “Currently, there are widespread negative narratives about men being unwilling to use male contraceptives. However, the results of our clinical trials of male contraceptive candidates show otherwise. With greater awareness of the potential market for these products, big pharma might be more interested in supporting research. If that happens, it could help speed up the process of developing more options for men,” she says.

Male contraceptives in clinical trials

A growing number of male contraceptive drugs are entering the preclinical and clinical pipeline for testing. Two key examples are DMAU and 11β-MNTDC.

DMAU and 11β-MNTDC are progestogenic androgens, meaning they are single agents with dual functions. The progestin function serves to decrease the pituitary production of gonadotropin hormones (FSH and LH). Inhibition of LH leads to lower levels of testosterone in the testicles. In theory, in the absence of sufficient testosterone in the testes, sperm production would be inhibited. The androgenic function of these molecules supports sexual function and other bodily functions that depend on adequate testosterone levels in the blood,” describes Jacobsohn.

These progestogenic androgens are being researched for their oral bioavailability, meaning they can be used as a tablet, and the fact that they can be administered as a single drug, eliminating the need for multiple dosing. “The oral studies are currently in phase 1b testing (repeated dosing); Therefore, we look at the pharmacodynamics, pharmacokinetics and safety of the drug,” says Jacobsohn.

Testosterone is a hormone central to male physiological functions such as sexual function and the maintenance of muscle mass. Lowering testosterone levels can be associated with undesirable side effects, explains Jacobsohn: “Testosterone is converted to estradiol in men, which supports bone health and other estrogen-dependent functions. Side effects of low testosterone or estradiol levels can include mood swings, hot flashes, loss of libido, erectile dysfunction, acne, or weight gain.”

These potential side effects have inhibited the development of male contraceptives that work through this modality. at At ENDO 2022, the annual meeting of the Endocrine Society in Atlanta, Georgia, Jacobsohn will present her latest research examining how men participating in clinical trials of DMAU and 11β-MNTDC respond to lower testosterone levels, their satisfaction with the drug, and their willingness to use it in the future, or to recommend it to others.

Significantly higher willingness to take the male birth control pill

The study cohort included 96 healthy male participants recruited into Phase 1 clinical trials of the two drugs. In both studies, participants were randomized to receive either two (total drug concentration 200 mg) or four (total drug concentration 400 mg) oral pills of the active ingredient or placebo daily for 28 days. In the drug-treated groups, testosterone levels fell below the normal range after seven days, while those in the placebo group were found to remain within the normal range.

“To examine acceptance, we provided a questionnaire to be answered at the end of the study. Relevant questions included, “Were you satisfied with the study medication?”, “Would you recommend the study pill to other men?”, and “Would you use this pill as your primary form of birth control?” says Jacobsohn.

We found that those taking the 200 mg and 400 mg pills had significantly lower testosterone levels in the suppression phase (days 7 to 28 of treatment) compared to the placebo group. We also found that those taking the 400 mg drug had significantly lower testosterone levels compared to the 200 mg group, for each drug separately and with the combination of each drug,” she adds.

The researchers’ data are encouraging. They found that men found the pill very acceptable – the combination drug group showed a significantly higher willingness to use this drug as the primary method of contraception compared to placebo. “The significantly lower testosterone levels in those receiving the higher dose did not appear to result in significantly different acceptability for any of the questions asked,” describes Jacobhson.

The research team notes that the nature of the study’s recruitment, ie men interested in participating in a male contraceptive clinical trial, somewhat limits the study results. “We cannot make generalizations about men as a whole. Because novel male contraceptives are still being tested in clinical trials, our report on men’s willingness to use novel male contraceptives may overstate actual usage rates when a male contraceptive becomes available,” says Jacobsohn.

DMAU and 11β-MNTDC are progressing into a phase II study. In addition, they are also being studied in phase 1a trials using injection as the delivery method. In addition to these two drugs, Jacobsohn points out that there are other products in the clinical trial pipeline: “We are currently completing a Phase IIb trial (efficacy) for a Nestorone/Testosterone combined gel product that we are hoping for that it will be the first breakthrough product for male contraception, paving the way for other drugs to become available,” she concludes.

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