For additional information about participating in this contraceptive gel trial, visit the study’s web page or call the study coordinator, Jasmin Alcantara, at 801-923-6705.
University of Utah Health scientists are testing a new contraceptive gel for men. Based on preliminary research conducted elsewhere, the scientists believe the hormonal gel decreases a man’s sperm production––reducing his chances of fathering a child––without decreasing his sex drive. The researchers say expanding contraceptive options for men could ease the burden on women who have traditionally borne a greater responsibility for birth control.
The researchers are recruiting 12 couples to participate in the two-year study, which is part of a nationwide, Phase 2 clinical trial supported by the National Institutes of Health.
"In our society, women have primarily been responsible for contraception because they, not necessarily men, have to live with the consequences," says David Turok, M.D., M.P.H, one of the trial’s principal investigators and chief of the Division of Family Planning in the Department of Obstetrics and Gynecology at U of U Health. "This is a fabulous opportunity for men to step up and take an active role in the development of new methods of contraception. By doing this, they can demonstrate to their partners that they’re invested in a better future for all of us.
Currently, heterosexual men who wish to minimize their and their partner’s risk of pregnancy have limited options. They can either use a condom, withdrawal, undergo a vasectomy, or abstain. The new gel, developed by the Population Council and the NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), could help expand their choices, Turok says.
The gel contains two hormones. The first is a synthetic progesterone called Nestorone®, which blocks natural testosterone production in the testes and reduces sperm production. The second, a replacement testosterone, helps maintain sex drive and other natural functions dependent on the hormone. The gel is applied to the men’s shoulders. Its effects are reversible.
In addition to assessing the effectiveness of the gel in preventing pregnancy, the researchers will also track how diligent men are at applying the gel daily as well as evaluating its acceptance as a contraceptive method.
To be eligible for the study, couples do not need to be U of U Health patients. However, they must be:
- Healthy and aged 18 to 50 (men) or 18 to 34 (women)
- Sexually active in a stable, mutually monogamous relationship for at least one year
- Have no infertility issues, and
- Women must have regular menstrual cycles between 21 and 35 days.
Once the study begins, men will be asked to apply the gel once a day. Because it can take four to six months for the contraceptive gel to fully take effect, couples will be required to use other forms of contraception during that time. After the man’s sperm count falls enough to prevent pregnancy, the couples will use the gel as their only form of birth control for 12 months. Throughout the study, researchers will monitor each man’s sperm count and testosterone levels.
After a year, the men will stop using the contraceptive gel and the study team will monitor their sperm count for at least four months or until it returns to a normal range.
Couples who participate in the full two-year study may receive up to $3,490 in compensation.
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In addition to Dr. Turok, U of U Health trial co-investigators include Jennifer Kaiser, MD, MA; Lori Gawron, MD, MPH; and Jessica Lewis-Caporal, DNP, APRN. They are assisted by Jasmin Alcantara, lead research coordinator; Amy Orr, clinical research coordinator; and Amy Alcantara, research assistant.
Other U.S. testing sites are in Sacramento and Torrance, California; Denver, Colorado; Kansas City, Kansas; Portland, Oregon; Philadelphia, Pennsylvania; Norfolk, Virginia; and Seattle, Washington. Testing is also occurring worldwide in Chile, Italy, Kenya, Sweden, and the United Kingdom.