KU Medical Center conducting clinical trial for male contraceptive gel
photo by: Sara Shepherd
A male contraceptive being tested at the University of Kansas Medical Center takes the form of a gel that men apply daily to their shoulders.
The research institution is currently conducting a clinical trial for the contraceptive, and is looking for couples to participate.
Dr. Ajay Nangia, the vice chair of urology at the medical center, is a collaborating investigator of the study.
“I think what we’re finding is in the big picture there’s a big need for a male contraceptive,” Nangia said.
The gel is a combination of Nestorone and testosterone. Nestorone blocks the production of male hormones needed to make sperm, and the testosterone in the gel replaces testosterone normally produced in the male body.
The gel should not reduce a man’s sex drive, and Nangia said a man’s sperm count should return to normal about three to nine months after discontinuing use of the gel. But that’s not ensured. The gel has only been used in short-term studies thus far. Those studies have shown a decline and then a return of sperm count, Nangia said. This phase two study is longer, however: participants will be on the drug for at least a year.
The gel is being developed by a nonprofit called The Population Council, in collaboration with the National Institute of Health. The primary investigators of the clinical trial are at the University of California in Los Angeles and the University of Washington, Nangia said. KU is a subsite of the study, one of many across the globe.
Nangia said on Friday that the KU Medical Center currently has three people on the drug. Since the center began actively promoting the study on Jan. 13, Nangia said, it had received 148 calls by Friday.
But while interest is high, it’s hard to find qualifying participants, Nangia said. There’s a limited number of people who end up on the drug.
“That’s why this is such a multi-institutional study; it’s going to take a lot of people,” Nangia said.
The study takes about two years in all. Men must be between the ages of 18 and 50 and visit the clinic about 31 times. Their female partner must be between the ages of 18 and 34 and visit the clinic about 10 times. Because of the frequency of the clinic visits, the medical center is only recruiting participants who live within 50 miles of the center.
The couple must be sexually active and have been in a stable, monogamous relationship for at least a year. The couple must also be open to having children, in case the contraceptive does not work.
To monitor that the male puts the gel on every day, Nangia said, all participants must keep a daily journal, and the men frequently have to return the gel bottles, at which point the researchers weigh the bottles to ensure the correct portion has been used.
The male partner would receive close to $2,985 for participating and the female, $1,140. Nangia called this payment minimal, due to the “cost of time and travel” associated with the clinic visits.