Male contraceptive study expands to 4 US cities
Because of strong initial interest, a new male contraceptive will now be available at three additional study sites. "We haven't even opened our doors yet, and men are already contacting us," said Janelle Antil, clinical trials coordinator for Shepherd Medical Company. "We figured it was a pretty good sign, so we decided to take a chance on expanding."
The manufacturer is designing a new male contraceptive dubbed the IVD (Intra Vas Device). The original St. Paul, Minnesota site will begin accepting patients on Monday October 16, and enrollment will begin by the end of October at new sites in St. Cloud, Minnesota; Shreveport, Louisiana; and Tampa, Florida.
The IVD is a long-term contraceptive designed as an alternative to vasectomy. The new device aims to block sperm by plugging the tube they travel through (called the vas deferens) on the way to joining with the rest of the semen. In a vasectomy, that tube is simply cut. Neither solution interferes with libido or masculinity, but researchers hope men will find the plug idea more appealing.
"Somehow psychologically, it's a little easier to think about something being added than something being cut," said Elaine Lissner, director of the nonprofit Male Contraception Information Project based in San Francisco. "They put in two tiny, soft silicone plugs per side, and any sperm that make it past the first plug are stopped by the second. It's not rocket science, but it seems to do the job."
The current study is the second one to research IVD use in men. In the pilot study, the new contraceptive was very effective: All 30 men either had no sperm in their semen or had levels too low to cause a pregnancy.
Reversibility still unknown
Lissner stressed that right now the method is only for men who are finished having children. Early studies in monkeys showed reversibility after seven months of use, but reversibility studies in men have only tested same-day insertion and removal.
"It's a lot easier to pull the plugs out than to find the best, most expensive micro-surgeon to sew a vas deferens back together. So that's a plus for the IVD," said Lissner. "But we know that in a vasectomy, even if you can get sperm flowing again, the chances of a pregnancy go down about 10% for each year the man had the vasectomy. Only time will tell if it's the same for the IVD."
John, a 25-year-old in Rhode Island, doesn't mind the uncertainty about reversibility. "My fianceť and I agree that we don't want children. I've thought about vasectomy, but somehow I haven't been able to talk myself into it yet. This [IVD] seems a little more high-tech. If it turns out to be more reversible than vasectomy, so much the better. I only wish it were available closer to home."
John's strong desire to participate in contraception is far from unique. Condoms and vasectomy together account for one quarter to one third of contraceptive use in many countries. And each year about 500,000 American men get vasectomies, even though the procedure is only appropriate for men who are finished having children.
Condoms, though very effective when used perfectly, are often misused and are unpopular with long-term monogamous couples. Recent studies have consistently shown that a majority of men would welcome a third contraceptive option.
"Men are looking for the same thing as women -- something reliable but without side effects," says Dr. Neil Pollock, a Vancouver doctor who does about 1600 vasectomies a year and is head of Shepherd Medical's scientific advisory board. "The more choices men and women have, the more chances that there will be something right for everybody."
For IVD study enrollment and contact information, see ClinicalTrials.gov: http://www.clinicaltrials.gov/ct/show/NCT00335361?order=2
To read more about male contraception research, see www.MaleContraceptives.org.
Press resources and help for journalists writing about male contraceptive development are available from the nonprofit Male Contraception Information Project: www.NewMaleContraception.org .
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