It could be the best thing to happen to men’s sex lives since the Pill — and most people have never even heard of it.
A potentially revolutionary method of male birth control — a single injection that’s 100 percent effective in preventing pregnancy for a decade, and is accompanied by nary a side effect — is already in clinical trials in India and could be available here in just a few years.
A single advocate won’t give up until RISUG, the clunky acronym for “reversible inhibition of sperm under guidance,” is a Food and Drug Administration-approved option for couples looking to knock boots without getting knocked up.
Elaine Lissner’s interest in male contraceptives was piqued in the late 1980s when, as an undergraduate at Stanford, she was told during an academic lecture that she and her female peers “would never see a male contraceptive akin to the birth control pill in our lifetime.”
At the same time, Lissner was seeing female friends struggle with the uncomfortable side effects of contraceptives, and had her own pregnancy scare at 19.
“I realized there must be a better answer, but it wasn’t being pursued,” Lissner, who lives in San Francisco, told The Daily. “Ideally, I want to see a contraceptive supermarket for men the way there is for women.”
She founded an advocacy group, the Male Contraception Information Project, to make information about various methods and their research status accessible. By 2001, Lissner had become convinced that RISUG was the most promising male contraceptive in development, and she started to work closely with the Indian research team, led by professor Sujoy Guha at the Indian Institute of Technology, which has been doing clinical trials with RISUG for more than 20 years.
“The first men to try RISUG there have had it for decades, without problems,” Lissner said, adding that RISUG is now in stage III clinical trials with 500 participants planned, and could be approved for general use within a few years. “We know it works. But we need to prove it here.”
Most other methods of male contraception being developed or studied rely on hormones, usually testosterone and progestin, to prevent the production of sperm. Unfortunately, preliminary results have been disappointing: A mysterious 5 to 20 percent of men don’t respond to the products, which often need to be administered via an inconvenient intramuscular injection rather than a simple tablet or cream.
Not to mention the side effects: A 2010 WHO-sponsored clinical trial of one hormonal method, called TU/NET-EN, was called off early because participants suffered depression, weight gain and increased aggression.
“The adverse effects were too significant, and they weren’t expected,” Dr. Doug Colvard, director of programs at CONRAD, a nonprofit contraceptive research outfit that led the development of TU/NET-EN, told The Daily. “It’s important to remember these aren’t benign drugs. You give people hormones, there will be an effect.”
Although several other male contraceptives — including an ultrasound system and drugs that stall sperm maturation — are still being developed, researchers and advocates warn that without a major pharmaceutical company involved, progress will continue to lag.
“Pharma companies have left the arena; they don’t see a return on investment,” Dr. John Townsend, director of the Population Council’s reproductive health program, told The Daily. “Trust me: Putting their millions into medication for aging baby boomers makes a lot more sense than putting it into contraceptive options.”
Debate persists about how big a market exists for male contraceptives. In an international 2005 poll, about 50 percent of American respondents and 63 percent of European respondents expressed “willingness to try” a new option.
“These are new generations of men, and I think they’ll be increasingly interested,” Townsend said. “Women will want their partners to be involved in reproductive responsibility.”
Lissner agrees, and she’s betting on men’s interest — and RISUG’s potential. In 2005, she founded a nonprofit, the Parsemus Foundation, to invest in the method. Last year, the foundation purchased the international rights to RISUG and started manufacturing the compound — renamed Vasalgel — in the United States.
In India, RISUG boasts a 100 percent success rate: No pregnancies have been reported in the decades since the compound was first tested in humans. And the injection — which partially blocks the vas deferens to prevent sperm passage and also breaks the cell membranes of sperm, rendering them infertile — hasn’t registered a single major side effect.
Some American experts, though, are concerned that RISUG might not be reversible: Guha has informally reversed the injection in a handful of men and hundreds of animals, but has only published formal studies on the animal reversals.
“Certainly it’s a promising project, but there’s a lot we don’t know,” Colvard said. “Without safe reversal, men are just as well off getting a vasectomy.”
That’s exactly where Lissner plans to start: Animal trials are expected to start this year, and the first clinical trial of Vasalgel will kick off in 2012, with male participants open to permanent infertility on the off chance that the injection can’t be reversed.
And, in a move that could keep RISUG research alive where other male contraceptive projects have died, Lissner will circumvent pharmaceutical companies entirely. Using funds raised by Parsemus, and creating a social venture whereby investors can see a return on their money, she’ll finance the studies — expected to run upwards of $5 million — that would help bring RISUG to market.
Lissner hopes to see the product approved in the United States by 2015.
Katie.Drummond@thedaily.com
A potentially revolutionary method of male birth control — a single injection that’s 100 percent effective in preventing pregnancy for a decade, and is accompanied by nary a side effect — is already in clinical trials in India and could be available here in just a few years.
A single advocate won’t give up until RISUG, the clunky acronym for “reversible inhibition of sperm under guidance,” is a Food and Drug Administration-approved option for couples looking to knock boots without getting knocked up.
Elaine Lissner’s interest in male contraceptives was piqued in the late 1980s when, as an undergraduate at Stanford, she was told during an academic lecture that she and her female peers “would never see a male contraceptive akin to the birth control pill in our lifetime.”
At the same time, Lissner was seeing female friends struggle with the uncomfortable side effects of contraceptives, and had her own pregnancy scare at 19.
“I realized there must be a better answer, but it wasn’t being pursued,” Lissner, who lives in San Francisco, told The Daily. “Ideally, I want to see a contraceptive supermarket for men the way there is for women.”
She founded an advocacy group, the Male Contraception Information Project, to make information about various methods and their research status accessible. By 2001, Lissner had become convinced that RISUG was the most promising male contraceptive in development, and she started to work closely with the Indian research team, led by professor Sujoy Guha at the Indian Institute of Technology, which has been doing clinical trials with RISUG for more than 20 years.
“The first men to try RISUG there have had it for decades, without problems,” Lissner said, adding that RISUG is now in stage III clinical trials with 500 participants planned, and could be approved for general use within a few years. “We know it works. But we need to prove it here.”
Most other methods of male contraception being developed or studied rely on hormones, usually testosterone and progestin, to prevent the production of sperm. Unfortunately, preliminary results have been disappointing: A mysterious 5 to 20 percent of men don’t respond to the products, which often need to be administered via an inconvenient intramuscular injection rather than a simple tablet or cream.
Not to mention the side effects: A 2010 WHO-sponsored clinical trial of one hormonal method, called TU/NET-EN, was called off early because participants suffered depression, weight gain and increased aggression.
“The adverse effects were too significant, and they weren’t expected,” Dr. Doug Colvard, director of programs at CONRAD, a nonprofit contraceptive research outfit that led the development of TU/NET-EN, told The Daily. “It’s important to remember these aren’t benign drugs. You give people hormones, there will be an effect.”
Although several other male contraceptives — including an ultrasound system and drugs that stall sperm maturation — are still being developed, researchers and advocates warn that without a major pharmaceutical company involved, progress will continue to lag.
“Pharma companies have left the arena; they don’t see a return on investment,” Dr. John Townsend, director of the Population Council’s reproductive health program, told The Daily. “Trust me: Putting their millions into medication for aging baby boomers makes a lot more sense than putting it into contraceptive options.”
Debate persists about how big a market exists for male contraceptives. In an international 2005 poll, about 50 percent of American respondents and 63 percent of European respondents expressed “willingness to try” a new option.
“These are new generations of men, and I think they’ll be increasingly interested,” Townsend said. “Women will want their partners to be involved in reproductive responsibility.”
Lissner agrees, and she’s betting on men’s interest — and RISUG’s potential. In 2005, she founded a nonprofit, the Parsemus Foundation, to invest in the method. Last year, the foundation purchased the international rights to RISUG and started manufacturing the compound — renamed Vasalgel — in the United States.
In India, RISUG boasts a 100 percent success rate: No pregnancies have been reported in the decades since the compound was first tested in humans. And the injection — which partially blocks the vas deferens to prevent sperm passage and also breaks the cell membranes of sperm, rendering them infertile — hasn’t registered a single major side effect.
Some American experts, though, are concerned that RISUG might not be reversible: Guha has informally reversed the injection in a handful of men and hundreds of animals, but has only published formal studies on the animal reversals.
“Certainly it’s a promising project, but there’s a lot we don’t know,” Colvard said. “Without safe reversal, men are just as well off getting a vasectomy.”
That’s exactly where Lissner plans to start: Animal trials are expected to start this year, and the first clinical trial of Vasalgel will kick off in 2012, with male participants open to permanent infertility on the off chance that the injection can’t be reversed.
And, in a move that could keep RISUG research alive where other male contraceptive projects have died, Lissner will circumvent pharmaceutical companies entirely. Using funds raised by Parsemus, and creating a social venture whereby investors can see a return on their money, she’ll finance the studies — expected to run upwards of $5 million — that would help bring RISUG to market.
Lissner hopes to see the product approved in the United States by 2015.
Katie.Drummond@thedaily.com
