Updates on the progress of the IVD, RISUG and male hormonal contraception
Intra Vas Device (IVD)
Researchers are preparing to begin enrollment in their 90-man FDA-approved study of this long-term contraceptive. The IVD is currently being billed as a kinder, gentler vasectomy. Long-term reversibility is not yet known: restoring vas patency will certainly be much simpler and less costly than with traditional vasectomy, but it remains to be seen whether back-pressure and autoimmune reactions take a toll on fertility in the long run. Please pass this along to any patients or acquaintances in the Seattle or Minneapolis/St. Paul area who are considering a vasectomy and are interested in the newest alternative!
Read more about how the IVD works.
Read about the IVD trials in Seattle and Minneapolis.
For more information on patient enrollment in the trial, contact Janelle Antil, Clinical Affairs Manager for the Shepherd Medical Company.
RISUG
RISUG developers have approval to re-open their clinical study and enroll hundreds of additional men, but they have encountered a distressing delay: the pharmaceutical company they partnered with has not been able to manufacture RISUG in the promised time frame. The research team is now getting input from consultants in the U.S. and India on how to speed up RISUG production while ensuring that the end product meets international manufacturing standards.
Once the clinical study reopens, researchers will enroll only men living near the trial sites in India. If you and your patients would like to see RISUG available in your area sooner rather than later, please see the opportunity for members of the public to express their support below.
Male Hormonal Contraception
The evidence for men and women's acceptance of hormonal male contraceptives is growing. One recent study carried out at a research hospital in Italy showed that 3/4 of the men enrolled in a 12 month trial of an injectable male hormonal contraceptive rated the contraceptive acceptable, good or excellent. At a recent meeting of the European Society of Contraception (ESC), Dr. Richard Anderson of Edinburgh University summarized the findings of surveys of men around the world who expressed interest in a male hormonal contraceptive. He concluded: "These surveys give a clear and consistent message that both men and women want to see new male methods [of contraception] become available."
Dr. Regine Sitruk-Ware of the Population Council also spoke at the ESC meeting about a new androgen developed in-house. “7a-methyl-19-nortestosterone (MENT™) is a synthetic androgen that is more potent than T for gonadotropin suppression … MENT Acetate (MENT Ac) has diffusion characteristics that are well suited for delivery via subdermal implants, [and] is rapidly hydrolyzed in vivo to MENT, the biologically active molecule. MENT Ac implants administered once were able to suppress spermatogenesis to a degree comparable to those reported in studies with multiple injections of TE or testosterone undecanoate (TU) or with T implants in normal men.” MENT is unique among synthetic androgens because is does not overstimulate the prostate gland. This prostate sparing effect could create a long-term use health benefit. Research on MENT as a male contraceptive continues at the Population Council.
