Several male methods under development at the Council have relied on MENT®,
a synthetic steroid that resembles testosterone. In contrast to
testosterone, however, MENT does not have the effect of enlarging the
prostate, a drawback that occurs with testosterone administered for therapy.
A MENT implant and MENT transdermal gel and patch formulations are being
developed for contraception and hormone therapy.
MENT implants
Delivering MENT acetate (MENT Ac) via one or more implants placed under the
skin of the upper arm, this contraceptive aims to suppress sperm cell
development without impairing sexual drive (libido). Early developmental
work on the MENT Ac implant indicated that it might be appropriate both as a
contraceptive in normal men and as hormone therapy in men with male-hormone
deficiency (hypogonadal men). A recently completed one-year dose-finding
study in normal men has shown that four implants suppress gonadotropin
levels completely, leading to profoundly reduced sperm count. Eight of
eleven men with four implants had zero sperm count which lasted in many
subjects for several months until the implants were removed. In hypogonadal
men, two MENT Ac implants were found to be adequate as therapy, and the men
in the study preferred the implants to the standard therapy involving
multiple injections of a testosterone derivative.
Other studies that combine MENT Ac implants with a synthetic progestin
have been conducted. Long-term toxicology studies of MENT are also ongoing.
(more)
MENT transdermal gels and patches
Laboratory tests show that MENT readily penetrates the skin. The delivery of
a potent androgen through the skin into the blood stream is an effective way
to avoid metabolism by the liver, thereby decreasing side effects of the
hormone. Early studies in men indicated that MENT delivered via transdermal
gel suppressed steroid sex hormones over a seven-day treatment period, and
that the effect was reversible when the treatment ended. Preliminary studies
conducted in hypogonadal men also show the gel to be safe for further
development as a method of hormone therapy. (more)
Chile, Dominican Republic,
Germany, United Kingdom, United States
Ongoing
Narender Kumar, Frederick Schmidt,
Régine Sitruk-Ware, Irving Sivin
Richard Anderson, David T.
Baird (MRC Reproductive Biology Unit, Edinburgh)
Horacio Croxatto (ICMER, Chile)
Eberhard Nieschlag (University
of Munster, Germany)
Christina Wang (University of
California, Los Angeles)
The Lita Annenberg Hazen Foundation
The George J. Hecht Fund
The William and Flora Hewlett Foundation