A new combination of testosterone and nestorone transdermal gels for male hormonal contraception.
BACKGROUND
Combinations of testosterone (T) and nestorone (NES; a nonandrogenic progestin) transdermal gels may suppress spermatogenesis and prove appealing to men for contraception.


OBJECTIVE
The objective of the study was to determine the effectiveness of T gel alone or combined with NES gel in suppressing spermatogenesis.


METHODS
This was a randomized, double-blind, comparator clinical trial conducted at two academic medical centers.


METHODS
Ninety-nine healthy male volunteers participated in the study.


METHODS
Volunteers were randomized to one of three treatment groups applying daily transdermal gels (group 1: T gel 10 g+NES 0 mg/placebo gel; group 2: T gel 10 g+NES gel 8 mg; group 3: T gel 10 g+NES gel 12 mg).


METHODS
The main outcome variable of the study was the percentage of men whose sperm concentration was suppressed to 1 million/ml or less by 20-24 wk of treatment.


RESULTS
Efficacy data analyses were performed on 56 subjects who adhered to the protocol and completed at least 20 wk of treatment. The percentage of men whose sperm concentration was 1 million/ml or less was significantly higher for T+NES 8 mg (89%, P<0.0001) and T+NES 12 mg (88%, P=0.0002) compared with T+NES 0 mg group (23%). The median serum total and free T concentrations in all groups were maintained within the adult male range throughout the treatment period. Adverse effects were minimal in all groups.


CONCLUSIONS
A combination of daily NES+T gels suppressed sperm concentration to 1 million/ml or less in 88.5% of men, with minimal adverse effects, and may be further studied as a male transdermal hormonal contraceptive.
Department of Medicine, Harbor-University of California, Los Angeles, Medical Center and Los Angeles Biomedical Research Institute, 1000 West Carson Street, Torrance, California 90509, USA.
Niloufar
N
Ilani
Mara Y
MY
Roth
John K
JK
Amory
Ronald S
RS
Swerdloff
Clint
C
Dart
Stephanie T
ST
Page
William J
WJ
Bremner
Regine
R
Sitruk-Ware
Narender
N
Kumar
Diana L
DL
Blithe
Christina
C
Wang
D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000728:Androgens / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood; D003267:Contraception / Q000379:methods*; D003271:Contraceptive Agents, Female / Q000008:administration & dosage / Q000009:adverse effects; D004338:Drug Combinations; D005782:Gels / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D009653:Norprogesterones / Q000008:administration & dosage* / Q000009:adverse effects; D017060:Patient Satisfaction; D019529:Sexuality / Q000187:drug effects; D013091:Spermatogenesis / Q000187:drug effects*; D013739:Testosterone / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D055815:Young Adult
D000728:Androgens; D003271:Contraceptive Agents, Female; D004338:Drug Combinations; D005782:Gels; D009653:Norprogesterones; D013739:Testosterone; C029167:ST 1435