Testosterone May Benefit Postmenopausal Women Without Ovaries, Uterus
Postmenopausal women who have undergone surgical removal of their uterus with or without ovaries may benefit from testosterone administration, according to data published in Menopause.
“Recently, there has been a lot of interest in testosterone treatment in postmenopausal women for sexual dysfunction and other various health conditions. However, no previous studies have evaluated the benefits and negative effects of testosterone replacement over a wide range of doses,” Grace Huang, MD, of Brigham and Women’s Hospital, said in a press release.
The Testosterone Dose Response in Surgically Menopausal Women (TDSM) was a multicenter, parallel-group, placebo-controlled, double blind, randomized trial that included the administration of transdermal estradiol for a 12-week run-in period, followed by a 16-week recovery period.
Researchers included 62 postmenopausal women who previously underwent hysterectomy with or without oophorectomy and had total testosterone levels <31 ng/dL or free testosterone levels <3.5 pg/mL in the final analysis.
They were administered a standardized transdermal estradiol therapy during the 12-week run-in period and were randomly assigned to either weekly intramuscular injections of placebo (n=15) or one of four testosterone enanthate doses given weekly for 24 weeks: 3 mg (n=14), 6.25 mg (n=14), 12.5 mg (n=15) or 25 mg (n=13).
The mean on-treatment total testosterone concentrations were 19 ng/dL in the placebo group, 78 ng/dL in the 3-mg group, 102 ng/dL in the 6.25-mg group, 128 ng/dL in the 12.5-mg group and 210 ng/dL in the 25-mg group, according to data.
According to data collected from the Brief Index of Sexual Functioning for Women scores, changes in composite thoughts/desire, arousal, frequency of sexual activity, lean body mass, chest-press power and loaded stair-climb power were significantly related to increased free testosterone concentrations (P<.05), researchers wrote.
These changes were significantly greater among women assigned to the 25-mg group but not among patients in the lower-dosed groups vs. placebo (P<.05). In addition, sexual activity increased by 2.7 encounters per week in the 25-mg group compared with the placebo group (P<.01), researchers wrote.
“A primary concern with testosterone therapy is that it can cause symptoms of masculinization among women. These symptoms include unwanted hair growth, acne, and lower voice tone. It’s important to note that very few of these side effects were seen in our study,” Huang said.
As this is currently an off-label use of testosterone, long-term trials are needed to better understand improvements in these outcomes compared with potential long-term adverse events, researchers wrote.
Disclosure: One researcher reports financial ties with Eli Lilly and Company, Merck and Regeneron Pharmaceuticals.
Source: http://www.healio.com/endocrinology/hormone-therapy/news/online/%7Ba745bdfd-1778-4a6d-97f9-7fb166fa4072%7D/testosterone-may-benefit-postmenopausal-women-without-ovaries-uterus
“Recently, there has been a lot of interest in testosterone treatment in postmenopausal women for sexual dysfunction and other various health conditions. However, no previous studies have evaluated the benefits and negative effects of testosterone replacement over a wide range of doses,” Grace Huang, MD, of Brigham and Women’s Hospital, said in a press release.
The Testosterone Dose Response in Surgically Menopausal Women (TDSM) was a multicenter, parallel-group, placebo-controlled, double blind, randomized trial that included the administration of transdermal estradiol for a 12-week run-in period, followed by a 16-week recovery period.
Researchers included 62 postmenopausal women who previously underwent hysterectomy with or without oophorectomy and had total testosterone levels <31 ng/dL or free testosterone levels <3.5 pg/mL in the final analysis.
They were administered a standardized transdermal estradiol therapy during the 12-week run-in period and were randomly assigned to either weekly intramuscular injections of placebo (n=15) or one of four testosterone enanthate doses given weekly for 24 weeks: 3 mg (n=14), 6.25 mg (n=14), 12.5 mg (n=15) or 25 mg (n=13).
The mean on-treatment total testosterone concentrations were 19 ng/dL in the placebo group, 78 ng/dL in the 3-mg group, 102 ng/dL in the 6.25-mg group, 128 ng/dL in the 12.5-mg group and 210 ng/dL in the 25-mg group, according to data.
According to data collected from the Brief Index of Sexual Functioning for Women scores, changes in composite thoughts/desire, arousal, frequency of sexual activity, lean body mass, chest-press power and loaded stair-climb power were significantly related to increased free testosterone concentrations (P<.05), researchers wrote.
These changes were significantly greater among women assigned to the 25-mg group but not among patients in the lower-dosed groups vs. placebo (P<.05). In addition, sexual activity increased by 2.7 encounters per week in the 25-mg group compared with the placebo group (P<.01), researchers wrote.
“A primary concern with testosterone therapy is that it can cause symptoms of masculinization among women. These symptoms include unwanted hair growth, acne, and lower voice tone. It’s important to note that very few of these side effects were seen in our study,” Huang said.
As this is currently an off-label use of testosterone, long-term trials are needed to better understand improvements in these outcomes compared with potential long-term adverse events, researchers wrote.
Disclosure: One researcher reports financial ties with Eli Lilly and Company, Merck and Regeneron Pharmaceuticals.
Source: http://www.healio.com/endocrinology/hormone-therapy/news/online/%7Ba745bdfd-1778-4a6d-97f9-7fb166fa4072%7D/testosterone-may-benefit-postmenopausal-women-without-ovaries-uterus
Comments
Post a Comment