Menopause And HRT
According to the Imvexxy prescribing information, women should generally be started at the 4mcg dosage strength with dosage adjustment guided by clinical response.
The 5 topics addressed by the 11-member expert panel include epidemiology, clinical presentation, therapeutic effects of antidepressants, effects of hormone therapy, and the effectiveness of other therapies (eg, psychotherapy, exercise, natural health products).
The Agency has become aware of some manufacturers marketing these devices for vaginal "rejuvenation" or vaginal cosmetic procedures.
Evenity is a bone-forming monoclonal antibody designed to inhibit the activity of sclerostin, which allows the drug to rapidly increase bone formation and reduce bone resorption simultaneously.
Women prescribed long- vs short-term opioids for chronic musculoskeletal pain may be at increased risk for menopause and abnormal menstruation.
The FDA approval was supported by findings from a Phase 3, randomized, double-blind, placebo-controlled study that evaluated Imvexxy (4mcg and 10mcg) vs placebo from baseline to week 12.
There was a significant correlation for anxiety levels with age, menopausal age, years since menopause, and depressive symptoms; multiple regression analysis predicted reduced BMD in the lumbar spine.
The MENQOL sexual function domain had a significant between-group difference favoring vaginal estradiol (−0.4 at 12 weeks); significant differences were not seen for the other domains.
Forty percent indicated that they were currently sexually active; sexual activity decreased with age. More than half (54%) of respondents agreed that sex is important to their overall quality of life, with men more likely to agree than women (70 versus 40%).
"Our results suggest that some food groups (oily fish, fresh legumes, refined pasta and rice) and specific nutrients are individually predictive of age at natural menopause," the authors write.
This association was most pronounced with heavy drinking (odds ratio, 1.79). It is plausible there is a reverse causation process, in which PMS-affected women use alcohol to mitigate the effect of the syndrome.
The longitudinal decline in dorsolateral prefrontal cortex volumes was less in the tE2 group compared with the placebo group. In the menopausal hormone therapy groups, the rates of global cognitive change did not differ from that of the placebo group.
Similar reductions were seen for most bothersome symptom severity for all treatment groups over 12 weeks (estradiol, −1.4; moisturizer, −1.2; and placebo, −1.3).
At the 43-month endpoint, a total of 60.7% (307/506) of the abaloparatide followed by alendronate group had ≥3% increase in bone mass at all 3 sites (P<0.0001) vs. 24% (121/505) of the placebo followed by alendronate group.
The researchers found that, compared with never-users of HT, continuous users had a mean Cobb angle that was 4.0 degrees less, in minimally-adjusted models (P=0.01); in fully-adjusted models, the correlation was attenuated to 2.8 degrees (P=0.06).
For CVD, adjusted hazard ratios of 1.16 and 2.30 were seen for hysterectomy without oophorectomy or with previous oophorectomy, respectively.
Based on these findings, the USPSTF concluded that for most postmenopausal women with an intact uterus, combined estrogen and progestin had no net benefit for primary prevention of chronic conditions (D recommendation).
The researchers found that the women assigned to estradiol exhibited blunted cortisol responses to CPT compared with the women in the placebo group (P=0.017) and lesser negative effects of stress on working memory (P=0.048).
Noven announced that CombiPatch (estradiol/norethindrone acetate transdermal system) and Minivelle (estradiol transdermal system) are now readily available following a temporary product shortage.
The researchers found that during the 18-year follow-up, there were 7,489 deaths (1,088 deaths during the intervention phase and 6,401 deaths during postintervention follow-up).
The researchers recommend that women should not generally be treated with menopausal hormone therapy or tibolone following breast cancer, but should optimize lifestyle.
More women are looking toward alternatives like licorice due to, "concerns about the risk of stroke and breast cancer associated with conventional hormone," said Richard B. van Breemen, PhD, and lead author.
The data showed women with an intact uterus did not have a significantly different risk of stroke, invasive breast cancer, colorectal cancer, endometrial cancer, and pulmonary embolism/deep vein thrombosis (PE/DVT) between those who used vaginal estrogen and those who did not.
Local estrogen therapy has been shown to restore vaginal pH and resvascularize the vaginal and urethral mucosa, improving vaginal dryness and mucosal atrophy.
Intrarosa contains prasterone, an inactive precursor that is converted locally into estrogens and androgens (with minimal systemic exposure) to help restore vaginal tissue.