AU2012204083B2 — DHEA compositions for treating menopause

USPTO Abstract

- 97 Novel methods for treating or reducing the likelihood of acquiring symptoms or diseases due to the menopause, in postmenopausal women, particularly osteoporosis, 5 vaginal atrophy and dryness, hypogonadism, diminished libido, skin atrophy, connective tissue disease, urinary incontinence, breast, endometrial, ovarian and uterine cancers, hot flashes, loss of muscle mass, insulin resistance, fatigue, loss of energy, aging, physical symptoms of menopause, in susceptible warm-blooded animals including humans involving administration of a sex steroid precursor are disclosed. Said 10 method comprising novel ways of administering and dosing dehydroepiandrosterone (DHEA) in order to take advantage of positive androgenic effects in the vaginal layers lamina propia and/or the layer muscularis, without undesirably causing systemic estrogenic effects in order to avoid the risk of breast and uterine cancer. Pharmaceutical compositions for delivery of active ingredient(s) useful to the invention are disclosed. Mean Change from Baseline (Day 1) By Treatment in Most Bothersome Symptom 1.8 p<O.OOO1 0 14 days+ 1.6 14 weeks p=0.004 +P=O.0008 k- 1.6- E3 4 weeks (versus placebo) u 1.4 ||12 E 0) z 0.2 0% 0.25% 0.5% 1.0% DHEA Dose Group FL130608-1S