Efficacy and safety of ultra-low-dose Vagifem (10 mcg).

Vulvovaginal atrophy [VVA] is defined as inflammation of the vaginal epithelium due to atrophy secondary to decreased levels of circulating estrogen. There is currently only one approved method for the treatment of VVA, and that is the administration of exogenous estrogens. Overall, the ideal VVA treatment must have benefits, minimize risks, and enhance compliance in the patient while optimizing cost-effectiveness. Unfortunately, of the approximate 25% of symptomatic women that are thought to seek medical help, the proportion that receives hormone therapy may be small and its duration of use is short. Women have been very reluctant to take hormone therapy due to widely publicized results of the risks associated with hormone therapy. Thus, while menopausal hormone therapy was once accepted as the ideal approach for optimizing changes associated with menopause, prospective randomized clinical trials have challenged that view and have led to a marked decrease in the use of such therapy and increased search for low-dose therapies. This article will highlight the efficacy and safety of recently FDA-approved Vagifem (10 mcg) in treatment of VVA.

Update on alternative therapies for vulvovaginal atrophy.

Although systemic absorption of estrogen with local treatment for vulvovaginal atrophy (VVA) is most likely to be negligible, it is unknown whether this minimal absorption will affect outcomes in women with breast cancer. Use of adjuvant therapy with aromatase inhibitors for breast cancer is associated with high incidence of VVA symptoms. Because of the impact of moderate to severe VVA symptoms on the quality of life in breast cancer survivors, there has been an intense search for alternative therapies. Further, the publicity that followed the publication of data from the Women's Health Initiative Study has led to the suggestion by the medical community to use the lowest dose therapy possible for minimal time duration in order to avoid risks. This article will highlight the progress in alternative therapies for VVA.

Efficacy and safety of vaginal estriol and progesterone in postmenopausal women with atrophic vaginitis.

OBJECTIVE: The aim of this study was to assess the efficacy and safety of intravaginal estriol and progesterone on atrophic vaginitis in postmenopausal women. METHODS: Under a physician-sponsored Investigational New Drug application, 19 healthy postmenopausal women with atrophic vaginitis received vaginal suppositories containing estriol (1 mg) and progesterone (30 mg). The participants were instructed to insert one suppository intravaginally once daily for 2 weeks and thrice weekly for a total of 6 months. Vaginal pH, Vaginal Maturation Index, urinalysis, self-reported vaginal dryness, menopausal quality of life, and serum estriol and progesterone levels were measured at enrollment and after 3 and 6 months of suppository use. Endometrial biopsies were obtained at enrollment and at 6 months. After 2 weeks of therapy, six participants had serum estriol and progesterone measured. RESULTS: The Vaginal Maturation Index, vaginal pH, and vaginal dryness rating improved significantly at 3 and 6 months compared with baseline. Menopausal quality of life scores improved significantly in all domains, with the sexual subscale showing the most improvement. There were no cases of endometrial hyperplasia after 6 months of suppository use. Serum preinsertion estriol at week 2 and months 3 and 6 were similar to baseline levels. Serum preinsertion progesterone increased but returned to baseline preinsertion levels at month 6, and preinsertion levels were significantly less at month 6 compared with month 3. CONCLUSIONS: Intravaginal administration of a combination estriol and progesterone agent to women with atrophic vaginitis may represent a safe and effective alternative to systemic hormone replacement, although this study was not adequate to provide proof of efficacy given that it was uncontrolled.