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FDA Approves Oestrogen Vaginal Cream for Moderate to Severe Postmenopausal Dyspareunia
NEW YORK -- November 13, 2008 -- The US Food and Drug Administration has approved a new indication, and a new less frequent twice-daily dosing regimen, for conjugated oestrogens (Premarin) vaginal cream 0.5 g to treat moderate to severe postmenopausal dyspareunia.
"This approval is welcome news, especially when you consider that more than 1 in 4 untreated postmenopausal women experience dyspareunia, a symptom of vulvar and vaginal atrophy, which typically does not subside without treatment," said Gloria Bachmann, MD, Director of the Women's Health Institute, University of Medicine and Dentistry of NJ-Robert Wood Johnson Medical School, New Brunswick, New Jersey.
The approval is based on efficacy results from a multicentre clinical study that included a 12-week randomised, double-blind placebo phase followed by a 40-week open-label phase.
Results from the 12-week phase showed that both low-dose regimens of the vaginal cream (0.5 g daily [21 days on/7 days off] or twice weekly) significantly improved the dyspareunia score versus placebo at 12 weeks.
Endometrial safety was assessed in women who completed the 52-week study period and had evaluable endometrial biopsies. There were no reports of endometrial hyperplasia or endometrial carcinoma in these women in either regimen.
The most commonly reported side effects were headache, infection, abdominal pain, accidental injury, and vaginitis.
SOURCE: Wyeth
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