COLLEGEVILLE, Pa., Nov. 14 -- The FDA has approved conjugated estrogen cream (Premarin) to treat dyspareunia under a less-frequent dosing regimen, drug maker Wyeth Pharmaceuticals announced.
The 0.5-g dose can be given twice a week to treat moderate to severe pain during intercourse in postmenopausal women, the company said.
The cream was previously approved for use in a 21 days on/7 days off regimen to relieve vaginal dryness.
The approval follows the results of a 12-week multicenter randomized double-blind trial that included a 40-week open-label follow-up.
In the initial trial, conjugated estrogen cream significantly improved dyspareunia score compared with placebo at 12 weeks.
After 52 weeks, there were no reports of endometrial hyperplasia or endometrial carcinoma among women on either regimen, according to the company.
The most common side effects were headache, infection, abdominal pain, accidental injury, and vaginitis.
Wyeth said patients should not use the cream if they have unusual vaginal bleeding, allergies to any of the ingredients, or present or past breast or uterine cancer, stroke, or heart attack. Women who may be pregnant should not use the cream.
Dyspareunia -- a symptom of vulvar and vaginal atrophy that typically doesn't subside without treatment -- occurs in more than one in four postmenopausal women, the drug maker said.
The tablet form of the drug is currently approved as daily hormone therapy for menopause.