May 23, 2008 -- New research results show that a non-estrogen drug called Ophena significantly improves symptoms of vaginal dryness and painful intercourse in postmenopausal women, raising hopes of an alterative to estrogen replacement therapy.
Vaginal dryness and painful intercourse, or dyspareunia, are two common symptoms of postmenopausal vulvovaginal atrophy -- thinning of the tissue and lining of the vulva and vagina. It affects up to 40% of postmenopausal women in the U.S.
"For millions of postmenopausal women, the symptoms of vulvovaginal atrophy represent a serious health issue that can have a profound negative impact on quality of life," James A. Simon, MD, CCD, FACOG, clinical professor of obstetrics and gynecology at George Washington University, says in a news release.
Over-the-counter non-hormonal lubricants and moisturizers are available to help with symptoms, but the most effective treatments for vulvovaginal atrophy contain the hormone estrogen. Estrogen replacement therapy has been linked to an increased risk of breast cancer, heart disease, and stroke.
Ophena is a type of drug called a selective estrogen receptor modulator (SERM). Pivotal clinical trial results presented this week at the 12th World Congress on the Menopause in Madrid, Spain, show that women who took Ophena tablets for 12 weeks had significant improvements in symptom scores of vaginal dryness and painful intercourse. The study involved 826 postmenopausal women at 80 different medical centers across the U.S. who were randomly assigned to one of two doses of Ophena or a placebo.
"These study results indicate that Ophena has the potential to be the first non-estrogen treatment option that provides a clear clinical benefit. We are working to advance the development program for Ophena to make this important therapy available to all women who would benefit from it," Robert Zerbe, MD, president and chief executive officer of QuatRx, says in the news release.
The researchers say the drug appears to be safe and generally well tolerated.