Wyeth Pharmaceuticals, a division of Wyeth, announced the publication of data that supported daily and twice-weekly use of Premarin (conjugated estrogens) Vaginal Cream 0.5 g to relieve some of the bothersome symptoms of moderate-to-severe vulvar and vaginal atrophy, including painful intercourse (dyspareunia).
This study evaluated the efficacy of two low-dose regimens of conjugated estrogens (CE) cream (0.5 g daily and twice weekly) using a double-blind, placebo-controlled study design for 12 weeks followed by a 40-week open-label phase. Endometrial safety for both dosing regimens was also assessed in women who completed 52 weeks of therapy. These study results are published in the July/August issue of Menopause: The Journal of the North American Menopause Society.
In this study, dyspareunia was the most bothersome symptom at baseline (57 per cent) followed by vaginal dryness, itching and burning. Unlike hot flashes or night sweats, signs and symptoms of vaginal atrophy have been shown to increase over time in postmenopausal women.
"Based on market research data, we understand that many postmenopausal women are not discussing their symptoms with their health care professionals," says Gloria Bachmann, M.D., lead study author and director of the Women's Health Institute at the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, New Jersey, and chief of the OB/GYN service at the teaching hospital. "We are encouraged by this 52-week data that showed twice-weekly use of Premarin Vaginal Cream was sufficient to provide relief from painful intercourse due to menopause. The study also supported daily use of Premarin Vaginal Cream 0.5 g to treat postmenopausal vaginal dryness. This information should aid postmenopausal women and their health care professionals in discussing whether and how they may treat vaginal atrophy."
In this multicenter clinical study, 423 postmenopausal women (ages 45-80 years) with moderate-to-severe vaginal atrophy were randomized to receive Premarin Vaginal Cream 0.5 g (equivalent to a low-dose of CE cream 0.3 mg) or placebo once daily (21 days on/7 days off) or twice weekly for 12 weeks. Treatment regimens were consistent within the 12-week and 40-week periods. The primary endpoints of the study were changes in vaginal maturation index (VMI; percentage of superficial cells), vaginal pH and severity of participant-reported most bothersome symptom (vaginal dryness, itching, burning or dyspareunia) at week 12. The study also evaluated safety related to systemic effects of CE cream on endometrial tissue during one year of therapy.
At week 12, improvements in VMI and vaginal pH with daily and twice-weekly use of Premarin Vaginal Cream 0.5 g were significantly greater relative to placebo (P<0.001). Results from the 12-week phase also showed that both low-dose regimens of Premarin Vaginal Cream (0.5 g daily and twice weekly) significantly improved the most bothersome symptoms score versus placebo at 12 weeks (P=0.001), including those for dyspareunia (P=0.01).
After 52 weeks of therapy, with the same respective dosing regimens as in the double-blind phase, results were similar to those observed at week 12 and demonstrated the efficacy of Premarin Vaginal Cream versus placebo. 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. In this study, the most common treatment emergent AE's were headache, infection, arthralgia and vaginitis.
Premarin Vaginal Cream is used to treat menopausal changes in and around the vagina and painful intercourse caused by these changes. Menopause can cause changes in the vaginal tissue, resulting in uncomfortable symptoms. Premarin Vaginal Cream treats the underlying cause of many of these symptoms and can restore the tissues that provide elasticity and lubrication with a low-dose and low-cream volume. Premarin Vaginal Cream is only available by prescription.
Dyspareunia, or pain experienced during sexual intercourse, can be a bothersome symptom of vulvar and vaginal atrophy. Based on a survey of 200 women transitioning through menopause, approximately one in three reported experiencing dyspareunia. Dyspareunia typically does not subside without treatment.