Premarin offers solution for painful sex, vaginal dryness, says Wyeth study

Premarin, a gel containing a mixture of female sex hormone oestrogens, from Wyeth offers to relieve some of common symptoms of vaginal dryness and painful intercourse in women.

Painful intercourse, which is known as dyspareunia in medical terms. is a symptom of vaginal atrophy.

Premarin vaginal cream, if used daily or twice-weekly, can effectively soothe some of symptoms of moderate-to-severe vulvar and vaginal atrophy, including painful intercourse, according to a data published by Wyeth Pharmaceuticals, a division of Wyeth.

Premarin vaginal cream treats 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 cause of these symptoms and can restore the tissues that provide elasticity and lubrication with a low-dose and low-cream volume, Wyeth claimed.

Wyeth study evaluated the efficacy of two low-dose 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.

Nearly 60% of the women were having painful intercourse as the most pronounced symptom. This was 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, the study found.

“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,” stated 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.

423 women in the age-group ranging from 45-80 participated in the in this multicenter clinical study. The women 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 Wyeth 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. Wyeth study also evaluated safety related to systemic effects of conjugated oestrogen cream on endometrial tissue during one year of therapy.

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.

Wyeth’s Premarin vaginal gel study results are published in the July/August issue of Menopause: The Journal of the North American Menopause Society.

Painful intercourse

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.

Premarin Vaginal Cream is only available by prescription. Premarin vaginal cream can be applied directly to vaginal tissues. More information on how to apply Premarin vaginal can be found here

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women’s health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.

Wyeth (which is to become part of the world’s largest drug maker Pfizer) is one of the world’s largest research-driven pharmaceutical which develops and markets pharmaceuticals, vaccines, biotechnology products, nutritionals and non-prescription medicines.