Plant-Derived Synthetic Conjugated Oestrogens-A Relieve Vaginal-Atrophy Symptoms: Presented at NAMS

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Title: Plant-Derived Synthetic Conjugated Oestrogens-A Relieve Vaginal-Atrophy Symptoms: Presented at NAMS
URL: http://www.pslgroup.com/dg/22DD3E.htm
Doctor's Guide
September 29, 2008

By Deborah Brauser

ORLANDO, Fla -- September 29, 2008 -- Twice-weekly doses of synthetic conjugated oestrogens A (SCE-A) vaginal cream demonstrated marked improvement in the symptoms of vulvovaginal atrophy (VVA), according to results from 2 similar phase 3 trials -- one investigator-assessed and the other patient-assessed -- presented here at the North American Menopause Society (NAMS) 19th Annual Meeting.

David Portman, MD, Columbus Center for Women's Health Research, Columbus, Ohio, reported the results of the investigator-assessed trial at a poster presentation on September 25. In his study, the effects of SCE-A were evaluated and shown to be effective on 7 clinical signs of VVA.

In this 4-arm, double-blind, multicentre, 12-week study, 622 postmenopausal women with VVA were randomised to SCE-A vaginal cream in 1- (n = 150) or 2-g doses (n = 161) or a placebo in 1- (n = 155) or 2-g doses (n = 156). All doses were applied daily for 7 days, and then twice weekly for the trial's remaining 12 weeks.

The investigators then measured the mean change in severity of 7 VVA signs using a 0 to 3 rating scale (0 = none, 3 = severe); measurements were taken at baseline and on weeks 2, 3, 4, 8, and 12. The clinical signs assessed were vaginal atrophy, color, dryness, rugosity, blanching, tissue integrity/friability, and tissue petechiae.

The results showed statistically significant reductions in severity in all 7 clinical signs at each postbaseline visit (including as early as 2 weeks) for both dose groups using the SCE-A cream compared with the placebo groups. Reductions in severity from baseline to end of treatment were highly statistically significant (P < .0001) in all 7 symptoms.

In addition, highly statistically significant (P < .0001) differences were observed in vaginal color, dryness, tissue integrity, and petechiae between both the SCE-A vaginal cream groups and the matching placebo group at all treatment points. Highly statistically significant (P < .0001) differences were also observed at all 2-g-dose timepoints for vaginal atrophy, rugosity, and blanching.

Said Dr. Portman, "Not only did we find that both treatment doses improved all clinical signs of vaginal atrophy, but there was also a much healthier appearance [according to the observing clinicians] … and hopefully relief of the patient's symptoms, including pain with intercourse and vaginal dryness."

"Vaginal oestrogens have been available for quite some time," Dr. Portman noted. "There are animal-derived products that are currently available in the form of conjugated equine oestrogens, but some patients find that particular cream problematic from either a social or a manufacturing standpoint. Knowing that the blend of conjugated oestrogens is very effective in treating vaginal mucosa and vaginal dryness in menopause, it was felt that a plant-derived oestrogen product would be beneficial."

Using the same study cohorts, Howard Hait, MS, Duramed Pharmaceuticals, Bala Cynwyd, Pennsylvania, had the subjects themselves assess their relief of symptoms. He presented the results of the patient-assessed study here at a poster session on September 25.

The 622 postmenopausal women selfevaluated the effects of the twice weekly 1- and 2-g doses of SCE-A vaginal cream or matching placebo on 5 symptoms of VVA.

"The goal of this study was to look at the symptom that's bothering a patient the most," explained Dr. Hait. "We were actually able to show that it wasn't just 1 symptom that was driving the effectiveness of the treatment, but that all of the symptoms that were being recorded actually showed reduction in severity over time."

In this study, the subjects rated the severity of vaginal dryness, vaginal irritation/itching, vaginal soreness, pain during intercourse, and bleeding after intercourse on a 4-point severity scale over 12 weeks. Mean changes in severity for each symptom were calculated from baseline to each study visit (at weeks 2, 3, 4, 8, and 12/end of treatment).

Each dose of SCE-A cream consistently achieved larger mean reductions than the matching placebo dose in the severity of all 5 symptoms at each study visit from week 3 forward. There was a statistically significant improvement (P < .05) from baseline to the end of treatment for those treated with the SCE-A cream compared with placebo for each symptom except itching/irritation in the 1-g-dose group (P = .058) and bleeding after intercourse in the 2-g-dose group (P = .15).

When asked about the consistent findings between this study and the investigator-assessed study, Dr. Hait replied, "I think it's extremely important in any of these studies to show a large level of agreement between what the doctor is thinking, what he or she finds, and what the subject is actually complaining about. That's what makes for good medicine."

Funding for both trials was provided by Duramed Research, Inc.

[Presentation title: The Effectiveness of Twice-Weekly Synthetic Conjugated Estrogens A, Vaginal Cream on Seven Investigator-Assessed Clinical Signs of Vaginal Atrophy in Postmenopausal Women. Abstract 47]

[Presentation title: The Evaluation of Five Patient-Assessed Individual Symptoms of Vulovaginal Atrophy and Response to Twice-Weekly Synthetic Conjugated Estrogens Vaginal Cream. Abstract 34]

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