Investigative Osteoporosis Drug Eases Symptoms of Vaginal Atrophy

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Oporia (lasofoxifene), a selective estrogen receptor modifier (SERM) under investigation for Osteoporosis, seems effective for menopause-associated vaginal atrophy, including dyspareunia, dryness, and vaginal itching.

“Lasofoxifene is the first SERM to show an improvement in the treatment of vaginal atrophy,” investigators reported at the North American Menopause Society meeting here.

“It was very nice to be able to see results quickly,” said investigator Gloria A. Bachmann, M.D., director of the Women’s Health Institute at Robert Wood Johnson Hospital in New Brunswick, N.J. “Even though this study was blinded, you could basically tell who had the treatment and who didn’t, because the results were so markedly different.”

Dr. Bachmann said that she and her co-investigators conducted the study because in Phase II Osteoporosis trials women in the Oporia groups spontaneously reported markedly increased vaginal lubrication.

In the current 12-week phase III study, 445 postmenopausal women, average age 59, with symptomatic vaginal atrophy, were randomized to either placebo or one of two doses of Oporia, 0.25 mg daily or 0.5 mg daily.

The patients reported their vaginal atrophy symptoms on a Likert scale (0 equaled no symptoms; 3, severe symptoms). Reports were collected at baseline and at weeks two, four, eight, and 12.

At the outset, 40% of the women reported that dyspareunia was the most bothersome symptom. The other symptoms reported at baseline included vaginal dryness (31%), dysuria (16%), and vaginal or vulvar itching (13%). The average severity score of the most bothersome symptom was 2.4 across all treatment groups.

At the end of the study, the adjusted average decreases in the severity of the most bothersome vaginal atrophy symptom were 1.3 in the 0.25 mg group, 1.4 in the 0.5 mg group, and 0.9 in the placebo group (p<0.0001).

Some women reported improvement as early as week two, and improvement was statistically significant in comparison with placebo by week eight. The advantage over placebo was sustained throughout the rest of the study.

In addition to self-reports, the investigators assessed vaginal pH at baseline and at follow-up visits, as well as the percentage of vaginal parabasal and superficial cells. At baseline, the average vaginal pH was 6.3. At the end of the study, the vaginal pH had decreased an average of 0.77 pH units in the lower-dose group and 0.86 pH units in the 0.5 mg group. In the placebo group, the average decrease was 0.19 pH units (p<0.00001).

The parabasal cells had decreased an average of 37.5% and 36.8% in the two drug treatment groups, and 3.3% in the placebo group (p<0.00001). The average increase in the superficial cells was 5.9% and 4.7% for the drug groups and 2.5% for the placebo group (p<0.001).

The most commonly reported adverse effects were hot flashes, for 21% of the Oporia patients and 9% of those on placebo. Leg cramps were reported by 8% of those on medication and 1% of those on placebo. Leucorrhea was reported by 10% of those on Oporia and 5% of those on placebo. In addition, 8% of those taking the drug and 7% of those on placebo reported headache.

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