Ospemifene Pill Improves Several Measures of Sexual Function

June 27, 2013

By Anne Harding

NEW YORK (Reuters Health) Jun 27 - Postmenopausal women taking the dyspareunia drug ospemifene showed significant improvement in all six domains measured in the Female Sexual Function Index (FSFI) after 12 weeks of treatment, investigators said this month at the Endocrine Society's Annual Meeting in San Francisco.

And study participants showed improvement in four of the six domains after four weeks of treatment, Dr. Ginger Constantine of EndoRheum Consultants in Media, Pennsylvania, and her colleagues found.

Shionogi, Inc., which markets the drug as Osphena, funded the study, and two of the researchers on the study are employed by the Florham Park, N.J.-based company.

The drug, approved by the US Food and Drug Administration in February of this year to treat pain during sex in postmenopausal women, is a tissue-selective estrogen receptor modulator that acts on the vaginal epithelium.

From 38% to 50% of postmenopausal women experience dryness and painful sex due to vulvovaginal atrophy, Dr. Constantine noted in an interview with Reuters Health.

Dr. Constantine, who is a consultant to Shionogi, reported at the meeting on an analysis of secondary endpoints from a phase III trial in which 919 women were randomly assigned to 60 mg of oral ospemifene daily or placebo. The study's co-primary endpoints were change from baseline to week 12 in percentage of superficial cells and percent parabasal cells in the maturation index, vaginal pH, and improvement in most bothersome symptom.

Dr. Constantine and her colleagues looked at mean changes from baseline to weeks four and 12 for FSFI total score and for six domains based on patient-assessed sexual function in the questionnaire: desire, arousal, lubrication, orgasm, satisfaction, and pain.

By week 12, the researchers found, there were statistically significant improvements in all six domains (p<0.05). At week four, there was significant improvement in each domain except for orgasm (p=0.0820) and satisfaction (p=0.3206).

"Consistency of effect was observed in all of the domains, which distinguishes ospemifene from other agents that treat dyspareunia," Dr. Constantine and her colleagues write in the abstract of the study. "Confirmation of this data and assessment as to whether these effects are related solely to the improvement in dyspareunia remains to be elucidated."

Dr. Constantine told Reuters Health that while it's not surprising that treating dyspareunia would improve sexual function, other treatments have not shown such a broad effect on the domains of sexual function measured by the FSFI. "What I found really interesting was that all six domains had improvement, which I haven't really seen with any other product," she said.

"Ospemifene is really the first new thing that I can think of to come along in quite some time in women's health," Dr. Steven R. Goldstein, a professor of obstetrics and gynecology at New York University School of Medicine in New York City, told Reuters Health.

Dr. Goldstein, a past president of the North American Menopause Society, helped conduct clinical trials of ospemifene, but did not take part in the current analysis. "Up until now all that was available was estrogen," he added. "This is really the first nonestrogen that significantly treats vulvovaginal atrophy and the dyspareunia it causes."

Dr. Goldstein is a speaker for Shionogi as well as for Warner Chillcott who make Estrace cream (estradiol).

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