Pilot study finds oral SERM improves pain and sexual function

Ospemifene, an oral selective estrogen receptor modulator approved for treatment of mild to moderate dyspareunia in menopausal women, reduced signs and symptoms of atrophy in the vulva, vestibule, urethral meatus and vagina region, according to results of a prospective open-label pilot study in Sexual Medicine.

The eight patients, with a mean age of 59 years (range 21 to 80), took ospemifene 60 mg daily for 20 weeks.

During that time, there were significant changes in urethral meatal prominence, introital stenosis, vestibular pallor, vestibular erythema, mucosal moisture, vaginal regulation and anterior wall prominence.

In addition, total pain score via cotton-tipped swab testing decreased from an average of 12.9 at baseline to 1.9 at the end of the study.

“Examining the vulva, vestibule and vagina by vulvoscopy with photography is standard in sexual medicine practice. This enables a longitudinal assessment of genitourinary tissue health,” said co-author Irwin Goldstein, MD, IF, director of sexual medicine at Alvarado Hospital in San Diego.

“Women who suffer from signs and symptoms of vulvar, vestibular and vaginal atrophy and genitourinary syndrome of menopause (GSM) have classic abnormal findings, such as labia majora and minora atrophy and resorption, clitoral atrophy, urethral meatal protrusion, vestibule pallor and erythema and tenderness, loss of vaginal rugae, vaginal dryness, vaginal pallor, introital stenosis and less robust anterior vaginal wall,” Dr. Goldstein told Contemporary OB/GYN.

However, these anatomic changes, as documented by vulvoscopy with photography in patients with GSM, “were not examined prior to and following the use of ospemifene in the FDA registration trials,” Dr. Goldstein said. “We were interested in seeing if the significant improvements in moderate to severe dyspareunia experienced by the menopausal women using ospemifene would be reflected by changes in the vulvoscopic appearance of the vulva, vestibular and vagina.”

The main findings of this first-ever pilot study were that there were statistically significant improvements, from mild to moderate, in 7 of 10 parameters judged by vulvoscopic photographs: prominence of urethral meatus, stenosis of the introitus, vestibular pallor, vestibular erythema, loss of vestibular moisture, loss of vaginal rugae and loss of prominence of the anterior vaginal wall.

 “Subjects also had decreased pain by examination and patient diary,” Dr. Goldstein said. Quantitative analysis of sexual function diaries indicated that the number of sexual events did not differ significantly before and after invention: 4.5 and 7, respectively. But the percentage of sexual events that showed improvement was significant for three of seven questions. When patients were asked if they felt less dry than before, responses ranged from 75% to 100% less dry at the end of the study, compared to 20% at baseline (range 0% to 82%). Similarly, pain during foreplay decreased from 41.5% at baseline (range 0% to 70%) to 0% at the end of study. Furthermore, pain during intercourse decreased from 80% at baseline (range 20% to 100%) to 0%. On the other hand, for sexual events using lubricant, there was no statistically significant difference: a decrease from 85% (range 50% to 100%) at baseline to 50% (range 16.5% to 91.5%).

No serious adverse events were reported.

“We were excited to document anatomic changes to the vestibule, urethra and anterior vaginal wall, as these tissues are also androgen-dependent,” Dr. Goldstein said. “However, more research is needed to understand the mechanism of action of ospemifene.”

Dr. Goldstein also said use of vulvoscopic photographic images to document anatomic changes in women receiving treatment for GSM should be more widely employed.

Despite the encouraging results of the study, the authors noted that management of women with painful sexual activity is complex and frequently requires an interdisciplinary approach. Non-hormonal biologic factors, musculoskeletal concerns and psychological, social and/or partner factors can also play a role in painful intercourse for women in menopause.

Mindfulness can also alleviate genital pain.

The study was spearheaded by Sue Goldstein, CCRC, CSE, IF, clinical research manager at San Diego Sexual Medicine.

Disclosures:

Dr. Goldstein is a consultant for Shionogi & Company Ltd. and serves on the speaker’s bureau of Duchesnay.