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Satisfaction, acceptability high with vaginal estradiol softgel capsules

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February 17, 2017

Postmenopausal women with vulvar and vaginal atrophy reported high satisfaction and acceptability with vaginal estradiol softgel capsules compared with previously used therapies to treat their symptoms, study data show.

“[Vulvar and vaginal atrophy] is a chronic condition associated with genitourinary syndrome of menopause and affects 50% to 70% of postmenopausal women,” Sheryl A. Kingsberg, PhD, division chief, obstetrics and gynecology behavioral medicine, UH Cleveland Medical Center and professor of obstetrics and gynecology and psychiatry, Case Western Reserve University School of Medicine, told Endocrine Today. “Symptoms include pain with sexual activity, dryness and discomfort. Despite safe and effective prescription therapies, [vulvar and vaginal atrophy] remained under-treated. The availability of a new applicator-free delivery system may be one step to increasing discussion of [vulvar and vaginal atrophy] and treatments between women and [health care providers].”

Sheryl Kingsberg
Sheryl A. Kingsberg

Kingsberg and colleagues evaluated data from the phase 3 REJOICE trial on 764 postmenopausal women (mean age, 59 years) with vulvar and vaginal atrophy (32% treatment-naive) randomly assigned to vaginal estradiol softgel capsules (TX-004HR, TherapeuticsMD Inc.) 4 µg (n = 191), 10 µg (n = 191), 25 µg (n = 190) or placebo (n = 192) to determine acceptability and satisfaction with the therapy.

Participants self-administered the therapy or placebo for 10 weeks of biweekly dosing followed by one capsule per day for 2 weeks. Participants completed a five-question acceptability questionnaire at the end of their study participation.

Most participants found the product easy to use (85.4%-92.1%) and rated the ease of insertion as “good” or “excellent” (75%-82.6%). Participants reported more ease of insertion with the estradiol capsules (4 µg, 81.7%; 10 µg, 81.2%; 25 µg, 82.6%) compared with placebo (75%; P < .05).

Ease of product use was associated with changes in dyspareunia severity (P = .0002) and changes in vaginal dryness severity (P < .0001).

More participants in the estradiol-capsule groups reported being “satisfied” or “very satisfied” (4 µg, 68.6%; 10 µg, 72.8%; 25 µg, 76.3%) compared with placebo (56.8%; P = .0009 for 4 µg; P < .0001 for 10 µg and 25 µg).

Among participants who had previously used treatment for vulvar and vaginal atrophy, more participants preferred the estradiol capsules (4 µg, 68.2%; 10 µg, 61.8%; 25 µg, 70.9%) over a previously used treatment compared with those who used placebo (51.9%; P = .001 for 4 µg; P = .0212 for 10 µg; P = .0003 for 25 µg). More participants in the estradiol-capsule groups reported that they would “probably” or “definitely” consider using the product again (72.8%-80.5%) compared with placebo (62.5%).

“The majority of postmenopausal women participating in the REJOICE trail rated using the product and inserting the applicator-free capsule as easy, and when compared with placebo, were more satisfied with TX-004HR, preferred it over their previous [vulvar and vaginal atrophy] treatment and would consider using TX-004HR again,” the researchers wrote. “Together with previously reported improvements in vaginal physiology and severity of dyspareunia, these survey results suggest women prescribed TX-004HR will be satisfied with their vaginal therapy, which may enhance treatment adherence for their postmenopausal [vulvar and vaginal atrophy] and moderate to severe dyspareunia.” – by Amber Cox

Disclosure: Kingsberg reports various financial ties with Acerus Pharmaceuticals, Bayer Healthcare, Emotional Brain, Materna, Novo Nordisk, Nuelle, Palatin Technologies, Pfizer, Sermonix Pharmaceuticals, Shionogi Inc., Sprout Pharmaceuticals, TherapeuticsMD and Valeant Pharmaceuticals. Please see the full study for a list of all other authors’ relevant financial disclosures.

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James Pickar
James H. Pickar
Kingsberg and colleagues addressed some of the concerns that practitioners have when treating symptoms of vulvar and vaginal atrophy. In the 12-week, double blind, randomized, placebo-controlled phase 3 REJOICE trial, the authors obtained data on patient satisfaction with an investigational vaginally inserted softgel estradiol capsule. The study randomized 764 postmenopausal women (aged 40 to 75 years) with a most bothersome symptom of moderate to severe dyspareunia to either a 4-, 10- or 25- µg solubilized estradiol-containing softgel capsule or a placebo softgel capsule. Of these women, 731 (96%) provided answers to a 5-question product acceptability questionnaire administered at week 12. The vast majority found the product easy to use and rated the ease of capsule insertion as “good” or “excellent.” More women reported being “satisfied” or “very satisfied” in the active treatment groups than in the placebo group, and women who had a prior treatment, compared with the placebo group, reported a preference for TX-004HR compared with their previous treatment. A significant majority of women indicated they would “probably” or “definitely” consider using TX-004HR again compared with placebo. This study suggests that this applicator-free approach using a muco-adhesive, solubilized estradiol-containing softgel capsule was well received by the patients participating in this study and addressed many of their concerns with other approaches. As patient satisfaction is a major concern for physicians these findings should be helpful to physicians treating vulvar and vaginal atrophy.

James H. Pickar, MD
Adjunct Associate Professor of Obstetrics and Gynecology, Columbia University Medical Center
Disclosure: Pickar reports serving as a consultant for Radius Health, Shionogi, TherapeuticsMD and Wyeth/Pfizer, and having stock options with TherapeuticsMD.