In postmenopausal women with moderate to severe vulvar and vaginal atrophy, a vaginal softgel suppository containing estradiol was a safe and effective treatment option and yielded lower systemic estrogen absorption compared with currently available intravaginal treatments, study results show.
James H. Pickar, MD, an adjunct associate professor of obstetrics and gynecology at Columbia University Medical Center, and colleagues evaluated 50 postmenopausal women aged 40 to 75 years with at least one moderate to severe vulvar and vaginal atrophy symptom randomly assigned to 10 µg vaginal estradiol softgel capsules (TX-004HR, TherapeuticsMD Inc.; n = 24) or placebo (n = 26) administered intravaginally once daily for 14 days.
James H. Pickar
From baseline to day 15, prevalence of superficial cells increased more in the treatment group (35.2 percentage points) compared with the placebo group (8.75 percentage points; P = .0002), and percentage of intermediate cells increased more in the treatment group (18.7 percentage points) compared with placebo (–3.54 percentage points; P = .0017). Parabasal cell prevalence decreased more in the treatment group (–54.4 percentage points) compared with the placebo group (–4.8; P < .0001); similarly, vaginal pH decreased more in the treatment group (–0.974) compared with the placebo group (–0.339; P = .0002).
No significant differences were found between the groups for severity of the most bothersome vulvar and vaginal atrophy symptoms. The treatment group yielded greater mean decreases in vaginal epithelial integrity (treatment group, –0.342 vs. placebo, 0.176; P = .0001) and vaginal secretions (–0.643 vs. –0.274; P = .0401).
Overall, 28% of participants experienced adverse events, but no serious adverse events were reported.
“Vaginal estradiol softgels provide practitioners a new option for local treatment of postmenopausal women with moderate-to-severe vulvar and vaginal atrophy with lower systemic estrogen absorption than other current local estrogen products,” Pickar told Endocrine Today. “There appears to be a good local response with estrogen at very low levels and a better patient user experience, providing physicians and their patients an alternative therapy, if approved for local treamtnet.” – by Amber Cox
Pickar reports various financial ties with Besins Healthcare, Metagenics, Shionogi Inc., TherapeuticsMD and Wyeth/Pfizer. Please see the full study for a list of all other authors’ relevant financial disclosures.