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DT56a (Femarelle) effectively manages vulvovaginal atrophy in postmenopausal women
Margaret Nachtigall1, Lila E Nachtigall1
1Department of Obstetrics and Gynecology, NYU Interdisciplinary Program in Menopausal Medicine, New York University School of Medicine, New York, NY, USA.
Objective:
To examine the effect of DT56a (Femarelle®), a non-hormonal oral treatment for the management of menopause, on symptoms of vulvovaginal atrophy (VVA)/genitourinary syndrome of menopause (GSM) in postmenopausal women.
Methods:
Twelve (n = 12) postmenopausal women with severe VVA (100% parabasal cells on cervical cytology) and at least one severe VVA symptom were recruited for a 12-week open-label pilot study. At baseline and week 12, participants underwent physical examination, Pap smear, vaginal ultrasound, vaginal cultures, vaginal pH assessment, and vaginal maturation index evaluation. Subjects also completed questionnaires assessing atrophy symptoms and quality of life using the Utian Quality of Life (UQoL) scale. Follow-up at 24 months was available for several participants.
Results:
After 12 weeks of treatment, all patients showed a significant reduction in vaginal pH. In addition, 11 of the 12 women demonstrated significant improvement in the vaginal maturation index and UQoL questionnaire scores.
Conclusions:
DT56a significantly improved subjective and objective parameters of VVA/GSM, including vaginal pH, vaginal maturation index, and quality of life. These findings support its potential role as a non-hormonal systemic treatment option for women with VVA/GSM.
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