The DARE-HRT1 intravaginal ring effectively decreases vaginal pH and the percentage of parabasal cells, supporting the efficacy of DARE-HRT1A in genitourinary syndrome of menopause, according to a new study.
Vasomotor symptoms, including night sweats and hot flashes, as well as genitourinary symptoms, are commonly experienced by menopausal women. DARE-HRT1 is an intravaginal ring (IVR) that releases estradiol and progesterone over 28 days. This randomized controlled trial aimed to explore the usability, efficacy, and acceptability of DARE-HRT1 in treating vasomotor symptoms and genitourinary syndrome of menopause (GSM) in postmenopausal women with an intact uterus. The findings are published in the journal Menopause.
A total of 21 participants were enrolled in the Australian study, of which 11 and 10 participants were randomized to the DARE-HRT1-IVR1 (E2 80 µg/d with P4 4 mg/d) and DARE-HRT1-IVR2 (E2 160 µg/d with P4 8 mg/d) groups, respectively.
Preliminary Effects on Genitourinary Syndrome of Menopause
Both dosage regimens were associated with a statistically significant improvement in vaginal cytology, with significant decreases in the percentage of parabasal cells and vaginal pH. The most bothersome genitourinary symptoms of participants at baseline were not present towards the end of the treatment. The IVR1 dosing group demonstrated a significant improvement in dyspareunia and vaginal dryness.
Preliminary Effects on Vasomotor Symptoms
The Menopause-Specific Quality of Life (MENQOL) questionnaire scores significantly improved in all domains in both groups, particularly in the sexual domain. The DARE-HRTI-IVR1 participants reported a significant improvement in night sweats and hot flashes but no changes in sweating, while the DARE-HRTI-IVR2 participants reported significant improvements in the severity of sweating, hot flashes, and night sweats.
Usability and Acceptability of DARE-HRT1
The majority of the women in both groups reported the IVR as being comfortable, convenient, and compatible with their lifestyle. The acceptability responses of the participants were comparable between the two groups.
Thurman, A. R., Hull, L., Stuckey, B., Hatheway, J., Zack, N., Mauck, C., & Friend, D. R. (2023). A phase 1/2, open-label, parallel group study to evaluate the preliminary efficacy and usability DARE-HRT1 (80 μg estradiol/4 mg progesterone and 160 μg estradiol/8 mg progesterone intravaginal RinGSM) over 12 weeks in healthy postmenopausal women. Menopause, 30(9), 940–946. https://doi.org/10.1097/gme.0000000000002230