Daré Bioscience has published the results of a phase ½ trial on DARE-HRT1, indicating efficacy against moderate-to-severe vasomotor symptoms.
Positive results of a phase ½ clinical trial evaluating the efficacy of DARE-HRT1 in postmenopausal women with moderate-to-severe vasomotor symptoms (VMS) have been published in the journal Menopause, according to Daré Bioscience.1
Symptoms of menopause often affect women’s quality of life, with night sweats disturbing sleep and vaginal dryness causing pain or soreness during vaginal intercourse. According to The Menopause Society, hormone therapy is the most effective treatment for VMS, and non-oral therapy may offer benefits over oral therapy.
DARE-HRT1 is an estradiol and progesterone therapy with existing safety and efficacy data. Daré Bioscience plans to obtain marketing approval for the therapy through the FDA’s 505(b)(2) pathway. The phase ½ study evaluated the acceptability, usability, and preliminary efficacy of DARE-HRT1 in 2 dose configurations.
The primary objectives of the study were the safety and efficacy of 2 DARE-HRT1 regimens over a 12-week period.2 Participants included healthy postmenopausal women with an intact uterus not taking exogenous hormones. Menopause was defined as spontaneous amenorrhea for 12 months or for 6 months with a serum follicle-stimulating hormone concentration of 40 mIU/mL or higher.
Participants were treated with an estradiol (E2)-only intravaginal ring (IVR). Treatment occurred over 3 28-day cycles, with a new IVR being inserted at the start of each cycle. The IVR was supplied as E2 80 μg/d with progesterone 4 mg/d for IVR1 and E2 160 μg/d for IVR2.
There were 21 postmenopausal women included in the study, 19 of whom completed all 3 IVR cycles. When reporting their most bothersome genitourinary symptom (MBS), 14 reported vaginal dryness, 3 vaginal pain, and 2 vaginal itching.
For patients with vaginal dryness as their MBS, the median severity score was 2 at baseline and 0 by the end of treatment. The median severity of dyspareunia also decreased from a score of 2 to 0. Symptom reduction was found in both IVR groups.
“We are encouraged by the findings from this study as we believe DARE-HRT1 has the ability to address a persistent unmet medical need,” said Andrea Thurman, MD, medical director for Daré Bioscience and lead author of the journal article.1 “In this study, preliminary VMS treatment efficacy was supported by significant decreases from baseline in all domains of the Menopause-Specific Quality of Life (MENQOL) questionnaire for both dosing groups.”
The results of the MENQOL questionnaire were supported by significant improvements in vaginal cytology parameters, indicating efficacy from DARE-HRT1. Following these results, Daré Bioscience plans to conduct a phase 3 trial of DARE-HRT1.
Daré Bioscience announces publication in the journal of the North American Menopause Society of positive efficacy findings for the treatment of menopausal symptoms from a phase 1/2 clinical trial of DARE-HRT1 intravaginal rings. Daré Bioscience. August 9, 2023. Accessed August 9, 2023. https://ir.darebioscience.com/news-releases/news-release-details/dare-bioscience-announces-publication-journal-north-american