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Vaginal tamoxifen capsule, potential new hormone-free treatment for women with postmenopausal vulvovaginal atrophy
![Vaginal tamoxifen capsule, potential new hormone-free treatment for women with postmenopausal vulvovaginal atrophy Vaginal tamoxifen capsule, potential new hormone-free treatment for women with postmenopausal vulvovaginal atrophy](https://medicaldialogues.in/h-upload/2023/06/27/750x450_212887-vulvovaginal-atrophy.webp)
USA: Vaginal tamoxifen capsule (DARE-VVA1) is safe, and results in minimal systemic exposure to tamoxifen in postmenopausal women with moderate to severe vulvovaginal atrophy (VVA), a phase 1/2 clinical study has shown. The findings were published in the International Menopause Society's journal, Climacteric.
DARE-VVA1, a vaginal tamoxifen capsule (Daré Bioscience), is a soft gelatin capsule containing tamoxifen for vulvovaginal atrophy treatment without hormones in postmenopausal women. Daré is developing DARE-VVA1 as a hormone-free alternative to estrogen-based therapies for treating moderate to severe VVA.
"The data from the study demonstrated safety and tolerability of our investigational product DARE-VVA1, as well as showed an improvement in vaginal cytology parameters and the bothersome vaginal symptoms commonly associated with vulvovaginal atrophy." Andrea Thurman, MD, medical director for Daré Bioscience, said in a related press release.
The team led by Dr Thurman set out to measure the safety, systemic pharmacokinetics and preliminary efficacy of DARE-VVA1 among postmenopausal women with moderate-to-severe vulvovaginal atrophy.
The researchers enrolled 17 postmenopausal women with moderate to severe vulvovaginal atrophy in the randomized, placebo-controlled, double-masked, phase 1/2 study of DARE-VVA1. They were randomly assigned to DARE-VVA1 at 1 mg (n = 3), 5 mg (n = 4), 10 mg (n = 3) and 20 mg (n = 3). 14 women completed the 8-week treatment. DARE-VVA1 was self-administered once daily for the first two weeks and then twice weekly for the remaining six weeks.
The authors reported the following findings:
- DARE-VVA1 was safe. All adverse events were of mild or moderate severity and distributed similarly among active and placebo groups.
- Plasma tamoxifen concentrations were highest among women using DARE-VVA1 20 mg, but the maximum mean (standard deviation) plasma tamoxifen concentrations on day 1 (2.66 ± 0.85 ng/ml) and day 56 (5.69 ± 1.87 ng/ml) were <14% of those measured after one oral tamoxifen dose.
- Active study product users had significant decreases from the pre-treatment baseline in vaginal pH and proportion of vaginal parabasal cells, with women randomized to the 10 mg or 20 mg dose experiencing the most considerable treatment impact.
- The severity of vaginal dryness and dyspareunia decreased significantly from baseline with active study product use.
"The unmet need for an effective non-hormonal treatment for VVA caused by anti-cancer endocrine therapy in patients diagnosed with HR+ breast cancer is undeniable," Sabrina Martucci Johnson, president and CEO of Daré Bioscience, said in the release.
"The current lineup of estrogen-based therapies, commonly used to treat VVA in non-cancer patients, can be challenging for both HR+ breast cancer patients and their providers as the use of estrogen products, in any form, is often contraindicated for the HR+ breast cancer patient population. "If we are successful, vaginally-administered, hormone-free DARE-VVA1 will offer patients and providers an important new treatment option to address one of the most common vaginal side effects associated with breast cancer therapy."
Reference:
A. Thurman, L. Hull, B. Stuckey, J. Hatheway, C. Mauck, N. Zack & D. Friend (2023) Pharmacokinetics, safety and preliminary pharmacodynamic evaluation of DARE-VVA1: a soft gelatin capsule containing tamoxifen for the treatment of vulvovaginal atrophy, Climacteric, DOI: 10.1080/13697137.2023.2211763
MSc. Biotechnology
Medha Baranwal joined Medical Dialogues as an Editor in 2018 for Speciality Medical Dialogues. She covers several medical specialties including Cardiac Sciences, Dentistry, Diabetes and Endo, Diagnostics, ENT, Gastroenterology, Neurosciences, and Radiology. She has completed her Bachelors in Biomedical Sciences from DU and then pursued Masters in Biotechnology from Amity University. She has a working experience of 5 years in the field of medical research writing, scientific writing, content writing, and content management. She can be contacted at  editorial@medicaldialogues.in. Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: editorial@medicaldialogues.in. Contact no. 011-43720751