tamoxifen vaginal (DARE-VVA1) / Daré Biosci - LARVOL DELTA

Endometrial Polyp and Vaginal Superficial Myofibroblastoma following Tamoxifen Use: A Case Study. (PubMed, J Menopausal Med) - "We report a rare case of a 51-year-old woman who developed both an endometrial polyp and a vaginal superficial myofibroblastoma after approximately 4 years of tamoxifen therapy. This case emphasizes the importance of long-term gynecologic surveillance in patients receiving tamoxifen treatment."

Journal • Breast Cancer • Endometrial Cancer • Gynecology • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Vaginal Cancer • Women's Health

Longitudinal vaginal microbiomes and quality-of-life patterns during tamoxifen therapy in breast cancer: a pilot study. (PubMed, Sci Rep) - "In this small hypothesis-generating pilot cohort, women receiving tamoxifen showed largely stable overall vaginal community composition over 6 months, with an exploratory signal of G. vaginalis expansion among participants colonized at baseline. These findings should be interpreted cautiously given the small sample size, absence of a control group, treatment heterogeneity, and post hoc subgroup analysis, and require validation in larger controlled cohorts."

HEOR • Journal • Breast Cancer • Oncology • Solid Tumor

The effect of vaginal tamoxifen on symptoms of anxiety, depression, and health-related quality of life in postmenopausal women with and without breast cancer. (PubMed, Maturitas) - "Compared with placebo, weekly vaginal tamoxifen was associated with reduced anxiety symptoms and clinically relevant reduction in overall pain. Although anxiety levels were in the non-clinical range, these changes may still be meaningful for individuals. Further research is needed to clarify the mechanisms and broader benefits of vaginal tamoxifen in postmenopausal women with and without breast cancer."

HEOR • Journal • Breast Cancer • CNS Disorders • Depression • Mood Disorders • Oncology • Pain • Psychiatry • Solid Tumor • Women's Health

Vaginal tamoxifen - A potential treatment option for vaginal atrophy symptoms in postmenopausal women who cannot use estrogen. (PubMed, Eur J Cancer) - "This study has demonstrated that more than two-thirds of the women on vaginal tamoxifen improved in their most troublesome VVA symptom. This is likely due to a tamoxifen-induced estrogen agonistic effects in vagina in a low-estrogen environment. While findings are promising, further studies on improved vaginal administration and endometrial safety concerns are needed."

Journal • Breast Cancer • Oncology • Pain • Solid Tumor • Vaginal Atrophy • Women's Health

Vaginal health in breast cancer survivors: a practical clinical approach. (PubMed, Ther Adv Med Oncol) - "Our review details the genitourinary hypoestrogenic state, its effects on the genitourinary system, its diagnosis, as well as the safety, effectiveness, and available treatment options for BC patients. Furthermore, we offer practical recommendations for managing vulvovaginal symptoms, considering underlying mechanisms and the safe use of topical estrogen, with attention to receptor and cancer status."

Journal • Review • Breast Cancer • Oncology • Solid Tumor • Vaginal Atrophy • Women's Health

39-WEEK INTRA-VAGINAL TAMOXIFEN (DARE-VVA1) DOSE TOXICITY AND TOXICOKINETICS STUDY IN THE RABBIT (ASRM 2024) - "The No-Observed-Adverse-Effect-Level (NOAEL) of tamoxifen was considered to be 30 mg/g day. IMPACT STATEMENT Data from these pre-clinical studies, among others, support clinical testing among women with genitourinary syndrome of menopause."

Preclinical • Dermatology • Hematological Disorders • Ophthalmology • Women's Health

DARE-VVA1: Study of Intravaginal Tamoxifen in PostMenopausal Women With VVA (clinicaltrials.gov) - P1/2 | N=17 | Completed | Sponsor: Daré Bioscience, Inc. | Active, not recruiting ➔ Completed

Trial completion • Solid Tumor • Vaginal Atrophy • Women's Health

Pharmacokinetics, safety and preliminary pharmacodynamic evaluation of DARE-VVA1: a soft gelatin capsule containing tamoxifen for the treatment of vulvovaginal atrophy. (PubMed, Climacteric) - "DARE-VVA1 is safe and results in minimal systemic exposure to tamoxifen. Preliminary efficacy data support further development of this product."

Journal • PK/PD data • Vaginal Atrophy • Women's Health

DARE-VVA1: Study of Intravaginal Tamoxifen in PostMenopausal Women With VVA (clinicaltrials.gov) - P1/2 | N=17 | Active, not recruiting | Sponsor: Daré Bioscience, Inc. | Recruiting ➔ Active, not recruiting | N=40 ➔ 17 | Trial completion date: Dec 2022 ➔ Mar 2023

Enrollment change • Enrollment closed • Trial completion date • Solid Tumor • Vaginal Atrophy • Women's Health

Dare Bioscience Announces Positive Topline Results from DARE-VVA1 Phase 1/2 Clinical Study (GlobeNewswire) - P1/2 | N=40 | DARE-VVA1 (NCT05378269) | Sponsor: Daré Bioscience, Inc. | "The primary outcomes of this first-in-woman study were safety and plasma PK. Intravaginal administration of DARE-VVA1 was well tolerated and all treatment emergent adverse events were mild or moderate and equally distributed between participants randomized to study drug treatment versus placebo....Participants who received study drug treatment (at 1 mg, 5 mg, 10 mg or 20 mg doses) had improvements in the assessments and symptoms associated with VVA – specifically, they had decreases in vaginal pH, increases in the percentage of vaginal superficial cells, significant (p=0.04) decreases in the percentage of vaginal parabasal cells (despite the small sample size), and reduction in their self-assessed most bothersome vaginal symptom reported (either vaginal dryness or pain with intercourse)."

P1/2 data • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Vaginal Atrophy

DARE-VVA1: Study of Intravaginal Tamoxifen in PostMenopausal Women With VVA (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: Daré Bioscience, Inc.

New P1/2 trial • Cervical Cancer • Solid Tumor • Vaginal Atrophy • Women's Health