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

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