sildenafil cream (SST-6006) / Daré Biosci, Strategic Science & Technologies - LARVOL DELTA

An open-label, single-dose, randomized, parallel-group study of the safety and relative bioavailability of topical sildenafil cream vs oral sildenafil in healthy male adults. (PubMed, Sex Med) - "Topically applied Sildenafil Cream was safe and well tolerated by healthy men. Topical sildenafil cream use was associated with lower systemic exposure compared to oral sildenafil use."

Journal • Cardiovascular • Erectile Dysfunction • Pain

A phase 1, open-label, within-participant dose-escalation study to evaluate the safety and pharmacokinetics of topical sildenafil cream in healthy postmenopausal women. (PubMed, Menopause) - "These data support further clinical development of topical sildenafil cream for the treatment of female sexual arousal disorder in postmenopausal women and are consistent with phase 2b data among premenopausal women and their male sexual partners."

Journal • P1 data • PK/PD data • Hypotension • Sexual Disorders

Using Thermography to Assess the Affects of Sildenafil Cream, 3.6% (clinicaltrials.gov) - P1 | N=13 | Completed | Sponsor: Daré Bioscience, Inc. | Recruiting ➔ Completed | Trial completion date: Jul 2024 ➔ Oct 2024

Trial completion • Trial completion date • Sexual Disorders

Impact of age, race, and medication use on efficacy endpoints in a randomized controlled trial of topical sildenafil cream for the treatment of female sexual arousal disorder. (PubMed, Sex Med) - "Age and hormonal contraceptive use did not impact the efficacy of topical Sildenafil Cream. Daily psychiatric medication use decreased sexual desire in active and placebo users."

Journal • Psychiatry • Sexual Disorders

Safety of topical sildenafil cream, 3.6% in a randomized, placebo-controlled trial for the treatment of female sexual arousal disorder. (PubMed, J Sex Med) - "These data demonstrate that topically applied sildenafil cream was safe and well tolerated by exposed users and their sexual partners."

Journal • Erectile Dysfunction • Sexual Disorders

Comparisons and correlations of 1-month recall vs 24-hour recall in patient-reported outcomes of an exploratory, phase 2b, randomized, double-blind, placebo-controlled clinical trial of sildenafil cream, 3.6% for the treatment of female sexual arousal disorder. (PubMed, J Sex Med) - P2b | "These data will be used in planning future efficacy assessments of sildenafil cream for FSAD."

Clinical • Journal • P2b data • Patient reported outcomes • Sexual Disorders

Preliminary Efficacy of Topical Sildenafil Cream for the Treatment of Female Sexual Arousal Disorder: A Randomized Controlled Trial. (PubMed, Obstet Gynecol) - P2b | "Topical sildenafil cream improved outcomes among women with female sexual arousal disorder, most significantly in those who did not have concomitant orgasmic dysfunction. In particular, in an exploratory analysis of a subset of women with female sexual arousal disorder with or without concomitant decreased desire, topical sildenafil cream increased sexual arousal sensation, desire, and orgasm and reduced sexual distress."

Journal • CNS Disorders • Pain • Sexual Disorders

Using Thermography to Assess the Affects of Sildenafil Cream, 3.6% (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Daré Bioscience, Inc. | Trial completion date: Feb 2024 ➔ Jul 2024 | Trial primary completion date: Dec 2023 ➔ Apr 2024

Trial completion date • Trial primary completion date • Sexual Disorders

Using Thermography to Assess the Affects of Sildenafil Cream, 3.6% (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Daré Bioscience, Inc. | Trial primary completion date: Sep 2023 ➔ Dec 2023

Trial primary completion date • Sexual Disorders

Using Thermography to Assess the Affects of Sildenafil Cream, 3.6% (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Daré Bioscience, Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Jul 2023 ➔ Feb 2024

Enrollment open • Trial completion date • Sexual Disorders

Using Thermography to Assess the Affects of Sildenafil Cream, 3.6% (clinicaltrials.gov) - P1 | N=15 | Not yet recruiting | Sponsor: Daré Bioscience, Inc.

New P1 trial • Sexual Disorders

Daré Bioscience (BIO 2022) - "The company’s mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women's health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, fertility, and vaginal and sexual health. Daré’s product portfolio includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to treat female sexual arousal disorder utilizing the active ingredient in Viagra®; DARE-BV1, a unique hydrogel formulation of clindamycin phosphate 2% to treat bacterial vaginosis via a single application."

Sexual Disorders • Vaginitis • Women's Health