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Label indication VIAGRA is indicated for the treatment of erectile dysfunction. VIAGRA is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) ( 1 ) FDA label
Sildenafil · 1 trial · 1 indication
To evaluate and compare the impact of 2 grams of Sildenafil Cream 3.6%, Placebo Cream and Vehicle Cream on vulvar blood flow, as assessed by thermography in normal healthy premenopausal women.
| Arm | Type | Description |
|---|---|---|
| Sildenafil Cream, 3.6% | ACTIVE_COMPARATOR | Contains both Sildenafil and L-arginine |
| Placebo Cream | PLACEBO_COMPARATOR | Contains L-arginine, no Sildenafil |
| Vehicle Cream | OTHER | Contains no L-arginine, no Sildenafil |
| Name | Type | Description |
|---|---|---|
| Sildenafil | DRUG | Sildenafil Cream, 3.6% |
| Vehicle | DRUG | No Active or experimental ingredients |
| Placebo | DRUG | Cream with only L-arginine |
Inclusion Criteria: * Subject must be a premenopausal woman at least 18 years of age. * Subject must be willing to avoid high protein meals and follow dietary guidance provided by the study site staff for the duration of the study. * Women of childbearing potential must be using an acceptable form ...
Sildenafil is being developed by Dare Bioscience, Inc. as a cream formulation for Sexual Arousal Disorder in women. It is in Phase 1 clinical development and is not FDA approved for this indication. The investigational cream is designed for topical application and has been studied in a completed Phase 1 trial.
Sildenafil targets PDE5A, an enzyme known as phosphodiesterase type 5. It acts as a PDE5A inhibitor. By inhibiting this enzyme, sildenafil affects the cyclic GMP signaling pathway, which is relevant to vascular and arousal responses. This mechanism underlies its investigation in Sexual Arousal Disorder.
Dare Bioscience, Inc. is developing Sildenafil for Sexual Arousal Disorder. The company trades under the ticker DARE. Dare Bioscience is focused on women's health and is advancing this investigational cream formulation through clinical development.
Sildenafil is in Phase 1 clinical development for Sexual Arousal Disorder. It is investigational and has not been approved by the FDA for this indication. The Phase 1 program includes one completed trial, and no active trials are currently listed.
Sildenafil has been studied in a completed Phase 1 trial, NCT05765487, titled 'Using Thermography to Assess the Affects of Sildenafil Cream, 3.6%.' The trial enrolled 13 female participants in Canada, was randomized, double-blind, and placebo-controlled. It included healthy volunteers aged 18 years and older.