drugset / Trial / NCT04948151
Multi-Center Study to Evaluate the Efficacy and Safety of Sildenafil Cream (3.6%) in Premenopausal Patients With Female Sexual Arousal Disorder
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study is looking to minimize side effects, while maintaining and potentially improving the therapeutic benefit to patients suffering from Female Sexual Arousal Disorder by providing a topical preparation of Sildenafil locally to the vulvar-vaginal tissue.
Timeline
- Start
- 2021-06-28
- Primary completion
- 2021-12-15
- Completion
- 2021-12-15
Publications
- Johnson I, Thurman AR, Cornell KA, Symonds T, Hatheway J, Friend DR, Goldstein A. 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. J Sex Med. 2024 Sep 3;21(9):787-792. doi: 10.1093/jsxmed/qdae086.
- Johnson I, Thurman AR, Cornell KA, Hatheway J, Dart C, Brainard CP, Friend DR, Goldstein A. Preliminary Efficacy of Topical Sildenafil Cream for the Treatment of Female Sexual Arousal Disorder: A Randomized Controlled Trial. Obstet Gynecol. 2024 Aug 1;144(2):144-152. doi: 10.1097/AOG.0000000000005648. Epub 2024 Jun 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sildenafil | Unknown | 2 g | Topical |