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Phosphodiesterase Inhibitor

Sildenafil Cream for Sexual Arousal Disorders

Phase 1
Recruiting
Research Sponsored by Daré Bioscience, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days

Summary

This trial is testing three different creams on healthy premenopausal women to see if they can increase blood flow and temperature in the genital area. One cream contains Sildenafil, another contains L-arginine, and the third is a non-active cream. Sildenafil has been used previously in various forms to enhance blood flow in different contexts, including sexual dysfunction and pain management.

Who is the study for?
Premenopausal women over 18, with a BMI <38 kg/m², not pregnant or nursing, using birth control (excluding condoms alone), in good health, non-smokers for at least 24 hours before visits. Must be sexually active and aroused by heterosexual pornography. Cannot have certain cardiovascular diseases, bleeding disorders, significant medical conditions or use genital HRT within three months.
What is being tested?
The trial tests the effects of Sildenafil Cream versus placebo on genital temperature changes in healthy premenopausal women as measured by thermography after watching explicit videos. It aims to assess sexual arousal response through skin temperature variations.
What are the potential side effects?
Potential side effects are not detailed but may include typical reactions to topical creams such as irritation or allergic responses at the site of application. Systemic side effects could mirror those of oral sildenafil: headache, flushing, indigestion.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate the difference in vulvar blood flow after the use of investigational products

Side effects data

From 2015 Phase 3 trial • 155 Patients • NCT01737762
14%
Skin ulcer
10%
Cellulitis
5%
Wound complication
4%
Pain in extremity
4%
Muscle spasms
4%
Wound infecton
3%
Infected skin ulcer
1%
Peripheral ischemia
1%
Sepsis
1%
Skin infection
1%
Fall
1%
Rib fracture
1%
Encephalopathy
1%
Renal failure acute
1%
Urinary retention
100%
80%
60%
40%
20%
0%
Study treatment Arm
HP802-247
Vehicle

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Vehicle CreamExperimental Treatment1 Intervention
Contains no L-arginine, no Sildenafil
Group II: Sildenafil Cream, 3.6%Active Control1 Intervention
Contains both Sildenafil and L-arginine
Group III: Placebo CreamPlacebo Group1 Intervention
Contains L-arginine, no Sildenafil
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vehicle
2013
Completed Phase 3
~5070

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Daré Bioscience, Inc.Lead Sponsor
10 Previous Clinical Trials
1,630 Total Patients Enrolled
Strategic Science & Technologies, LLCIndustry Sponsor
9 Previous Clinical Trials
1,134 Total Patients Enrolled

Media Library

Sildenafil (Phosphodiesterase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05765487 — Phase 1
Sexual Arousal Disorders Research Study Groups: Sildenafil Cream, 3.6%, Placebo Cream, Vehicle Cream
Sexual Arousal Disorders Clinical Trial 2023: Sildenafil Highlights & Side Effects. Trial Name: NCT05765487 — Phase 1
Sildenafil (Phosphodiesterase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05765487 — Phase 1
~6 spots leftby Nov 2025
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