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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
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 • NCT0173776214%
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
9 Previous Clinical Trials
1,570 Total Patients Enrolled
Strategic Science & Technologies, LLCIndustry Sponsor
9 Previous Clinical Trials
1,134 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any infections or conditions that would prevent me from joining the study.I am not pregnant, nursing, or planning to become pregnant during the study.I have a history of specific medical conditions or surgeries.I am a premenopausal woman aged 18 or older.I have used hormone creams on my genitals in the last 3 months.I am in good health for my age, as confirmed by a recent physical and gynecological exam.I have been sexually active in the last 4 weeks.I have taken specific medications within the last month.I am sexually aroused by watching heterosexual pornography.I understand the study requirements and agree to participate.I am willing to trim my pubic hair for accurate genital temperature readings.I have had a Pap smear in the last 3 years with normal results or ASCUS but negative for HPV.I have a bone or joint problem that could affect my participation in the study.I have abnormal findings from my recent gynecological exam.
Research Study Groups:
This trial has the following groups:- Group 1: Sildenafil Cream, 3.6%
- Group 2: Placebo Cream
- Group 3: Vehicle Cream
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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