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Phosphodiesterase Type 5 (PDE5) Inhibitor
Sildenafil for Female Sexual Arousal Disorder (RESPOND Trial)
Phase 2
Waitlist Available
Research Sponsored by Strategic Science & Technologies, LLC
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 sfq28 score at the end of the single-blind placebo run-in to the end of the 12-week double-blind dosing period.
Awards & highlights
RESPOND Trial Summary
This study is evaluating whether a topical preparation of sildenafil can be used to treat Female Sexual Arousal Disorder.
Eligible Conditions
- Female Sexual Arousal Disorder
RESPOND Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ sfq28 score at the end of the single-blind placebo run-in to the end of the 12-week double-blind dosing period.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~sfq28 score at the end of the single-blind placebo run-in to the end of the 12-week double-blind dosing period.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
FSDS-DAO (Q14) - 28 Day Recall
SFQ28 (AS) - 28 Day Recall
Secondary outcome measures
Arousal Diary (SSE)
Side effects data
From 2018 Phase 4 trial • 6 Patients • NCT0164240750%
Bronchitis
50%
Nasopharyngitis
50%
Upper respiratory tract infection
33%
Headache
33%
Epistaxis
33%
Diarrhoea
33%
Gastroenteritis
17%
Vision blurred
17%
Eczema
17%
Rash
17%
Flushing
17%
Alanine aminotransferase increased
17%
Ammonia increased
17%
Aspartate aminotransferase increased
17%
Weight increased
17%
Dysmenorrhoea
17%
Erection increased
17%
Pulmonary arterial hypertension
17%
Rhinitis allergic
17%
Acne
17%
Dermatitis diaper
17%
Dry skin
17%
Visual acuity reduced transiently
17%
Colitis
17%
Molluscum contagiosum
17%
Streptococcal infection
17%
Blood urine present
17%
Myalgia
17%
Cardiac failure
17%
Conjunctivitis allergic
17%
Dental caries
17%
Vomiting
17%
Chest pain
17%
Feeling abnormal
17%
Influenza
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sildenafil
RESPOND Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sildenafil Cream, 3.6%Experimental Treatment1 Intervention
Group II: Placebo CreamPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sildenafil
FDA approved
Find a Location
Who is running the clinical trial?
Strategic Science & Technologies, LLCLead Sponsor
9 Previous Clinical Trials
709 Total Patients Enrolled
Daré Bioscience, Inc.Industry Sponsor
9 Previous Clinical Trials
1,142 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Suffolk Obstetrics and Gynecology
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
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