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Phosphodiesterase Type 5 (PDE5) Inhibitor

Multi-Center Study to Evaluate the Efficacy and Safety of Sildenafil Cream (3.6%) in Premenopausal Patients With 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
Approved for 5 Other Conditions
All Individual Drugs Already Approved

Summary

This trial aims to help women with Female Sexual Arousal Disorder by using a cream or gel with Sildenafil applied directly to the genital area. This method hopes to improve sexual arousal while reducing side effects by targeting the treatment locally. Sildenafil, originally used to treat male erectile dysfunction, has been studied for its potential benefits in treating female sexual arousal disorder (FSAD).

Eligible Conditions
  • Female Sexual Arousal Disorder

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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and sfq28 score at the end of the single-blind placebo run-in to the end of the 12-week double-blind dosing period. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
FSDS-DAO (Q14) - 28 Day Recall
SFQ28 (AS) - 28 Day Recall
Secondary study objectives
Arousal Diary (SSE)

Side effects data

From 2018 Phase 4 trial • 6 Patients • NCT01642407
50%
Bronchitis
50%
Nasopharyngitis
50%
Upper respiratory tract infection
33%
Headache
33%
Epistaxis
33%
Diarrhoea
33%
Gastroenteritis
17%
Eczema
17%
Vision blurred
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

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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
10 Previous Clinical Trials
1,205 Total Patients Enrolled
~100 spots leftby Dec 2025
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