Multi-Center Study to Evaluate the Efficacy and Safety of Sildenafil Cream (3.6%) in Premenopausal Patients With Female Sexual Arousal Disorder

(RESPOND Trial)

Recruiting at 50 trial locations

Overseen By Kathy Cornell

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Strategic Science & Technologies, LLC

Must not be taking: Guanylate cyclase stimulators, Nitrates

Disqualifiers: Pregnancy, Cardiovascular issues, Diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

440 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must not use vaginal hormone therapy, certain vaginal products, or specific medications like guanylate cyclase stimulators and strong CYP3A4 inhibitors. If you are on systemic therapy, it should be stable for at least 6 months before starting the trial.

What data supports the effectiveness of the drug Sildenafil Cream?

Sildenafil, commonly used in pill form for erectile dysfunction, has shown significant improvements in erectile function in various patient groups, including those with diabetes and cardiovascular issues. This suggests that Sildenafil Cream might also be effective, given its similar active ingredient. ^{1 2 3 4 5}

Is Sildenafil Cream generally safe for humans?

A trial in the Netherlands using oral sildenafil for fetal growth restriction was stopped early due to very harmful side effects to the babies, indicating potential safety concerns. ^{6 7 8 9 10}

How does Sildenafil Cream differ from other drugs for erectile dysfunction?

Sildenafil Cream is unique because it is applied topically, unlike the traditional oral form of sildenafil used for erectile dysfunction. This method of administration may offer a different absorption rate and potentially reduce systemic side effects compared to oral tablets. ^{2 11 12 13 14}

Eligibility Criteria

Inclusion Criteria

Patient is fluent in the English language.

Inclusion Criteria - For Patient Eligibility

Patient must be a premenopausal woman, 21 years or older.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single-Blind Placebo Run-In

Participants receive a placebo cream to establish baseline measurements

4 weeks

Double-Blind Dosing

Participants receive either Sildenafil Cream, 3.6% or placebo to evaluate efficacy and safety

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Sildenafil Cream

Participant Groups

Group I: Sildenafil Cream, 3.6% Experimental Treatment 1 Intervention

Group II: Placebo Cream Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Strategic Science & Technologies, LLC

Lead Sponsor

Trials

10

Recruited

1,100+

Daré Bioscience, Inc.

Industry Sponsor

Trials

11

Recruited

1,600+

Findings from Research

Sildenafil citrate (Viagra) has been prescribed to over 10 million patients and has shown significant improvements in erectile function across various conditions, including diabetes and cardiovascular disease, based on clinical trials.

The medication is generally well-tolerated, with most side effects being mild or moderate and rarely causing patients to stop treatment, indicating its safety in a wide range of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-year update of sildenafil citrate (Viagra) efficacy and safety. Sadovsky, R., Miller, T., Moskowitz, M., et al.[2022]

In 1990, Canada reported 2832 adverse event cases related to vaccines, but with over 12 million vaccine doses administered, the incidence of these events was very low, indicating a strong safety profile for immunizations.

The data collected highlights the effectiveness of the surveillance system in monitoring vaccine safety, reassuring the public about the low risk of adverse events associated with childhood vaccinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events temporally associated with immunizing agents. Duclos, P., Pless, R., Koch, J., et al.[2022]

In a survey of 17 European countries, it was found that while 13 have regulations for reporting adverse vaccine reactions, only six have full-time professionals dedicated to vaccine safety, highlighting a significant gap in resources and expertise.

The study revealed that reporting systems for adverse events following immunization (AEFI) are inconsistent across countries, with many lacking standardized definitions and reporting forms specifically designed for vaccines, which complicates the assessment of vaccine safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccinovigilance in Europe--need for timeliness, standardization and resources. Lankinen, KS., Pastila, S., Kilpi, T., et al.[2015]

The Vaccine Adverse Event Reporting System (VAERS) is a reliable database for assessing vaccine safety, with a good positive predictive value confirmed by multiple studies.

VAERS will play a crucial role in monitoring the safety of new or significantly modified vaccines that are expected to be introduced soon.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the Vaccine Adverse Event Reporting System database. Geier, DA., Geier, MR.[2019]

Between 2004 and 2006, the Netherlands Pharmacovigilance Center Lareb received a total of 914 reports of possible adverse events associated with vaccinations, with most reports coming from health professionals who frequently administered vaccines.

Despite an increase in the proportion of vaccine-related adverse event reports from 1.5% to approximately 6% after 2002, the data did not provide evidence to question the safety of vaccines, indicating that adverse events are relatively rare and difficult to directly link to vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse events following vaccination reported to the Netherlands Pharmacovigilance Center Lareb in 2004-2006]. Labadie, J., van Grootheest, AC.[2008]

Sildenafil citrate is an effective and well-tolerated treatment for erectile dysfunction, evaluated in over 3700 patients across various studies, with a low discontinuation rate due to adverse events (2.5% for sildenafil vs. 2.3% for placebo).

The most common side effects were mild to moderate, including headache (16% for sildenafil), flushing (10%), and dyspepsia (7%), with no serious complications like priapism reported, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical safety of oral sildenafil citrate (VIAGRA) in the treatment of erectile dysfunction. Morales, A., Gingell, C., Collins, M., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Sildenafil citrate: lessons learned from 3 years of clinical experience. [2015]

2. New Zealand pubmed.ncbi.nlm.nih.gov

A risk-benefit assessment of sildenafil in the treatment of erectile dysfunction. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A prospective study of the beneficial effects of dose optimization and customized instructions on patient satisfaction with sildenafil citrate (Viagra) for erectile dysfunction. [2015]

4. England pubmed.ncbi.nlm.nih.gov

What to learn about sildenafil in the treatment of erectile dysfunction from 3-year clinical experience. [2015]

5. India pubmed.ncbi.nlm.nih.gov

Three-year update of sildenafil citrate (Viagra) efficacy and safety. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Inadequate evaluation of potential side effects of sildenafil in preterm stopped Dutch trial. [2021]

7. Canada pubmed.ncbi.nlm.nih.gov

Adverse events temporally associated with immunizing agents. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Vaccinovigilance in Europe--need for timeliness, standardization and resources. [2015]

9. England pubmed.ncbi.nlm.nih.gov

A review of the Vaccine Adverse Event Reporting System database. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

[Adverse events following vaccination reported to the Netherlands Pharmacovigilance Center Lareb in 2004-2006]. [2008]

11. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of sildenafil citrate in the treatment of male erectile dysfunction. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Clinical safety of oral sildenafil citrate (VIAGRA) in the treatment of erectile dysfunction. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Effects of sildenafil (Viagra) administration on seminal parameters and post-ejaculatory refractory time in normal males. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Sildenafil effects on sexual function in asymptomatic volunteers: a controlled study. [2015]