Sildenafil Cream for Female Sexual Arousal Disorder

(RESPOND Trial)

Not currently recruiting at 51 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cream form of Sildenafil, a medication commonly used for erectile dysfunction, to assist women with Female Sexual Arousal Disorder. The goal is to determine if this topical cream can reduce side effects and improve sexual arousal by applying it directly to the affected area. Participants will receive either the actual cream or a placebo (a cream with no active ingredient) to compare results. Women who have experienced normal sexual function in the past, have been in a stable relationship for at least six months, and are not currently experiencing major life stress might be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that Sildenafil Cream is likely to be safe for humans?

Previous research has shown that Sildenafil Cream (3.6%) applied to the skin is safe and well-tolerated. Studies found that neither women using the cream nor their partners experienced major side effects. In a large study involving 1,357 sexual interactions, the cream consistently proved safe to use, meaning most people did not encounter serious problems. Overall, the cream has a good safety record for premenopausal women with Female Sexual Arousal Disorder. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Sildenafil cream is unique because it offers a topical delivery method for treating Female Sexual Arousal Disorder, which is different from oral medications typically used for this condition. Unlike existing treatments like oral sildenafil (commonly known as Viagra), this cream is applied directly to the skin, potentially providing more localized and quicker effects with fewer systemic side effects. Researchers are excited about its potential because it targets blood flow directly to the genital area, which might enhance effectiveness and reduce the chance of side effects compared to oral options.

What evidence suggests that Sildenafil Cream might be an effective treatment for Female Sexual Arousal Disorder?

Research has shown that sildenafil cream, which participants in this trial may receive, can help women with Female Sexual Arousal Disorder (FSAD). Studies found that the cream improved outcomes, particularly for women without other orgasm-related issues. The treatment proved effective, safe, and well-tolerated by both users and their partners. This suggests that sildenafil cream could be a promising option for treating FSAD by working directly where needed. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Sildenafil Cream

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 (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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11250102/

Preliminary Efficacy of Topical Sildenafil Cream for the ... Topical sildenafil cream 3.6% improved outcomes among women with female sexual arousal disorder, particularly an exploratory subset of women ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38889431/

Preliminary Efficacy of Topical Sildenafil Cream for the ... Topical sildenafil cream improved outcomes among women with female sexual arousal disorder, most significantly in those who did not have concomitant orgasmic ...

3. academic.oup.com academic.oup.com/jsm/article/21/9/793/7724223

Safety of topical sildenafil cream, 3.6% in a randomized ... These data demonstrate that topically applied sildenafil cream was safe and well tolerated by exposed users and their sexual partners.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04948151?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Dar%C3%A9%20Bioscience,%20Inc.%22)&viewType=Table&rank=1

Multi-Center Study to Evaluate the Efficacy and Safety of ... Evaluating the efficacy of Sildenafil Cream, 3.6% measured by change from baseline to end of study in the number of Satisfactory Sexual Events, question #11 in ...

5. journals.lww.com journals.lww.com/greenjournal/fulltext/2024/08000/preliminary_efficacy_of_topical_sildenafil_cream.4.aspx

Preliminary Efficacy of Topical Sildenafil Cream for the... Topical sildenafil cream 3.6% improved outcomes among women with female sexual arousal disorder, particularly an exploratory subset of women with female sexual ...

6. contemporaryobgyn.net contemporaryobgyn.net/view/phase-2b-safety-data-for-sildenafil-cream-against-fsad-reported

Phase 2b safety data for Sildenafil Cream against FSAD ... In a recent study published in The Journal of Sexual Medicine, Sildenafil Cream, 3.6% was indicated as safe and well-tolerated for use ...

7. urologytimes.com urologytimes.com/view/topical-sildenafil-cream-found-safe-tolerable-in-female-sexual-arousal-disorder

Topical sildenafil cream found safe, tolerable in female ... Topical sildenafil cream (3.6%) was found to be safe and well-tolerated among premenopausal women with female sexual arousal disorder (FSAD) and their sexual ...

8. synapse.patsnap.com synapse.patsnap.com/article/darC3A9-bioscience-publishes-positive-sildenafil-cream-safety-findings-in-the-journal-of-sexual-medicine

Daré Bioscience Publishes Positive Sildenafil Cream ... Topical Sildenafil Cream, 3.6% has been demonstrated to be safe and well-tolerated for use by women and their partners across 1,357 sexual ...

9. cdn.caymanchem.com cdn.caymanchem.com/cdn/msds/10008671m.pdf

Safety Data Sheet Precautions for safe handling. No special precautions are necessary if used correctly. Avoid breathing dust/fume/gas/mist/vapours/spray. Avoid ...