Using Thermography to Assess the Affects of Sildenafil Cream, 3.6%

NCT05765487 | Completed Phase 1 FDA Drug

• 1 other identifier: SST-6006-015
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare thermography images in normal healthy premenopausal women after the application of Sildenafil Cream, 3.6%, L-arginine cream, and placebo cream. Participants will be shown a series of explicit videos to elicit a change in genital temperature before and after application of cream.

Conditions

Sexual Arousal Disorder

Outcome Measures

Primary Outcomes (1)

• Evaluate the difference in vulvar blood flow after the use of investigational products

  To evaluate and compare the impact of 2 grams of Sildenafil Cream 3.6%, Placebo Cream and Vehicle Cream on vulvar blood flow, as assessed by thermography in normal healthy premenopausal women.

  14 days

Study Arms (3)

Sildenafil Cream, 3.6%

ACTIVE COMPARATOR

Contains both Sildenafil and L-arginine

Drug: Sildenafil

Placebo Cream

PLACEBO COMPARATOR

Contains L-arginine, no Sildenafil

Drug: Placebo

Vehicle Cream

OTHER

Contains no L-arginine, no Sildenafil

Drug: Vehicle

Interventions

Sildenafil DRUG

Sildenafil Cream, 3.6%

Sildenafil Cream, 3.6%

Vehicle DRUG

No Active or experimental ingredients

Vehicle Cream

Placebo DRUG

Cream with only L-arginine

Placebo Cream

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be a premenopausal woman at least 18 years of age.
• Subject must be willing to avoid high protein meals and follow dietary guidance provided by the study site staff for the duration of the study.
• Women of childbearing potential must be using an acceptable form of birth control (i.e., intrauterine system \[IUS\], progestin and/or estrogen-containing hormonal contraceptives, contraceptive patch, contraceptive implant, contraceptive ring, or contraceptive injection) or the copper-containing intrauterine device (IUD) and must be on a stable dose or have had the insert/implant for at least 1 month without complication prior to Visit 1 and agree to continue to stay on their birth control for the duration of the study. Condoms (latex or polyisoprene only) are not considered an acceptable form of birth control but may be used to prevent exposure to sexually transmitted infections. An attempt will be made to enroll at least 30% of women who are using hormonal contraception and at least 30% who are not.
• Subject reports she has viewed heterosexual pornography prior to Visit 1 and is sexually aroused from watching heterosexual porn or sexually explicit videos depicting men and women engaging in sexual activity.
• Subject has a body mass index (BMI) \< 38 kg/m². Subjects with a BMI \>30 kg/m2will be visually evaluated to ensure that there will not be physical interference with viewing the areas of interest by the thermography camera. If the investigator deems that interference is likely due to BMI, the subject will be excluded.
• Subject has a normal electrocardiogram at Visit 1.
• Subject is capable of understanding and complying with the protocol and agrees to sign the informed consent document.
• Subject has been sexually active (in the past 4 weeks since Visit 1). Sexual activity can include caressing, foreplay, masturbation, and vaginal intercourse.
• Subject is fluent in the English language.
• Subject is willing to trim pubic hair (if necessary) to allow for accurate genital temperature readings and visualization of the genital regions of interest.
• Subject has had a Pap smear performed within three years prior to Visit 1 and can provide documentation indicating results that are either normal or atypical squamous cells of undetermined significance (ASCUS) but negative for Human Papilloma Virus (HPV) (based on current guidelines as published by the U.S. Prevention Services Task Force). If the subject cannot provide documentation, a Pap smear will be performed at Visit 1. Subjects with abnormal findings will be excluded from study participation and be referred for follow-up medical care as appropriate.
• Subject is in good health for age, as determined by physical and gynecological history and examination at Visit 1.
• Subject agrees to withhold from smoking tobacco products 24 hours prior to all visits.
• Subject agrees to use compatible condoms (latex or polyisoprene) if she chooses to engage in vaginal or anal intercourse with her partner and abstain from receptive oral sex throughout the Double-Blind Dosing Phase and for seven days following the completion of Visit 4 to avoid potential partner exposure to the IP and to help prevent the transmission of sexually transmitted infections. Condoms should be used concurrently with subject's acceptable contraceptive method.
• Subjects must agree to not use vaginal or vulvar lubricants, spermicides, creams or gels, contraceptive foams, or vaginal douche products from Visit 1 until after the follow-up safety call is completed 7±3 days after Visit 4.

You may not qualify if:

• Subject is nursing or pregnant (based on positive urine pregnancy test) or wishes to become pregnant during the study period.
• Subject has any disorder or a history of any disorder that may prevent the successful completion of the study in the opinion of the Investigator.
• Subject has used any topical hormone replacement therapy (HRT) applied locally to the genitals in within three months of Visit 1.
• Subject has a significant cardiovascular, hepatic, metabolic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, genitourinary, or psychiatric disease or other unstable medical condition that would contraindicate administration of study medication, interfere with study evaluation, limit study participation, or confound the interpretation of study results in the opinion of the Investigator.
• Subjects with controlled, treated thyroid disease on a stable medication for the past 6 months will be considered eligible. Thyroid Stimulating Hormone (TSH) must be within normal range (confirmed by laboratory test).
• Subjects with controlled, treated hypertension on a stable dose of ACE Inhibitors or Angiotensin II Receptor Blockers for the past 6 months will be considered eligible.
• Subject had an active ulcer or clinically significant bleeding disorder.
• Subject is actively menstruating at Visit 1 or has reported abnormal spotting in the 3 months preceding Visit 1.
• Subject has a history of myocardial infarction, stroke, or life-threatening arrhythmia within 6 months prior to Visit 1; or any history of coronary disease-causing angina; or congestive heart failure requiring medical intervention.
• Subject has retinitis pigmentosa or sickle cell anemia or related anemias, even if the subject feels clinically well at the time of Visit 1. Subjects with retinitis pigmentosa will be identified by specifically asking whether they have the condition, if there are visual signs and symptoms of the condition (including questioning subjects as to whether they have difficulty seeing at night or in low light, and if they have any visual field deficits that indicate a loss of peripheral or central vision), or if there is a family history.
• Subject has a history of orthostatic hypotension or orthostatic hypotension which is present at Visit 1, defined as a drop in systolic blood pressure ≥ 20 mm Hg, a drop in diastolic blood pressure ≥ 10 mm Hg or experiencing lightheadedness or dizziness at 1 or 3 minutes after the change in position from supine to standing.
• Subject reports a history of sexual dysfunction (e.g., anorgasmia, vaginismus, hypoactive sexual desire disorder, arousal difficulties etc.).
• Patient has dyspareunia, vulvovaginal infection or inflammation, inflammatory disorders of the vulva or vagina, vestibulodynia, clitorodynia, Genitourinary Syndrome of Menopause (GSM) or vulvovaginal atrophy.
• Subject has insulin dependent type 1 or type 2 diabetes.
• Subjects who do not demonstrate a greater positive slope for genital temperature change over time during the Sexually Explicit Video Session as compared to the Neutral Video Session during the 'no-cream' familiarization session at Visit 1 will not be eligible to advance into the Double-Blind Dosing Phase of the study. Any positive slope (i.e., any genital temperature increase, slope\>0) during the sexually explicit file viewed in Visit 1 is considered qualifying for subjects to proceed into the double-blind dosing phase.

Sponsors & Collaborators

• Daré Bioscience, Inc.: lead
• Strategic Science & Technologies, LLC: collaborator

Study Sites (1)

Pharma Medica Research, Inc.

Mississauga, Ontario, Canada

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 13, 2023
• Study Start: May 13, 2023
• Primary Completion: January 26, 2024
• Study Completion: October 21, 2024
• Last Updated: September 4, 2025

Record last verified: 2025-09

Locations

CA (1)