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

NCT04948151 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: SST-6006-013
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 51

Brief Summary

This study is looking to minimize side effects, while maintaining and potentially improving the therapeutic benefit to patients suffering from Female Sexual Arousal Disorder by providing a topical preparation of Sildenafil locally to the vulvar-vaginal tissue.

Conditions

Female Sexual Arousal Disorder

Keywords

Sexual Disorder; Arousal Disorder; FSAD

Outcome Measures

Primary Outcomes (2)

• SFQ28 (AS) - 28 Day Recall

  Evaluating the efficacy of Sildenafil Cream, 3.6% measured by change from baseline to end of study in the Arousal-Sensation Domain of the SFQ28.

  SFQ28 score at the end of the Single-Blind Placebo Run-In to the end of the 12-Week Double-blind Dosing period.

• FSDS-DAO (Q14) - 28 Day Recall

  Evaluating the efficacy of Sildenafil Cream, 3.6% measured by change from baseline to end of study in the score for feeling concerned by difficulties with sexual arousal - Item #14 only of the FSDS-DAO.

  Q14 score at the end of the Single-Blind Placebo Run-In to the end of the 12-Week Double-blind Dosing period.

Secondary Outcomes (1)

• Arousal Diary (SSE)

  measured by daily prompt within 24hrs after each sexual event during the Single-Blind Placebo Run-In compared to the last 4 weeks of the Double-Blind Dosing Period.

Study Arms (2)

Sildenafil Cream, 3.6%

EXPERIMENTAL

Drug: Sildenafil

Placebo Cream

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Sildenafil DRUG

Patients will apply 2-gram applications up to 9 times per month.

Sildenafil Cream, 3.6%

Placebo DRUG

Patients will apply 2-gram applications up to 9 times per month

Placebo Cream

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be a premenopausal woman, 21 years or older.
• a. Transgender individuals assigned a female gender at birth will be permitted to enroll provided they are not currently undergoing hormone treatment, have not undergone gender reassignment surgery and do not intend to for the duration of the study.
• Patient is fluent in the English language.
• Patient is capable of understanding and complying with the protocol and agrees to sign the informed consent document.
• Patient has been in a stable, monogamous, relationship that was secure and communicative, for at least 6 months prior to Visit 1. The relationship is with one sexual partner, who is sexually functional, both psychologically and physically. The partner will be consistent and available throughout the duration of the study.
• Based on the clinical interview, in their past, patient had experienced 'normal' sexual function for at least 2 years or longer. Patient has had sexual activity at least two times each month during the last 6 months and agrees to have sexual activity at least two times each month for the duration of the study). Sexual activity can include any activity which may result in sexual stimulation or sexual pleasure e.g., intercourse, caressing, foreplay, masturbation, and oral sex.
• a. Patients who have experienced a recent major life stress (e.g., loss of income, death of a family member) or relationship discord that could interfere with sexual activity (except distress related to FSAD) will be excluded.
• Women of childbearing potential must agree to continue using an acceptable form of birth control during the study and agree to continue to stay on their dose of birth control throughout the duration of the study. Birth control is not required for confirmed same sex couples, couples with confirmed vasectomy or couples with confirmed tubal ligation.
• Acceptable forms of birth control include the following: intrauterine system \[IUS\], progestin and/or estrogen-containing hormonal oral contraceptives, contraceptive patch, contraceptive implant, contraceptive injection, or the copper-containing intrauterine device (IUD). Patients must be using the progestin and or estrogen-containing hormonal oral contraceptives or contraceptive patch for least 6 months prior to Visit 1 without clinically significant complications in the opinion of the Investigator. Patients must be using the IUS, IUD, contraceptive implant, or contraceptive injection for at least 3 months prior to Visit 1 without clinically significant complications in the opinion of the Investigator.
• Vaginal forms of contraception such as contraceptive foams/gels, diaphragms, penile or vaginal condoms, contraceptive vaginal rings, and are not considered acceptable methods of birth control in this study.
• While latex and polyisoprene condoms are not an acceptable form of contraception, they may be used for the prevention of sexually transmitted infections.
• Patient has a body mass index (BMI) from 18 to 35 kg/m2, inclusive.
• Patient has had a Pap smear performed within three years prior to Visit 1 and can provide documentation indicating normal test results (based on current guidelines as published by the U.S. Preventive Services Task Force).
• a. If the patient cannot provide documentation, a Pap smear will be performed at Visit 1.
• Patients with abnormal findings will be excluded from study participation and be referred for follow-up medical care as appropriate.

You may not qualify if:

• Patient is nursing or pregnant (based on positive serum pregnancy test), wishes to become pregnant or begin nursing during the study period or was pregnant or nursing within 6 months prior to Visit 1.
• Patient has more than one sexual partner.
• Patient is postmenopausal (surgically induced or natural) meeting any of the following criteria:
• Bilateral oophorectomy.
• months of spontaneous amenorrhea
• months of spontaneous amenorrhea with serum FSH levels \>40mIU/mL (except for those women on hormone replacement therapy)
• Patient has any disorder or a history of any disorder that may prevent the successful completion of the study in the opinion of the Investigator.
• Patient has a significant cardiovascular, hepatic, metabolic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, genitourinary, 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.
• Patient has a history of unresolved sexual trauma or abuse that is contributing to any sexual dysfunction problem (desire, arousal, orgasm, etc.) as determined by the clinical interview.
• Patient with any history of active peptic ulcers or clinically significant bleeding disorders.
• Patient with a history of clitoral priapism or conditions which may predispose them to clitoral priapism (such as sickle cell anemia, multiple myeloma, or leukemia).
• Patients with a history of myocardial infarction, stroke, or life-threatening arrhythmia within 6 months prior to Visit 1; patients with resting hypotension (BP \<90/50 mmHg); or any history of coronary disease causing angina; or congestive heart failure requiring medical intervention; patients with underlying conditions which can be particularly sensitive to the actions of vasodilators including patients with left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) and patients with impaired autonomic control of blood pressure, or for those for which sexual activity is inadvisable due to their underlying cardiovascular status.
• Patient with a history of hearing loss (unless born completely deaf).
• Patient has retinitis pigmentosa, even if the patient feels clinically well at the time of Visit 1. Patients 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 patients 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.
• Patient 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, an increase in pulse by 20 beats per minute or experiencing lightheadedness or dizziness at 1 or 3 minutes after the change in position from supine to standing.

Sponsors & Collaborators

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

Study Sites (51)

Coastal Clinical Research

Mobile, Alabama, 36608, United States

RECRUITING

Precision Clinical Trials-Arizona

Phoenix, Arizona, 85032, United States

RECRUITING

Visions Clinical Research -Tucson

Tucson, Arizona, 85712, United States

RECRUITING

Collaborative Neuroscience Network

Garden Grove, California, 92845, United States

RECRUITING

NRC Research Institute

Orange, California, 92868, United States

RECRUITING

Medical Center for Clinical Research - San Diego

San Diego, California, 92108, United States

RECRUITING

Schuster Medical Research Institute

Sherman Oaks, California, 91403, United States

RECRUITING

Downtown Women's Healthcare

Denver, Colorado, 80209, United States

RECRUITING

Coastal Connecticut Research, LLC

New London, Connecticut, 06320, United States

RECRUITING

Intimmedicine Specialists

Washington D.C., District of Columbia, 20036, United States

RECRUITING

South Florida Medical Research

Aventura, Florida, 33180, United States

RECRUITING

AMR Fort Myers

Fort Myers, Florida, 33912, United States

RECRUITING

Clinical Neuroscience Solutions-Orlando

Jacksonville, Florida, 32256, United States

RECRUITING

New Age Medical Research Corporation

Miami, Florida, 33186, United States

RECRUITING

Suncoast Clinical Research - Pasco County

New Port Richey, Florida, 34652, United States

RECRUITING

Healthcare Clinical Data, Inc.

North Miami, Florida, 33161, United States

RECRUITING

CNS Healthcare

Orlando, Florida, 32801, United States

RECRUITING

Comprehensive Clinical Research, LLC

West Palm Beach, Florida, 33409, United States

RECRUITING

AGILE Clinical Research Trials

Atlanta, Georgia, 30342, United States

RECRUITING

iResearch Atlanta

Decatur, Georgia, 30030, United States

RECRUITING

Rosemark Women Care Specialists

Idaho Falls, Idaho, 83404, United States

RECRUITING

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

RECRUITING

Cypress Medical Research Center

Wichita, Kansas, 67226, United States

RECRUITING

Southern Institute for Women's Sexual Health

Covington, Louisiana, 70433, United States

RECRUITING

Praetorian Pharmaceutical Research

Marrero, Louisiana, 70072, United States

RECRUITING

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

RECRUITING

Women's OB-GYN, P.C. dba Saginaw Valley Medical

Saginaw, Michigan, 48604, United States

RECRUITING

Quality Clinical Research

Omaha, Nebraska, 68114, United States

RECRUITING

Omaha OB GYN Associates, P.C.

Omaha, Nebraska, 68130, United States

RECRUITING

Essential Women's Health Associates

Las Vegas, Nevada, 89113, United States

RECRUITING

Office of Doctor Rex G. Mabey Junior

Las Vegas, Nevada, 89128, United States

RECRUITING

Women's Health Research Center

Lawrenceville, New Jersey, 086489, United States

RECRUITING

New Jersey Urology - Bloomfield

Millburn, New Jersey, 07041, United States

RECRUITING

The Center for Specialized Women's Health

Morristown, New Jersey, 07960, United States

RECRUITING

Suffolk Obstetrics and Gynecology

Port Jefferson, New York, 11777, United States

RECRUITING

Velocity Clinical Research - Cleveland (Rapid Medical Research)

Cleveland, Ohio, 44122, United States

RECRUITING

Aventiv Research, inc.

Columbus, Ohio, 43214, United States

RECRUITING

University Hospitals Landerbrook

Mayfield Heights, Ohio, 44124, United States

RECRUITING

Rivus Wellness & Research Institute

Oklahoma City, Oklahoma, 73112, United States

RECRUITING

Velocity Clinical Research, Providence

Warwick, Rhode Island, 02886, United States

RECRUITING

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

RECRUITING

ClinSearch

Chattanooga, Tennessee, 37421, United States

RECRUITING

Clinical Neuroscience Solutions - Memphis

Memphis, Tennessee, 38119, United States

RECRUITING

Medical Research Center of Memphis

Memphis, Tennessee, 38120, United States

RECRUITING

Urology Associates - Nashville

Nashville, Tennessee, 37209, United States

RECRUITING

TMC Life Research

Houston, Texas, 77054, United States

RECRUITING

Maximos Obstetrics and Gynecology

League City, Texas, 77573, United States

RECRUITING

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

RECRUITING

Health Research of Hampton Roads, Inc.

Newport News, Virginia, 23606, United States

RECRUITING

Tidewater Clinical Research

Norfolk, Virginia, 23502, United States

RECRUITING

Seattle Women's Health Research - Gynecology

Seattle, Washington, 98105, United States

RECRUITING

Related Publications (2)

• Johnson I, Thurman AR, Cornell KA, Symonds T, Hatheway J, Friend DR, Goldstein A. Comparisons and correlations of 1-month recall vs 24-hour recall in patient-reported outcomes of an exploratory, phase 2b, randomized, double-blind, placebo-controlled clinical trial of sildenafil cream, 3.6% for the treatment of female sexual arousal disorder. J Sex Med. 2024 Sep 3;21(9):787-792. doi: 10.1093/jsxmed/qdae086.

  PMID: 39059373 DERIVED

• Johnson I, Thurman AR, Cornell KA, Hatheway J, Dart C, Brainard CP, Friend DR, Goldstein A. Preliminary Efficacy of Topical Sildenafil Cream for the Treatment of Female Sexual Arousal Disorder: A Randomized Controlled Trial. Obstet Gynecol. 2024 Aug 1;144(2):144-152. doi: 10.1097/AOG.0000000000005648. Epub 2024 Jun 18.

  PMID: 38889431 DERIVED

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

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

Central Study Contacts

Kathy Cornell

CONTACT

774-473-4414; kcornell@strategicscience.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 1, 2021
• Study Start: June 28, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: July 1, 2021

Record last verified: 2021-06

Locations

US (51)