Clinical Trial 46856

Garden Grove, CA 92845


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.

  1. 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.

  2. Patient is fluent in the English language.
  3. Patient is capable of understanding and complying with the protocol and agrees to sign the informed consent document.
  4. 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.
  5. 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.

  6. 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.

    1. 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.
    2. 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.
    3. While latex and polyisoprene condoms are not an acceptable form of contraception, they may be used for the prevention of sexually transmitted infections.
  7. Patient has a body mass index (BMI) from 18 to 35 kg/m2, inclusive.
  8. 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.

  9. Patient is medically healthy with no clinically significant medical history, physical examination, gynecological history and examination, laboratory profiles (e.g., hematology, urinalysis), vital signs (e.g., uncontrolled hypertension), or ECGs, as deemed by the Investigator.

    1. Patients who have clinically significant ECG abnormalities at Visit 1 as confirmed by the Investigator will be excluded.
    2. Patients with controlled, treated hypertension (<140/90 mmHg) on up to two medications (excluding alpha blockers and nitrates) with a stable dose for the past 6 months will be considered eligible.
    3. Patients with controlled, treated thyroid disease on a stable medication and dose for the past 6 months will be considered eligible. TSH must be within normal range (confirmed by laboratory test).
  10. The participant must agree to not use vaginal hormone therapy (e.g., vaginal estrogen, intravaginal prasterone), vaginal or vulvar lubricants, spermicides, creams or gels, contraceptive foams or vaginal douche products throughout the study period.

    1. Women who self-report abnormal physiological vaginal discharge will be excluded until abnormal physiological discharge resolves.
    2. Patients using systemic (transdermal or oral) therapy must be on a stable dose for at least 6 months prior to Visit 1.
  11. Patient must have a total score on the FSDS-DAO >18 through visit 4.

Qualified Participants May Receive:

Monetary compensation for participation. 

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.