Multi-Center Study to Evaluate the Efficacy and Safety of Sildenafil Cream (3.6%) in Premenopausa… (NCT04948151) | Clinical Trial Compass
UnknownPhase 2
Multi-Center Study to Evaluate the Efficacy and Safety of Sildenafil Cream (3.6%) in Premenopausal Patients With Female Sexual Arousal Disorder
United States440 participantsStarted 2021-06-28
Plain-language 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.
Who can participate
Age range21 Years
SexFEMALE
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Inclusion criteria
✓. Patient must be a premenopausal woman, 21 years or older.
✓. 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.
✓. 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.
What they're measuring
1
SFQ28 (AS) - 28 Day Recall
Timeframe: SFQ28 score at the end of the Single-Blind Placebo Run-In to the end of the 12-Week Double-blind Dosing period.
2
FSDS-DAO (Q14) - 28 Day Recall
Timeframe: Q14 score at the end of the Single-Blind Placebo Run-In to the end of the 12-Week Double-blind Dosing period.
✓. 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.
Exclusion criteria
✕. 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.
✕. 12 months of spontaneous amenorrhea
✕. 6 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.