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 range

21 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

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.

Trial details

NCT IDNCT04948151

SponsorStrategic Science & Technologies, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-12-15

Contact for this trial

Kathy Cornell

774-473-4414 kcornell@strategicscience.com

View on ClinicalTrials.gov More Female Sexual Arousal Disorder trials

Who can participate

Age range

21 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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.

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.

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria