Study to Evaluate the Efficacy and Safety of SST-6007, a Topical Sildenafil Cream, Compared to Placebo in Women With Female Sexual Arousal Disorder

NCT02570282 | Completed Phase 2

• 1 other identifier: SST-6007-02-01
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 2, single center, single-dose, double-blind, placebo-controlled, 2-way crossover study to evaluate the safety and efficacy of SST-6007 in women with FSAD. A sufficient number of participants will be enrolled to yield 30 (approximately 15 pre-menopausal and 15 post-menopausal) participants to complete the SST-6007/Placebo Double-Blind, Dosing Phase of the study (Visit 2 and Visit 3).

Conditions

Sexual Arousal Disorder

Keywords

Female

Outcome Measures

Primary Outcomes (2)

• Participant-reported levels of subjective sexual arousal measured continuously by the Arousometer

  Measured on a 1-7 numeric scale evey 2 seconds

  1 hour

• Physiological genital response in women with FSAD assessed using the vaginal photoplethysmograph (VPP)

  Measured on a 1-10 scale by electrical impulse 6 times a second

  1 hour

Secondary Outcomes (1)

• Adverse events and vital signs

  21 days

Study Arms (2)

Sildenafil

EXPERIMENTAL

SST-6007 is a white to off-white cream containing 5% (w/w) sildenafil citrate

Drug: SST-6007

Placebo

PLACEBO COMPARATOR

Placebo IP will be the same as SST-6007 without the active ingredient, sildenafil citrate. It will be matched in appearance, smell, consistency, and color to SST-6007

Drug: Placebo

Interventions

Placebo DRUG

Approximately 50% of the cream is to be applied externally to the clitoris and labia minora and approximately 50% is to be applied intravaginally.

Placebo

SST-6007 DRUG

SST-6007 is a white to off-white cream containing 5% (w/w) sildenafil citrate

Sildenafil

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Post-menopausal women (surgically induced or natural) must meet 1 of the following criteria:
• Surgical oophorectomy, partial hysterectomy, or full hysterectomy at least 1 year prior to screening (self-report).
• No spontaneous menses \>1 year (self-report).
• Post-menopausal participants, who are not on any hormone replacement therapies (HRT), must have a serum follicle-stimulating hormone (FSH) lab result \>40mIU/mL.
• Women of childbearing potential must agree to continue using an appropriate form of birth control from Visit 1 through 7 days following the completion of Visit 3. Acceptable forms of birth control include the use of an IUD or hormonal therapy (oral, patch, etc.). Contraceptive foams/gels or condoms are not considered acceptable methods of birth control in this study. Participants must be on a stable dose for at least 6 months prior to Visit 1.
• Participant has a body mass index (BMI) from 18 to 30 kg/m², inclusive.
• Participant is heterosexual.
• Participant has a normal electrocardiogram at Visit 1.
• Participant is capable of understanding and complying with the protocol and agrees to sign the informed consent document.
• Participant must agree to not use vaginal or vulvar lubricants, spermicides, creams or gels, contraceptive foams or vaginal douche products from Visit 1 until the completion of Visit 3 9 Participant agrees to not engage in strenuous, unaccustomed exercise within 6 hours of visit 2 or visit 3.

You may not qualify if:

• Participant is nursing or pregnant (based on positive serum pregnancy test), or wishes to become pregnant during the study period.
• Participant has any disorder or a history of any disorder that may prevent the successful completion of the study in the opinion of the Sub-Investigator.
• Participant has used any topical hormone replacement therapy (HRT) applied locally to the genitals in the past three months. Oral and patch form of HRT are acceptable, as long as the participant reports being on a stable dose for at least 6 months prior to Visit 1.
• Participant 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 Sub-Investigator.
• Participant had an active ulcer or clinically significant bleeding disorder.
• Participant 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.
• Participant has retinitis pigmentosa or sickle cell anemia or related anemias, even if the participant feels clinically well at the time of Visit 1. Participants 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 participants 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.
• Participant 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.
• \. Participant has primary anorgasmia, vaginismus, or sexual aversion disorder.
• \. Participant has dyspareunia.
• \. Participant has type 1 or type 2 diabetes.
• \. Participant has undergone major pelvic surgery that may have caused nerve damage, including, vulvectomy, colostomy, cystostomy, or serious bladder, rectal, or abdominal surgery; neurological impairment due to diabetes, stroke, pelvic nerve damage secondary to trauma, cancer treatments, myasthenia gravis, multiple sclerosis or spinal cord damage.
• \. Participant has current and/or previous reported diagnoses of DSM-IV-TR axis I disorders including organic mental syndromes and disorders (e.g., schizophrenia, bipolar disorder, depression).
• \. Participant has a history of cancer, other than basal cell carcinoma.
• \. Participant has any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article in the opinion of the Sub-Investigator.

Sponsors & Collaborators

• Strategic Science & Technologies, LLC: lead

Study Sites (1)

The Sexual Psychophysiology Laboratory

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Cindy Meston, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: October 3, 2015
• First Posted: October 7, 2015
• Study Start: September 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 3, 2017

Record last verified: 2017-01

Locations

US (1)