Phase 2a Topical Sildenafil Proof-of-Concept Study in Men With Mild to Moderate ED

NCT02390960 | Completed Phase 2

• 1 other identifier: SST-6006-007-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

Brief Summary

This is a Phase 2a, single-dose, double-blind, placebo-controlled, 2-way crossover study in men with ED. A single 2 gram dose of SST-6006 topical cream 5% w/w (formulated to deliver 100 mg of sildenafil) or a topical placebo cream will be applied to the penile shaft and glans. There are 4 study phases: the Initial Patient Screening Phase (Visit 1, an Off Site 4-Week Run-in Period and Visit 2), the Final Patient Screening Phase (Visit 3), the SST-6006/Placebo Double-Blind Dosing Phase (Visits 4-5), and the Follow-up Phase. Primary outcomes will be be evaluated at Weeks 7 and 8 of the study

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Cumulative duration of ≥ 60% rigidity at the base of the penis during 60 minutes of VSS (SST-6006 compared to placebo cream)

  60 minutes

Secondary Outcomes (2)

• Percentage of patients reporting occurrence of at least one Grade 3 or Grade 4 erection as defined by the EHS (refer to Appendix B) (SST-6006 compared to placebo cream)

  60 minutes

• Adverse Events

  From first application of cream (Week 5) through follow-up phone call (Week 9)

Study Arms (2)

Sildenafil

ACTIVE COMPARATOR

Sildenafil (SST-6006) is a preserved, white to off-white, topical cream. The active ingredient is 5% sildenafil citrate by weight. During the SST-6006 dosing period, penile plethysmography will be utilized to evaluate efficacy of SST-6006 verses placebo cream. The plethysmography session will be approximately 75 minutes. This includes a 15 minute 'baseline' period where patients are told to remain in the flaccid state and 60 minutes during which time patients will watch a series of erotic videos.

Drug: Sildenafil Cream; Device: Penile Plethysmography (RigiScan)

Placebo

PLACEBO COMPARATOR

Placebo cream will be the same as SST-6006 without the active ingredient, sildenafil citrate. It will be matched in appearance, smell, consistency, and color to SST-6006 topical sildenafil cream. During the placebo cream dosing period, penile plethysmography will be utilized to evaluate efficacy of SST-6006 verses placebo cream. The plethysmography session will be approximately 75 minutes. This includes a 15 minute 'baseline' period where patients are told to remain in the flaccid state and 60 minutes during which time patients will watch a series of erotic videos.

Drug: Placebo Cream; Device: Penile Plethysmography (RigiScan)

Interventions

Sildenafil Cream DRUG

Patients will be instructed to apply pre-weighed SST-6006 to the non-erect penile skin area at the time of dosing. Patients will then massage the cream into the penile shaft and glans for a maximum of 3 minutes.

Also known as: SST-6006

Sildenafil

Placebo Cream DRUG

Patients will be instructed to apply the pre-weighed placebo cream to the non-erect penile skin area at the time of dosing. Patients will then massage the cream into the penile shaft and glans for a maximum of 3 minutes.

Placebo

Penile Plethysmography (RigiScan) DEVICE

During each dosing period, penile plethysmography will be utilized to evaluate efficacy of SST-6006 verses placebo cream. Each plethysmography session will be approximately 75 minutes.This includes a 15 minute 'baseline' period where patients are told to remain in the flaccid state and 60 minutes during which time patients will watch a series of erotic videos.

Placebo; Sildenafil

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is a heterosexual male ≥ 18 and ≤ 70 years of age.
• Patient has had a clinical diagnosis of erectile dysfunction for a minimum of 6 months.
• Patient has a body mass index (BMI) from 18 to 30 kg/m², inclusive.
• \. Patient is capable of understanding and complying with the protocol and agrees to sign the informed consent document.
• Patient agrees to use condoms with sexual activity for 7 days immediately following each visit that involves application of SST-6006 or placebo cream (i.e. Visit 2, Visit 4 and Visit 5).
• \. Patient has a testosterone level ≥ 300 ng/dL (either naturally or through androgen replacement therapy; if on androgen replacement therapy, must have been taking for ≥ 6 months).
• \. Patient is willing to undergo plethysmography procedure with VSS during the trial

You may not qualify if:

• Subject is unfamiliar with or unwilling to watch visual sexual stimulation (VSS).
• \. Subject has any disorder or a history of any disorder that may prevent the successful completion of the study.
• \. Subjects with an abnormal physical exam, that in the opinion of the Investigator, would interfere with study participation.
• \. Subject has a significant cardiovascular, hepatic, 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, contraindicate sexual activity, or confound the interpretation of study results.
• \. Subject has an active ulcer or clinically significant bleeding disorder. 6. Subject has a history of myocardial infarction, stroke, or life-threatening arrhythmia within 6 months prior to Visit 1; a history of coronary disease causing angina; or congestive heart failure requiring medical intervention.
• \. Subject has uncontrolled hypertension or untreated hypertension. 8. Subject has a history of orthostatic hypotension or orthostatic hypotension.
• \. Subject is unable to walk up and down two flights of stairs briskly without chest pain.
• \. Subject is using alpha blockers. 11. Subject is using or has possession of nitrate containing medication(s). 12. Subject has retinitis pigmentosa or sickle cell anemia or related anemias, even if the subject feels clinically well at the time of screening. Subjects 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 subjects 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.
• \. Subject has anatomical deformation of the penis such as angulation, cavernosal fibrosis, or Peyronie¡-s disease, or history of genital surgery.
• \. Subject has a history of prostate surgery. 15. Subject has a history of pelvic radiation. 16. Subject has type 1 or type 2 diabetes. 17. Subject has a history of cancer other than basal cell carcinoma. 18. Subject has any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article.
• \. Subject has a history of drug abuse within 1 year before Visit 1. 20. Subject has a history of alcoholism within 1 year before Visit 1, admitted alcohol abuse, or has an average consumption of more than 2 standard units of alcohol per day (a standard unit equals 12 ounces of beer, 1¨ö ounces of 80-proof alcohol, or 6 ounces of wine).
• \. Subject has had treatment currently or within 1 month (28 days) of Visit 1 with any of the following: weak, moderate, and strong inhibitors and inducers of CYP3A4 and CYP2C9 enzymes (e.g., CYP3A4: ketoconazole, clarithromycin, verapamil, diltiazem, St. John¡-s Wort / CYP2C9: fluconazole, oxandrolone, fluvastatin, and metronidazole). Any prescription, over-the-counter (OTC) medications, or herbal products taken recently or currently being taken will be screened by study personnel prior to study enrollment to confirm such drugs do not inhibit or induce the two enzymes listed above. If the subject takes any prescription or OTC drugs at the direction of a health care provider that are inhibitors or inducers of CYP3A4 and CYP2C9, that provider should be consulted before medications are stopped for the purposes of study participation.
• \. Subject is unwilling to refrain from using any medication for erectile dysfunction, with the exception of study medication, after Visit 1 and throughout the duration of the study up until the completion of Visit 5.
• \. Subject has positive findings from urine drug screen (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, and opiates).
• \. Subjects with a positive alcohol breath test. 25. Subject participated in any clinical research study evaluating another investigational drug or therapy within 30 days before the Visit 1.

Sponsors & Collaborators

• Strategic Science & Technologies, LLC: lead

Study Sites (3)

San Diego Sexual Medicine

San Diego, California, 92120, United States

Location

Tulane Medical Center

New Orleans, Louisiana, 70112, United States

Location

Manhattan Medical Research

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Eric Fossel, PhD

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 18, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 12, 2017

Record last verified: 2017-10

Locations

US (3)