Single-Dose Relative Bioavailability Study of SST-6006, a Topical Sildenafil Cream Versus Oral Sildenafil in Healthy Male Adults

January 23, 2014 updated by: Strategic Science & Technologies, LLC
The purpose of this study is to evaluate how a single dose of sildenafil cream (SST-6006) is absorbed and eliminated by the body, with and without the use of a condom, compared to a single oral sildenafil dose and to evaluate the safety of sildenafil cream.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States
        • SST Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Willing and able to sign and date the written informed consent form (ICF) before any study-specific screening procedures are performed
  2. Men between the ages of 18 to 55 years, inclusive
  3. Body mass index (BMI = weight [kg]/height [m]2) between 18.0 to 30.0 kg/m2, inclusive and body weight of at least 50 kg
  4. Nonsmoker or past smoker who has been abstinent for 6 months before study Day 1
  5. Have a high probability for compliance with and completion of the study, in the opinion of the Principal Investigator
  6. Healthy as determined by the investigator based on medical history, physical examination, clinical laboratory tests, vital sign measurements, and a normal 12-lead ECG
  7. Resting supine systolic blood pressure between 90 and 140 mmHg and resting supine diastolic blood pressure between 50 and 90 mmHg
  8. Must be able to achieve a successful erection

Exclusion Criteria:

  1. Presence or history of any disorder that may prevent the successful completion of the study
  2. Presence of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, genitourinary, or psychiatric disease, or other unstable medical condition
  3. Subjects with a history of myocardial infarction, stroke, or life-threatening arrhythmia within 6 months prior to study Day 1, or a history of coronary disease causing angina
  4. Subjects with retinitis pigmentosa and subjects with sickle cell anemia or related anemias, even if they feel 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
  5. Subjects with anatomical deformations of the penis such as angulation, cavernosal fibrosis or Peyronie's disease
  6. History of orthostatic hypotension or orthostatic hypotension present at the screening visit, defined as a drop in systolic blood pressure greater than 20 mm Hg and a drop in diastolic blood pressure greater than 10 mm Hg with a change in position from supine to standing
  7. A history of erectile dysfunction or a prostatectomy
  8. Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article
  9. Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study Day 1
  10. History of drug abuse within 1 year before study Day 1
  11. History of alcoholism within 1 year before study Day 1, admitted alcohol abuse, or average consumption of more than 2 standard units of alcohol per day (a standard unit equals 12 ounces of beer, 1½ ounces of 80-proof alcohol, or 6 ounces of wine)
  12. Use of any prescription drugs within 28 days before study Day 1, or over-the-counter drugs, including herbal supplements (except for the occasional use of acetaminophen [Tylenol] and vitamins) within 14 days before study Day 1. If the subject takes any prescription or OTC drugs at the direction of a health care provider, that provider should be consulted before medications are stopped for the purposes of study participation.
  13. Positive serologic findings for human immunodeficiency virus antibodies (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (HCV)
  14. Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, and opiates) or alcohol screen
  15. Participation in a clinical trial within 30 days before study Day 1
  16. Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or soda) or alcoholic beverages within 48 hours before study Day 1
  17. Consumption of grapefruit or grapefruit-containing products within 72 hours before study Day 1
  18. Any skin breaks, irritation, or lesions present in the area to which the cream will be applied, assessed at screening and check-in
  19. A drug or food allergy which in the opinion of the Investigator contraindicates participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 5% Sildenafil Cream (SST-6006)
5% Sildenafil Cream
Drug: 5% Sildenafil Cream (SST-6006)
5 % Sildenafil Cream
Active Comparator: Oral Sildenafil 50 mg
Drug: Oral Sildenafil 50 mg
Oral Sildenafil 50 mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Cmax, Tmax, AUC 0-tlast, AUC 0-t, Kel, AUC0-inf, t1/2, CL/F
Time Frame: 32 hours
32 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 7 to 10 days
Number of subjects experiencing TEAEs.
7 to 10 days
Clinical Chemistry Tests
Time Frame: 1 day
Changes from baseline in clinical chemistry values
1 day
Vital Signs
Time Frame: 1 day
Vital sign changes from pre-dose
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Strategic Science & Technologies, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SST-6006-001-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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