A Open-Label, Within-Subject Dose-Escalation Study to Evaluate the Clinical Safety and Pharmacoki… (NCT02364882) | Clinical Trial Compass
CompletedPhase 1
A Open-Label, Within-Subject Dose-Escalation Study to Evaluate the Clinical Safety and Pharmacokinetic Profile of a Topical Sildenafil Cream (5% w/w), in Healthy Postmenopausal Women
United States21 participantsStarted 2015-01
Plain-language summary
This is a Phase 1, single center, open-label, within-subject dose-escalation study evaluating the safety and pharmacokinetics of SST-6006 in healthy postmenopausal women. Three dose levels of SST-6006 and a placebo regimen will be evaluated: 1 g (0 mg of sildenafil), 1 g (50 mg of sildenafil), 2 g (100 mg of sildenafil), and 4 g (200 mg of sildenafil). Doses will be administered sequentially and will be separated by a 14-16 day washout period. All 3 dose levels and the placebo will be applied both externally and internally.
Who can participate
Age range
35 Years – 65 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
. Subject must be postmenopausal (surgically induced or natural) between the ages of 35 and 65 years, inclusive, verified by 1 of the following:
. Subject must have a serum follicle-stimulating hormone (FSH) lab result \> 40mIU/mL.
. Subject has a body mass index (BMI) from 18 to 33 kg/m², inclusive.
. Subject has a normal electrocardiogram at baseline.
. Subject has had a Pap smear performed within one year prior to the Screening visit and can provide documentation indicating normal test results.
. Subject is in good health for age, as determined by medical and Ob-Gyn history and physical and gynecological examinations.
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.
. Subject is a non-smoker (no tobacco use within 6 months) and agrees not to smoke for the duration of the study up until completion of the last Treatment Period.
. Subject is capable of understanding and complying with the protocol and agrees to sign the informed consent document.
Exclusion criteria
. Subject has any disorder or a history of any disorder that may prevent the successful completion of the study in the opinion of the PI.
. 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, or confound the interpretation of study results in the opinion of the PI.
. Subject has a history of sexual or physical abuse.
. Subject had an active ulcer or clinically significant bleeding disorder.
. Subject has a history of myocardial infarction, stroke, or life-threatening arrhythmia within 6 months prior to Day 1; or any history of coronary disease causing angina; or congestive heart failure requiring medical intervention.
. 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 a history of orthostatic hypotension or orthostatic hypotension which is present at the Screening visit, 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.