Frequently Asked Questions

Is this study only for females with CT and GC?


Yes, this study is focused on females with CT and GC. If you are a male and would like to participate in any future studies for males, feel free to contact us to let us know that you are interested in future studies.




What if I am not sure about my CT or GC diagnosis?


It would be best for you to see your doctor for a clear CT or GC diagnosis. If there is a diagnosis, ask your doctor for a copy of your diagnosis. The documentation will help our study team proceed with the potential enrollment process.




What if I am already getting treatment for my CT or GC diagnosis would I still qualify?


If you are getting the standard of care treatment for CT or GC we will ask that you continue your treatment as directed. You will be eligible to enroll 14 days after the last treatment of your medication.




How long will the study last?


The study will take approximately 20 weeks to complete.




What does a typical visit consist of?


If you meet all the criteria for the study, you will complete an intial visit, which will consist of the consenting of the study (which explains the purpose of this research study, procedures, benefits, risks, and precautions), a test for current GC/CT infection by NAAT (vaginal swab), and the dispensing of study product. Visits will occur ever 4 weeks (5 visits total), during these visits we will ask you to complete a urine pregnancy test, review your electronic diary, document the unused and used product, and dispense you the new product.




Do I have to pay to participate in the Sensitive Study?


There is no charge for taking part in this research study. All study-related exams, visits to the study center, procedures, and medications related to the research study will be covered.




Will I be paid for taking part and/or reimbursed for travel?


If you pre-qualify and are referred to a nearby research site, the study staff can discuss compensation that may be available.




What is a clinical Trial?


A clinical research study, also known as a clinical trial, is conducted to evaluate the safety and effectiveness of an investigational medication compared to standard care or placebo. If the medication is proven to be safe and effective during a clinical research program, the US Food and Drug Administration (FDA) may approve it for prescription use. In addition to studying the effectiveness and safety of medications, a research study may also help advance knowledge about specific health-related issues, such as endometriosis pain. It takes a team of healthcare professionals to conduct a research study. Besides the primary doctor who oversees this research study, the research team may include other doctors, physician assistants, nurses, medical assistants and other healthcare professionals. It is only through the completion of research studies that investigational medications can be evaluated and, if proven safe and effective, may be approved for use by the FDA. All prescription medications in use today were first proven safe and effective in clinical research studies. For more information about clinical research studies in general, visit https://clinicaltrials.gov/ct2/about-studies.




What is an investigational study medication?


‘Investigational medication’ means that the medication is being tested through a clinical research study. In this study the investigational medication is testing the efficacy of the medication Amphora Gel to see if there is a reduction risk of CT or GC.




Who oversees my clinical research information?


To help ensure that a clinical research study is ethical and that participants’ rights are protected, Institutional Review Boards (IRB) or Ethics Committees (EC) review and approve study protocols.




Who can I talk to about this research study?


Call 409-867-5309 if you have any questions. Our staff will be available to answer any of the questions you may have about the Sensitive Study.




Will I know if I will be on the investigational medication or placebo while I am in the study?


This is a blinded study, which means that this study is done in such a way that the participant does not know (is blinded as to) what treatment they are receiving to elimate or reduce biases until the trial outcome is known.





CAPE COD SCAVENGER HUNTS

508-244-5222

Cape Cod Scavenger Hunts | 2019

Book Now