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Author Archive

A Hot Flash Story

Wednesday, September 16th, 2020

Have hot flashes impacted your multi-tasking?

Once upon a time there was a lady who had been through menopause suffering with hot flashes.  She had to throw the covers off her at night due to such profuse sweating and during the day, constantly fanned herself to stay cool. One day, the woman heard a radio commercial about a clinical research study enrolling in New London evaluating a product for women with hot flashes.  She called the site, answered some questions over the phone, and learned she qualified for the study. But alas, the lady was hesitant to participate. She was a bit uneasy about trying something that was not yet available for prescription.  She said she had to think about it, and so she did.  The lady told one of the members of the CCRstudies team at the research site she was a bit uneasy. After learning more about the study product and the design of the study, she felt better informed. She even learned one of the products she took everyday had been evaluated in the past at the very same sight!  The lady had never thought twice about taking this product and realized people like her must have participated in a clinical trial in order for the medication to gain FDA approval. This changed her way of thinking – she decided she too wanted to help others.  It was no longer just about her hot flashes, but rather, she gained a greater understanding of the importance of being a research volunteer.  The lady had already found her prince years ago, she wasn’t very concerned about that sort of happy ending. What made more of a difference to her was the fact she could ultimately impact someone else’s life by participating in a clinical trial.

Why Volunteer?

Wednesday, September 2nd, 2020

You’re a busy person. We get it. There is an old saying which goes something like this, “if you want to get something done, just ask a busy person.”  We are truly appreciative of all those individuals who come forward to participate in research. It is a form of service to others who someday may benefit from the study product you are evaluating.  Volunteers in our research studies come from all walks of life – nurses, engineers, stay-at-home parents, retail workers, students, teachers, retirees, scientists, home-health aides, municipal employees, the list goes on.  What these individuals have in common is a desire to help others by participating in research.

Today as we as a nation deal with a “new normal” due to the Covid-19 pandemic, we want to assure those participating in research and those interested in research, that we are operating in accordance with CDC guidelines and precautions in regards to keeping you and our team safe.  The health and safety of all those in our studies was always of paramount concern and with heightened protocols, it is still our greatest focus.  So, thank you for putting your trust in us.  We will work extremely hard to continue to do our very best.

If you are interested in learning more about the clinical research process and how you might get involved, reach out!  We offer no-contact prescreening over the telephone for our currently enrolling studies and are happy to speak with you candidly regarding the research process.  Call (860)443-4567 or text the keyword CCR to 74121. You can also sign up for a study online here on our website  – just click and apply!  E-mail your questions to marylou@ccrstudies.com.  We look forward to hearing from you and sharing information!

Dog Days of Summer – and Then Some!

Monday, August 10th, 2020

Did you think your back to school shopping for your student (whether this be preschool or college) would include face masks?  We are five months into an altered way of life here in Eastern Connecticut.  Thankfully, our state has been working hard to combat the pandemic our fellow global citizens have been faced with.

Please know we here at Coastal Connecticut Research put patient safety first.  We have worked extremely hard to provide an environment suitable for the utmost quality study-related care. We also greatly appreciate our valued study volunteers who are the heart and soul of the clinical research trials we conduct.

We understand some people are extremely uneasy about venturing out during this times. If you have any concerns or questions regarding study participation, feel free to call us at (860)443-4567.  We’d love to get the conversation started with you and address any questions you may have.

Our region has so much to offer, especially in the summer.  We hope during these socially distant times you are still able to connect with what is important to you – whether this be a day at the beach or on the water, a walk in one of our lovely parks, or a conversation with a good friend.  As we are told to keep six feet away, sometimes our connections have to take on a new look.

Wishing you good health and happiness as the dog days of summer roll along!

Summer Heat and Hot Flashes

Tuesday, July 21st, 2020

This summer looks a little different than past years.  Did you ever think you would be walking on the beach with a mask on?  Or, did you ever think you wouldn’t be able to actually get on the beach due to limited capacity?  We are completely on board with social distancing and flattening the curve! We get it!   One thing about summer remains the same – heat and humidity!  For women suffering with hot flashes, there seems to be no relief.

Coastal Connecticut Research is currently involved with hot flash research.  Postmenopausal women who have been living with hot flashes and night sweats have been coming forward to participate in a study evaluating an investigational medication for the condition.  The study is continuing to enroll qualified local women who may be experiencing these symptoms and who have an interest in participating in research.  We thank all volunteers! Some women have referred to hot flashes as “their own personal summer.”  We understand your personal summer can be a big bummer, even more so when it’s 95 and humid!

People who wish to learn more about research are encouraged to contact us.  We are happy to share information with you.  E-mail marylou@ccrstudies.com, text the keyword CCR to 74121 and we’ll call you back, or simply give us a ring at (860)443-4567.  We look forward to connecting!

Birth Control Research

Thursday, July 9th, 2020

A recent decision by the United States Supreme Court is expected to make obtaining access to affordable birth control by prescription considerably more difficult for some women whose employers do not wish to cover those services.  Under the Affordable Care Act, women were supposed to be granted access to no cost contraception.  Unfortunately, many women who wish to engage in responsible family planning are not always able to afford a monthly prescription to a birth control pill or other contraceptive product.

Clinical research is underway in New London evaluating an investigational, oral birth control product.  Not everyone is aware there is no cost to participate in a clinical research trial and no cost for the study product.  All labs, exams and testing are available at no cost.  Women will also receive the birth control study product for one year at no cost.  Reimbursement may also be available for time and travel.

Some choose to participate in research because they like the feeling of helping others.  Some choose to participate in research because their health care options are limited, they are uninsured or under-insured, and they appreciate the no-cost study related healthcare.  Decisions to participate in research are personal, but the impact of volunteering creates a ripple effect in regards to helping to advance medicine.

If you wish to learn more about clinical healthcare research studies in New London, call to speak to a member of the CCRstudies team at (860)443-4567. You can also email marylou@ccrstudies.com or text the keyword CCR to 74121.

Birth Control Study

Wednesday, June 17th, 2020

 

Did you know at one time in our history animal dung was used as barrier contraception?  Did you also know in our history here in the United States up until the 1960’s it was illegal for a woman to use contraception?  We’ve come a long way.

While a variety of contraceptive products are available for a woman’s reproductive health, researchers continue to explore options for those in their reproductive years who do not wish to conceive, or who are looking to help control the sometimes painful and uncomfortable symptoms of menses.

Coastal Connecticut Research is currently conducting a clinical trial evaluating an investigational birth control product. The study is enrolling eligible women ages 18-45 years old.  Dr. Robert M. Spitz is the study gynecologist.  There is no cost to participate in the study and no cost for the investigational birth control pill which will be used by participants for one year.  Reimbursement is available to time and travel. Those wishing to learn more can text the keyword CCR to 74121 or call (860)443-4567. Email marylou@ccrstudies.com  if you have further questions. The CCRstudies team is always happy to speak with you to educate you regarding our clinical research trials and the important role of the study volunteer.

Birth Control Product Gains FDA Approval

Monday, June 1st, 2020

Exciting news!  A birth control product for use “in-the-moment,” evaluated by study participants at Coastal Connecticut Research, has gained FDA approval.  Thank you to our volunteers for participating in this women’s healthcare research study.

U.S. FDA Approves Evofem Biosciences

Phexxi TM (lactic acid, citric acid and potassium bitartrate),
the First and Only Non-Hormonal Prescription Gel for the Prevention of Pregnancy
A New Class of Female-Controlled Birth Control for Use In-The-Moment

SAN DIEGO, May 22, 2020 — Evofem Biosciences, Inc. (NASDAQ: EVFM) today announced that the U.S.
Food and Drug Administration (FDA) has approved Phexxi  TM (lactic acid, citric acid and potassium
bitartrate) vaginal gel for the prevention of pregnancy in females of reproductive potential for use as an
on-demand method of contraception.

Phexxi is the first non-hormonal, on-demand, vaginal pH regulator contraceptive designed to maintain
vaginal pH within the normal range of 3.5 to 4.5 an acidic environment that is inhospitable to sperm.
There have been a limited number of advances in birth control over the last two decades.

As the first vaginal pH regulator with a unique mechanism of action, the Company is working to have
Phexxi covered under the Affordable Care Act (ACA). The ACA mandates that private health plans provide
coverage with no out-of-pocket costs for one treatment per class in each of the classes identified by the
FDA for women in its Birth Control Guide.

Evofem is committed to ensuring access to Phexxi for all women seeking non-hormonal contraception,
including for women who are not covered by government or private health plans, and will provide a
financial assistance program to enable access for eligible women.

Covid-19 PEP Study

Saturday, May 9th, 2020

A groundbreaking effort seeking volunteers from states including Connecticut is being announced. The PEP (post-exposure prophylaxis) Study is seeking to evaluate the effectiveness of a treatment for people exposed to Covid-19. Scientists are seeking a preventative treatment.

COVID-19 PEP Study

Celebrating Nurses!

Thursday, May 7th, 2020

It’s National Nurses Week!  Where would we be without our nurses?  Thank you Diane Palmer, RN and Kelley Sanok, RN, for providing the highest quality care to all of our study patients.  Thank you for all of the behind-the-scenes work you do in the very detailed and involved field of clinical research.  You ladies are rock stars!  And, a special thank you to all those on the front lines during the Covid-19 pandemic.  Your selflessness is amazing.  Thank you!

 

 

 

Keeping Our Patients Safe and Healthy

Thursday, May 7th, 2020

Thank you for your continued participation in research during these unprecedented times.

In order to continue to operate safely, we request you inform our site if you have been in contact recently with someone who has tested positive for COVID-19. This could be a family member you live with, a colleague at work, or someone you may care for.

As you are aware our site has a variety of measures and protocols in place in order to comply with social distancing initiatives and to keep our patients and staff safe and healthy.

We appreciate your support in this endeavor and thank you for being a dedicated research volunteer.

You are welcome to call us at (860)443-4567.

Thank you again for your cooperation and participation.

Dr. Robert M. Spitz

Medical Director

Coastal Connecticut Research