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Author Archive

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

 

Doing Our Part!

Tuesday, April 21st, 2020

It’s been quite a month here in Southeastern Connecticut as we work together to flatten the curve against COVID-19.  Please allow us to thank our many study volunteers to continue to participate in research.  We would also like to thank the doctors, nurses, pharmacists, first responders, grocery store workers, and all those staffing essential businesses who are on the front lines of the Coronavirus pandemic. We also offer our deepest condolences to those families who have lost a loved one as a result of COVID-19.

Research is underway throughout the world trying to create an effective vaccine for the disease. Now more than ever, we shine a light on how important research is to improving our world.

It seems that many of us are living day to day, doing our best to comply with social distancing and keep others safe and healthy.  Spring in New England is typically a time we witness blossoming beauty all around us.  Here is hoping our world can heal and we can all do our part to stay safe, healthy and keep others safe and healthy.

 

How Are You Doing?

Tuesday, April 7th, 2020

How are you doing?  We sincerely hope you and your loved ones are in good health.  A few months ago who knew the term “social distancing” would become such a part of our everyday lives?  We appreciate all of our study volunteers who have continued to participate in research (with the proper safety measure and protocols in place.)  We also are proud to work in the important field of research. Many Americans who were once unfamiliar with the term “clinical trial” are beginning to hear more about how important it is to find new ways of treating disease, illness and chronic conditions.

While life as we once knew it may be temporarily on hold, there are many things you can do to continue to enjoy your quality of life.  Journal.  Keep a gratitude list. Go out for a walk each day (keeping proper social distance of course!)  Gaze up at a clear blue sky. Play with your dog.  Hug your kids.  Place a zoom call with some old friends.  Play scrabble.  Sit down for a meal with your family.  Smile. Breathe deeply.  Meditate. You get the picture.

We are still screening patients for our hot flash study and are pre-screening patients over the telephone for studies including migraines and work productivity, Parkinson’s disease, birth control and Alzheimer’s disease.  If you wish to learn more, contact us, we’re here – (860)443-4567.

Stay well!

March 24, 2020 Coronavirus Statement

Tuesday, March 24th, 2020

Coastal Connecticut Research is part of the healthcare services and pharmaceutical industries, considered critical infrastructures by our government. As such, we will remain open to provide care and to monitor our clinical research study patients.

Because social distancing has been identified as a key component in preventing the spread of the Coronavirus, we have moved the screening visits of potential study participants to a later date and will only be seeing patients already enrolled in current studies.

For those who may have been interested in one of our studies, please keep in mind all of our prescreening is done over the telephone by site personnel. Potential study participants can prescreen at any time over the telephone, with appointments being set up at a later date.

Coastal Connecticut Research will continue to follow the appropriate hygienic and social distancing procedures implemented at our site as a result of the Coronavirus.

Please contact Coastal Connecticut Research at (860)443-4567 if you have any further questions.  We look forward to continuing to serve you by providing quality study-related care, a professional atmosphere and all the latest updates to how we are responding to the Coronavirus situation.

Dr. Robert M. Spitz

Medical Director

Coastal Connecticut Research

What We Do is Essential!

Monday, March 23rd, 2020

We are proud to let you know what we do at Coastal Connecticut Research is considered essential by our state and federal government.  Providing exceptional study-related care to our patients, monitoring their health while they participate in a study, and educating potential participants about future studies and the importance of research is part of our daily operations.

We understand these are difficult times for our nation and for individuals as each of us responds to the Coronavirus crisis in different ways.  While we cannot control what is happening around us, we can control our reaction to what is happening around us and respond appropriately.  Some of you may be working from home, some of you who at a higher risk may be remaining at home, and all of us are urged to practice social distancing.  We have appropriate procedures in place to assure the health and safety of our study participants at this time in accordance to regulations being set forth.

So, if you are feeling anxious or cooped up, maybe it’s time to get out in the backyard, go for that long walk you could not get to during your regular 8-hour day, or even better, reconnect with an old friend through email or the telephone.  We can assure you when life returns to “normal,” we will still continue to be here for you.  In addition, if you are interested in a study, please know you can participate in a prescreening questionnaire over the telephone by calling (860)443-4567.  We are proud of the work we do and thankful for our study volunteers!

Coronavirus Statement – March 16, 2020

Monday, March 16th, 2020

At Coastal Connecticut Research our goal is to keep our study patients safe and healthy.  With the current concerns in place over social distancing and the Coronavirus, please keep in mind patient health and safety has always been our top priority.  In order to address national and global concerns in halting the spread of the Coronavirus, we will do the following:

  • We will continue to clean and sanitize all office and medical equipment prior to and following each patient visit
  • We will be limiting the number of patients we see during the course of the day as our country as a whole responds to requests for social distancing by the CDC.
  • We will assess the overall condition of our study patients upon each visit to our site by monitoring vital signs and general health while continuing to follow the protocol for each of our research studies.
  • With this in mind, please consider our request to you. If you are scheduled for an office visit, we ask you call us the day before to assess your current condition.  Study patients who are scheduled and may be displaying signs of any fever, respiratory infection or possible virus please contact our site prior to your visit to reschedule in order to ensure the health and safety of our research team and study participants.

Please contact Coastal Connecticut Research at (860)443-4567 if you have any further questions.  We look forward to continue to provide the highest quality study-related care to our patients.

Dr. Robert M. Spitz

Medical Director

Coastal Connecticut Research