Join us to try a new naturopathic treatment for yeast infections
Apply NowIt is estimated that 75% of women will experience a yeast infection, and 34% suffer from multiple infections every year.1
Every woman deserves fast relief from the pain and itching associated with yeast infections. Now there is a non-pharmaceutical treatment that works with cooling temperatures to reduce your symptoms fast and effectively to clinically treat vaginal yeast and bacterial infections.
This treatment was invented by a woman OB/GYN, for women.
Coologics wants to work with you to bring quick relief to women diagnosed with a yeast infection. If you’re between the ages of 21 and 50, are not pregnant and are not diagnosed with diabetes, you may be eligible for our clinical study! Participating in this study is a step toward ensuring women will have a non-pharmaceutical option for treating yeast infections.
Apply Now
To determine if you are eligible to join the study, we need to ask you a few questions. In just a few minutes you can find out if you are eligible to join. This questionnaire will help us better understand you and your body and determine if this study is right for you.
Why join this study?
By participating, you’ll play a vital role in creating a change in women’s healthcare by helping to study this innovative approach to treating vaginal infections. Conducting studies is the way products are refined and approved to be offered to the American public.
Participating in this study is a step in ensuring women will have a non-pharmaceutical option for treating yeast infections. Additionally, you will receive:
● 6 applications of the study device at no cost
● Up to $150 in compensation for your time
● In-clinic medical care and testing at study visits with doctors or nurses who are trained in women’s health
● Easy-to-use app for recording your daily journal
How do I participate?
Participation is easy. It involves a twice daily treatment for three days. Plus, three in-person visits (initial visit, plus two check-in visits) at a medical office with a trained medical doctor or nurse who specializes in women’s health to provide you with the best possible care.
All visits will include a physical exam, medical testing and medical care. You will also check in once daily for 28 days in an app on your smart phone or tablet. The app check in will take approximately 5 minutes and can be done from anywhere with a signal to your device.
There is no charge to you for these visits, the products, the testing or the care you will receive. Our team of professionals will be available to answer your questions throughout the study.
- FILL OUT THIS FORM
Click Apply Now and complete the form. If you are eligible, you will receive immediate notification and an email with instructions to schedule your first appointment. - MEET WITH THE DOCTOR
The doctor or nurse will verify your eligibility, and you will receive testing, study products and instructions for the study, including how to use the study app. - BEGIN THE 28-DAY STUDY IMMEDIATELY
You may begin using the study treatment the same day. Then record your experience in the app daily and return for two checkup visits (one in 7 days and one in 28 days). Your appointments will be scheduled today.
If you have any questions, please contact the study team at vr@validcare.com.
Find out if you are eligible to join the study.
It only takes a few minutes to find out if you are eligible to join. These quick questions will help us to determine if this study is right for you.
How Does The Study Work?
Complete the pre-screening questionnaire
If you are eligible, you will receive immediate notification and an email with instructions to schedule your first appointment.
Receive the medical devices at the medical office
Attend your initial appointment and, if eligible, you’ll receive the vaginal cooling devices from the doctor or nurse then.
Conduct the treatment
During the 28-day study period, you will insert the vaginal cooling device twice daily for three days and allow it to remain for 30 minutes while you are sitting or lying down.
Record your experience for 28 days
Each day, you’ll provide insight on your experience by answering a short series of questions in the study app. We want to know how you’re feeling, how this condition is impacting your life, your level of pain or discomfort, and how things are improving.
FAQs (Frequently Asked Questions)
For answers to additional questions, please check the below FAQ. If the information you need is not there, get in touch with us at vr@validcare.com.
About Our Study
This study is testing the efficacy and safety of a new naturopathic treatment for yeast infections, invented by a woman OB/GYN for women, that utilizes cooling temperatures instead of pharmaceuticals.
Coologics is conducting this study to support its application with the FDA to offer this treatment to women in the United States. Participating in this study is a step toward ensuring women will have a non-pharmaceutical option for treating yeast infections.
Click Apply Now to complete the pre-screening questionnaire and see if you qualify to participate. If you and your baby qualify, you will receive an email confirming eligibility. The email contains instructions to schedule your first visit with the doctor to finalize enrollment.
This study is sponsored by Coologics in partnership with Validcare, a leader in clinical scientific research. The study complies with the Food and Drug Administration (FDA) and Institutional Review Board (IRB) regulations for clinical best practice. Our study is all about providing you with the best experience and professional care. If you would like to learn more about our team, feel free to visit validcare.com or contact us at vr@validcare.com and we will be happy to answer your questions.
About Your Participation
The study takes 28 days, including enrollment and visits. Once you have registered, you will be asked to visit a study doctor for physical exams three times – once on the first day, once after 7 days, and once after 28 days. You will also answer daily questions in a study app on your phone or tablet so we can understand how you’re feeling, how this condition is impacting your life, your level of pain or discomfort, and how things are improving.
The total monetary compensation for completing the study is $150, spread out over three payments. You will also receive the following at no cost:
- 6 applications of the study product
- In-clinic medical care and testing at study visits with doctors or nurses who are trained in women’s health
- An easy-to-use study app for recording progress and accessing FAQs
Payments are made to you when study milestones are achieved. After you successfully complete each visit, you will receive a payment. After the first visit, you will receive $25. After the second visit, you will receive $25. After the final visit, you will receive $100. Each payment is made as an electronic Visa gift card.
You may qualify for this study if you:
- Suspect you have a yeast infection
- Are a woman between 21-50 years of age, and it has been less than one year since your last menses
- Do not have diabetes
- Are willing and able to avoid vaginal sexual activity during the entire 28-day study
Note: Menstrual products such as tampons, pads, and menstrual cups may be used during the 28-day study.
Yes, you must be willing and able to avoid all vaginal sexual activity during the entire 28-day study.
Note: You may use menstrual products such as tampons, pads, and menstrual cups during the 28-day study.
Yes, you may use menstrual products such as tampons, pads, and menstrual cups during the 28-day study.
No, the study must only be done with women who are not pregnant.
Please do not apply for this study if you:
- Suspect you have a yeast infection
- Are a woman between 21-50 years of age, and it has been less than one year since your last menses
- Do not have diabetes
- Are willing and able to avoid vaginal sexual activity during the entire 28-day study
Yes, you will be asked to disclose the following daily in the study app:
- Any OTC or prescription medications
- Any dietary, nutritional or vitamin/mineral supplements
- Any natural, botanical, or homeopathic remedy
- Any cream, lotion, or other material applied directly to the vulva or vagina to relive symptoms
About the Vaginal Cooling Device
The vaginal cooling device is similar in shape and size to an applicator-less tampon. It is approximately 3 inches long and 1inch in diameter and designed by a female OB/GYN to fit comfortably within a woman’s vagina. It is rounded on both ends and has a built-in removal loop at one end to easily grasp and remove the device.
Each device is individually wrapped and must be placed in the freezer for 2 hours before beginning use so that the gel inside the sealed device becomes frozen. The outer casing is not as cold as the inner gel and creates a smooth and comfortable surface for easy vaginal insertion, similar to inserting a tampon.
For the study, you’ll sit or lie down for 30 minutes with the device inserted in your vagina. In that time, the vaginal cooling device and the gel inside of it will warm to your body temperature. All gel remains inside the cooling device.
You will be asked to record your symptoms prior to and immediately following the use of the device.
Each device is in an individually wrapped package and must be placed in the freezer for 2 hours before beginning use so that the gel inside the sealed device becomes frozen.
After freezing, take one package from the freezer and remove the device from the package. Run cool tap water over the device for 5 seconds. Insert the device into your vagina (similar to inserting a tampon) but with the loop remaining outside your body. Sit or lie down for 30 minutes.
After 30 minutes, grasp the removal loop of the vaginal cooling device, gently remove it and discard the device.
You will do this twice per day for the first three days of the study.
The vaginal cooling device is designed to be easily inserted and to allow a comfortable level of cooling to the vaginal walls. If you are experiencing challenges, please contact the doctor or nurse who is conducting your in-person visits.
In medical emergencies, please contact your own physician.
Once you register for the study and are approved to participate, you will receive the six disposable vaginal cooling devices at your first visit with the doctor or nurse. You will also receive instructions at your first visit on how to insert and remove the device. During the study, you will complete six treatments with the cooling device. Each device will be used once and then disposed.
My Responsibilities
No, please do not share information about the study on social media. This is a private medical health study. Sharing information publicly means you are sharing private health information about yourself.
Yes, female friends who are experiencing a yeast infection can apply to join the study, if they meet the qualifications. Direct them to this page on our website to apply.
If you have any concerns about not being able to complete the full 28 days of the study, please do not apply. However, if you do participate in the study and need to discontinue and leave the study for any reason, please contact the study doctor or nurse immediately to let them know about your change. They will need to collect information from you to close out your study participation.
About Coologics
The sponsor of this study is Coologics – a clinical stage medical device company founded by a board-certified female OB/GYN with 19 years of experience who was also a frequent sufferer of yeast infections. She designed a non-pharmaceutical way to treat vaginal infections fast and effectively that is also safe and easy to use.
Yes, a previous human study had positive results for ease of use, degree of cooling, and efficacy with no reported complications or adverse effects. This study is approved by the Institutional Review Board (IRB) and listed on clinicaltrials.gov.
This study meets the requirements of the Food and Drug Administration (FDA) is approved by an Institutional Review Board (IRB).
The devices are made in the USA and the company is seeking FDA approval to make them available to women in the USA.
Coologics
1468 W. 9th Street, Suite 100
Cleveland, OH 44113
