The Penn PCOS Center is conducting a clinical research study to compare the effects of medications on metabolic risk factors such as weight, blood pressure, glucose, and cholesterol levels in overweight/obese women with Polycystic Ovary Syndrome (PCOS) over a sixteen week period. Study participants will be given a four-month supply of the contraceptive vaginal ring, NuvaRing, to use continuously during participation in the study.
Your participation in this study will consist of a screening and enrollment visit, which may or may not occur at the same time, and a completion visit. During this time, you will receive laboratory assessments, questionnaires, medical history collection, medication, and compensation.
Women with a diagnosis of PCOS, between the ages of 18 to 40 years, who are overweight or obese, and not seeking pregnancy may be eligible to participate.
Is this research study something you may be interested in?
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Yes
No
Thank you for taking the time to read about this study. If you are not interested in this study but wish to be updated about other research opportunities, you may fill out the General Interest Screening form on our website at http://whcrc.upenn.edu or add yourself to our email list to receive announcements when new studies begin recruiting.
In order to determine who may be eligible for our research studies, we have created a questionnaire that can be accessed and completed on the Internet.
The advantages to this questionnaire are that:-It can be completed at any time that is convenient for you-You can spend as much time as you like-It can be completed from the privacy of your home-If you are not eligible for our current study, you may be eligible for future studies. If you fill this out your information will be kept on record so that we can contact you in the event that you may be eligible for other studies.
The potential disadvantages are:-The data are transmitted via the internet-The data are stored on a server and contain your name, address and phone.
What is done to minimize these disadvantages:-Transmission is accomplished via encryption technologies like those used by your bank when you bank on-line.-The data you submit is held within a secured network.-The people who may access study records within the University of Pennsylvania include the people working on the study, who is Dr. Roe and her research staff, and representatives from the Penn Office of Clinical Research and the Penn Office of Regulatory Affairs. -The people outside of Penn who may access study records are the study Data and Safety Monitoring Board, the US FDA and the Office of Human Research Protections.
We will do our best to make sure that the personal information we collect from you will be kept private. However, we cannot guarantee total privacy. Your authorization for us to collect and use this information for study screening does not expire.
By providing authorization you are agreeing to be further contacted via email and/or by phone. As with any time email is used the risks includes misdirection to another person and the email may include identifying information as well as information collected in this questionnaire.
You have the option to complete the survey over the phone if you wish. You do so by calling 215-662-7727 and stating you are interested in the RING-PCOS research study.
If you wish to withdraw consent for us to hold your information in our database, you may do so at any time by calling 215-662-7727 and letting us know that you would like to remove your survey information.
These questions will help us determine whether or not you may be eligible to participate in this research study. If any of these questions are questions that you do not wish to answer, you are not required to do so. Completion of this questionnaire is always voluntary.
Do you consent to completing this questionnaire over the Internet?
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Accept
Decline
If you are interested in pre-screening for this study but would prefer to do so over the phone, please call the WHCRC at 215-662-7727 and say that you are interested in the PCOS-Ring study.
First Name:
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Last Name:
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E-mail address:
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Please repeat e-mail address to ensure correct recording:
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The email addresses entered above are not identical, please review.
Phone number:
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Please enter the best phone number, so that we can contact you regarding study participation.
ZIP code:
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How did you find out about this study?
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Penn Website Craigslist Google Facebook Instagram iConnect PCOS Challenge Letter/email Referral by doctor Referral by a study coordinator at Penn Referral by patient On hold phone advertisement TV Other
Where did you find out about this study?:
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What is your age?
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Date of Birth:
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Today M-D-Y
What is your height?
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What is your weight in pounds (approximate)?
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Have you been diagnosed with PCOS (Polycystic Ovary Syndrome)?
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Yes
No
Was your diagnosis of PCOS made by a physician at the University of Pennsylvania?
Yes
No
Do you have excessive body hair growth and/or been evaluated for Hirsutism?
Yes
No
On average, when not on hormonal medications, how many menstrual periods do you have per year?
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Please list the date of your last menstrual period?
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Today M-D-Y
Are you willing to agree to not attempt to conceive during participation in the study?
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Yes
No
Are you pregnant or nursing at this time?
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Yes
No
Are you currently using oral contraceptives, depo progestin, or hormonal implants?
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Yes
No
Do you have any health or medical conditions? If yes, please describe.
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Do you have any personal history or presence of the following:
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Could you please list any medications you currently take, or medications that you have taken in the last 6 months (including birth control and metformin):
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Have you ever had a side effect to birth control pills?
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Yes
No
Are you using a cholesterol lowering or weight loss medication?
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Yes
No
Are you currently participating in a weight loss program such as with exercise, diet or medications?
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Yes
No
Please describe:
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Are you a current or former smoker?
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Yes
No
How much do/did you smoke (number of cigarettes per day)?
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When did you quit smoking
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N/A, currently a smoker
In the last 4 weeks
In the last 3 months
In the last year
2-3 years ago
4 or more years ago
In the past 3 months have you had greater than or equal to 14 drinks/week?
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Yes
No
Have you undergone a bariatric surgery procedure in the past year?
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Yes
No
Have you participated in other research studies in the past month?
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Yes
No
Are you willing to not participate in any other clinical trials during this study?
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Yes
No
Would you like to be contacted about future studies?
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Yes
No