The Penn State Health Research Center is conducting a clinical trial 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 six-month period. Study participants will be randomized to one of three groups: 1) Birth Control Pills (to improve male hormone levels), 2) Metformin (to improve insulin levels) or 3) both Birth Control Pills and Metformin.
Your participation in this study will consist of a screening visit, followed by 5 study visits (2 long all day visits and 3 short visits). During this time, you will receive physical exams, laboratory assessments, ultrasound, bone density scans, lifestyle and nutritional advice, medications, 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?
* must provide value
Yes
No
Thank you for taking the time to read about this study.
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 Penn State Health include the people working on the study, who is Dr. Legro and his research staff, and representatives from the Penn State Office of Clinical Research and the Penn State Office of Regulatory Affairs.
-The people outside of Penn who may access study records are representatives of the sponsors of this study, The National Institutes of Health, our collaborators at the University of Pennsylvania, 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 717- 531-3692 and stating you are interested in the COMET-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 717- 531-3692 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?
* must provide value
Accept
Decline
If you are interested in pre-screening for this study but would prefer to do so over the phone, please call Penn State Health Research Center at 717-531-3692 and say that you are interested in the PCOS study.
First Name:
* must provide value
Last Name:
* must provide value
E-mail address:
* must provide value
Please repeat e-mail address to ensure correct recording:
* must provide value
The email addresses entered above are not identical, please review.
Phone number:
* must provide value
Please enter the best phone number, so that we can contact you regarding study participation.
ZIP code:
* must provide value
How did you find out about this study?
* must provide value
StudyFinder Craigslist Google Facebook Instagram Radio PCOS Challenge Letter/email Referral by doctor Referral by a study coordinator at PSU Referral by patient On hold phone advertisement TV Other
Where did you find out about this study?:
* must provide value
What is your age?
* must provide value
Date of Birth:
* must provide value
Today M-D-Y
What is your height?
* must provide value
What is your weight (approximate)?
* must provide value
Have you been diagnosed with PCOS (Polycystic Ovary Syndrome)?
* must provide value
Yes
No
On average, when not on hormonal medications, how many menstrual periods do you have per year?
* must provide value
Please list the date of your last menstrual period?
* must provide value
Today M-D-Y
Participation in the study requires that you are not at risk for pregnancy. This means that to participate women must: agree to use a form of non-hormonal contraception (Condom or Occlusive cap), have a sexual partner who was vasectomized, have a hysterectomy or tubal ligation, or practice total abstinence from sexual intercourse. Are you willing to agree to this?
* must provide value
Yes
No
Please note your planned method of contraception
* must provide value
condom occlusive cap had a hysterectomy or tubal ligation partner was vasectomized abstinence other
What form of contraception?
* must provide value
Are you willing to agree to not attempt to conceive during participation in the study?
* must provide value
Yes
No
Are you pregnant or nursing at this time?
* must provide value
Yes
No
Are you currently using oral contraceptives, depo progestin, or hormonal implants?
* must provide value
Yes
No
Do you have any health or medical conditions? If yes, please describe.
* must provide value
if so, please list
Do you have any personal history or presence of the
following:
* must provide value
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):
* must provide value
Have you ever had a side effect to birth control pills?
* must provide value
Yes
No
Have you ever had a side effect to Metformin?
* must provide value
Yes
No
Are you using a cholesterol lowering or weight loss medications?
* must provide value
Yes
No
Are you currently participating in a weight loss program such as with exercise, diet or medications?
* must provide value
Yes
No
Please describe:
* must provide value
Are you a current or former smoker?
* must provide value
Yes
No
How much do/did you smoke (number of cigarettes per day)?
* must provide value
When did you quit smoking
* must provide value
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?
* must provide value
Yes
No
Have you undergone a bariatric surgery procedure in the past year?
* must provide value
Yes
No
Have you participated in other research studies in the past month?
* must provide value
Yes
No
In the past 12 months, have you participated in other research studies that included exposure to ionized radiation?
* must provide value
Yes
No
Are you willing to not participate in any other clinical trials during this study?
* must provide value
Yes
No
Would you like to be contacted about future studies?
* must provide value
Yes
No