CoSMIC II Study

STUDY BASICS

Are you a healthy woman between 18-45 years old? You may be able to participate in a research study to build a model to help develop new medicines. Compensation is provided.

STUDY PURPOSE

The purpose of this research study is to collect specimens and data that researchers will use to help build a model showing how medicines that are placed in the vagina, cervix, or uterus are processed by the body. Some examples of these medicines are vaginal rings for birth control or HIV prevention and intrauterine devices (IUDs). In the future, having this kind of model could help researchers to develop generic forms of medications, which are much less expensive for everyone. We plan to perform pelvic ultrasounds and to obtain vaginal, cervical, and endometrial biopsies from healthy women to help develop this model. 

COULD THIS STUDY BE RIGHT FOR YOU?

Eligible participants are:

• 18-45 years old 
• Willing to have vaginal fluid samples collected and undergo genital biopsies and/or a pelvic ultrasound 
• Using condoms, sterilization, the combination pill, or patch as birth control 

WHAT PARTICIPANTS CAN EXPECT

Study participation will involve one to two visits at Magee-Womens Hospital.  At the first visit, we will perform a urine pregnancy test, collect a vaginal fluid sample, and determine your eligibility to participate in the study. If you are eligible to participate based on these screening procedures, you may choose to undergo at least one of the following optional procedures at your visit:  vaginal biopsy, cervical biopsy, endometrial biopsy, or pelvic ultrasound. You may choose to undergo all of the procedures.  Depending on the timing of the ultrasound scheduling, you may have all of these procedures in one study visit or you may need to return for a second visit for the pelvic ultrasound. If this happens, you will need to wait at least 7 days after the biopsies before having an ultrasound performed to allow the biopsy sites time to heal.   Also, if you choose to undergo biopsies, study staff will call you at least 7 days after your biopsies to be sure that you are continuing to do well after your visit.  You can take ibuprofen or acetaminophen prior to the biopsies to reduce discomfort.