What will happen in this study?
Women will be randomly assigned to one of four treatment groups. Every participant will receive a cream and a pill. Some women will receive an inactive cream or pill, and only one group will receive both an inactive pill and cream.
If you choose to join this study, you can expect to have 4 visits over 6 months that include:
- Self-insertion of a tampon into the vagina to measure your pain on a scale from 0-10
- A physical exam to measure any pain you are having at pelvic areas (your vulva and vaginal muscles)
- A physical exam to measure any pain you are having at pelvic areas (your vulva and vaginal muscles) and the pain you may have at other body sites (your shoulder, shin and back) and to collect a vaginal swab
- Questionnaires to measure your pain, health, mood and sexual function
- Collection of blood to measure markers of pain and inflammation in your blood stream
There will be about 400 women who participate in this study, about 200 each from UCLA and UNC.