What Happens in this Study?
Women will be randomized (like drawing numbers from a hat) to one of the following treatment groups:
Group 1: Lidocaine/estrogen combination vaginal cream (peripheral treatment) and a placebo pill (like a sugar pill with no medicine in it)
Group 2: Placebo vaginal cream (a plain cream without any medicine in it) and nortriptyline (an oral pill used to treat nerve-related pain)
Group 3: Combined peripheral lidocaine/estrogen combination vaginal cream) and nortriptyline
Group 4: Placebo vaginal cream and placebo oral pill
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) 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
How many participants are enrolled?
About 400 women will take part in this study, about 200 women from our UCLA and UNC site.