About

About Our Study

Our goal is to learn about controlling pain and effective treatments for women with VBD.

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.

Study Type

In order to learn about controlling pain and effective treatments for women with VBD, our study is designed as a Randomized placebo-controlled blinded clinical trial (RCT). This type of study allows us to remove as much bias as possible from the study process.

In RCTs, we want to see if a specific treatment actually makes a positive difference to the people getting it. To figure out if it does, we need to compare if the women taking a drug or treatment do better than those who receive a placebo (a sugar pill).

Blinding means that neither you nor the researchers know what you’re getting. This allows the researchers to measure the physical effects of the treatment independently of your and the researcher’s expectations and beliefs about the value of the treatment. We also do it this way because sometimes people can have response to a placebo (called the placebo effect). This response can be positive or negative. So, it’s important that neither you nor the researchers know what group you’re in.

Sponsors, Funders, and Approvals

This study is funded by a grant from the National Institutes of Health, National Institute of Child Health and Development (R01 HD096331).

The study has been approved by:

The Duke Health Institutional Review Board (Pro00100678)
The UNC Institutional Review Board (IRB# 19-1066)
The UCLA Institutional Review Board (IRB# 19-000899)

Additional Resources

Federal guidelines require all NIH approved clinical trials made accessible for reference on clinicltrials.gov; our study identifier is NCT03844412.

Many individuals suffer from more than one chronic illness, and knowing who to turn to can be overwhelming. The Chronic Pain Research Alliance strives to put an end to the neglect, dismissal and discrimination faced by these individuals in the hopes of improving their quality of life and medical care.