POSTMENOPAUSAL WOMEN WITH SEXUAL PAIN
We are conducting this clinical trial because all women need a safe, effective topical treatment for sexual pain without the use of hormones.
If you qualify you may receive at no cost:
- A topical botanical study investigational drug or placebo
- Study-related care from a local doctor
- Compensation for time and travel
You may be eligible if you:
- Are postmenopausal 70 years or younger
- Experiencing sexual pain
- Are not currently taking any form of estrogen (topical, patch or pill)
- Have regular access to email
- Other inclusion criteria may apply
Vestibulodynia Clinical Trial
Background: Many postmenopausal women experience pain when they touch or have sexual contact with the area located around the outside of the vaginal opening and extending outward towards the inner labia lips (this area is also called the vulvar vestibule). Many are unable or unwilling to use hormones such as estrogen.
In a preliminary trial it was found that a more dilute form of an FDA approved topical botanical drug, was strongly effective in both alleviating or eliminating their sexual pain, with the added benefits of increasing overall sexual function such as lubrication and arousal.
How the Clinical Trial works:
Overview: If you qualify, you will have three office visits with a female gynecologist over a period of six weeks, plus weekly confidential brief questionnaires to complete online. This is a placebo-controlled study which means that there is a 50/50 chance of receiving the study drug and a 50/50 chance of receiving a placebo ointment.
This Clinical Trial has been approved by a national Institutional Review Board and is registered with Clinicaltrials.gov. To view the study on the ClinicalTrials.gov site, CLICK HERE
What is expected from you:
- Topical Treatment: During the course of the six-week study, you will be asked to apply a small amount of topical ointment to the areas discussed with the gynecologist at your first office visit and once a day for a total of six weeks. You will not know if you are receiving the study drug or the placebo.
- Office Visits: You will be seen three times in the gynecologist’s office over a period of six weeks. At each of these three visits she will examine the vulvar area with a cotton Q-tip to assess whether you have less pain.
- Questionnaires: On each of your three office visits you will be asked to complete confidential questionnaires coded to protect your identity about your symptoms and sexual function. You will also receive an email reminder at the end of week 1, 2, 4 and 5 asking you to fill out two short confidential questionnaires online on a HIPAA compliant website. Instructions will be given.
- Study Completion: At the end of six weeks, you will be seen for your last office study visit and exam with the gynecologist. You will stop using your tube of ointment. Nothing more is required of you until at the end of two more weeks. After not using the ointment for two weeks, you will receive an email requesting that you fill out the final set of questionnaires. This is important to determine the durability of the effects, benefits, that you may have experienced.
How can I participate in the Clinical Trial?
Thank you for your interest in this Clinical Trial. If you qualify to participate you will be instrumental in helping find a safe and effective alternative for the alleviation of sexual pain in postmenopausal women.
If you have any questions about the Clinical Trial and want an opportunity to join, please email the Clinical Trial Coordinator, Annamarie DiRosa, Patient Assistant, at firstname.lastname@example.org or use the form below.