Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-24 @ 5:40 PM
NCT ID:
NCT02369068
Eligibility Criteria:
Inclusion Criteria:
* Provide informed consent
* Healthy women \> age 18 regardless of menopausal status
* Willing and able to fill out study questionnaires. In patients that are unable to read, the research nurse will be available to assist.
* High-tone pelvic floor dysfunction on vaginal exam
* A pelvic pain score of \> 4 on screening Visual Analog Scale (VAS)
* Pain perceived to be in the pelvis that has been present for at least 3 months.
Exclusion Criteria:
* Patients that have had Botox to the bladder within the last 8 months
* Patients that have had Botox outside the bladder of \> 160 u within the last 12 weeks.
* Patients that have had transvaginal trigger point injections of any form (Botox or steroid) in the last 3 months
* Pregnancy
* Concomitant use of any narcotic drug, alcohol, or any illicit drug use during the study period that could be deemed unsafe in combination with study medication as judged by the investigators.
* Any evidence of vaginitis on wet mount slide at initial visit that is untreated.
* Subject with any other vaginal epithelial disorder that could affect absorption of medication as deemed by the investigators.
* Any indication/condition/medication that the investigators identify as contraindicated in conjunction with study medication.
* Systolic blood pressure \> 160 mm Hg on screening blood pressure
* Heart rate \> 110 beats/minute on screening heart rate
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02369068
Study Brief:
Protocol Section:
NCT02369068