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 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
NCT ID:
NCT00595166
Eligibility Criteria:
Inclusion Criteria:
The following criteria must be present for randomization into the study:
Inclusion Criteria
* Age 18 to 64.
* BMI greater than 30.
* Collapsing vaginal tissue preventing the visualization of the cervix (meeting this criterion in the absence of a BMI \>30 would also qualify the patient for the study).
* Able to provide written informed consent
Exclusion Criteria:
The following criteria would exclude patients from randomization into the study:
* Patients unwilling to participate in the study or provide consent.
* Presence of dyspareunia (due to chronic pelvic pain, pelvic floor dysfunction, atrophic vaginitis, or any other etiology).
* Presence of other significant pelvic pain syndromes (interstitial cystitis, endometriosis).
* Presence of active genital herpes.
* Presence of significant condyloma acuminata (may be an investigator decision).
* Any other patient deemed inappropriate for the study by the consenting or examining investigator.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT00595166
Study Brief:
Protocol Section:
NCT00595166