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:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT03151967
Eligibility Criteria:
Inclusion Criteria:
* pre-menopausal women
* present with an acute, uncomplicated, culture confirmed UTI, defined as dysuria, urgency and/or frequency
* at least one previous medically diagnosed UTI in past 12 months
* using a reliable method of birth control ie: history of tubal ligation, male partner with vasectomy, steroidal contraception, Nuva-Ring, IUD, use of non spermicidal condoms or abstinence.
* can provide written consent
* can understand and read English
Exclusion Criteria:
* history of urogenital infection within the past 30 days, including: UTI, medically diagnosed vaginitis
* current symptoms suggestive of pyelonephritis (fever\>100.4, flank pain of costovertebral angle tenderness, nausea and vomiting
* history of functional or anatomic urologic abnormalities, urologic surgery of chronic urinary catheterization
* history of pyelonephritis within the past 6 months
* diagnosis of N. gonorrhoeae, C. trachomatis or T. vaginalis on two or more occasions during previous six months
* known HIV infection of seropositivity
* investigational drug use within 30 days of enrollment visit or current participation in another clinical trial
* diabetes, other significant medical problem or intercurrent acute illness that in the Nurse Practitioner's and/or Principal Investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objective.
At the randomization visit, has any of the following findings on pelvic or other physical examination:
* unable to visualize cervix
* clinically significant abnormalities, such as inflammation, erosion and/or petechiae (bleeding under the skin) of external genitalia, vaginal or cervix on visual examination
* clinically significant tenderness on bimanual examination during the pelvic examination
* evidence of vaginitis or a sexually-transmitted disease
* any diagnosis requiring antibiotics
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03151967
Study Brief:
Protocol Section:
NCT03151967