Phase
Condition
N/ATreatment
Placebo intravaginal ring (IVR)
Clinical Study ID
Ages 18-45 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provide written informed consent
Age of 18 - 45 years at enrollment
Female participants, born female
Willing and able to
communicate in English
complete all required study procedures
- Subjects willing to abstain from vaginal intercourse and use of vaginal products forthe first week of the study and until cleared by the study physician.
Exclusion
Exclusion Criteria:
Participant reports any of the following:
Gynecologic or genital procedure (e.g., tubal ligation, dilation and curettage,piercing) within 21 days prior to Enrollment Note: Colposcopy and cervical biopsiesfor evaluation of an abnormal Pap smear as well as IUD removal are not exclusionary
Current use of an IVR (e.g., Nuvaring)
Prior hysterectomy
Females who are pregnant based on positive pregnancy test by urine HCG
Cervicovaginal inflammation or epithelial disruption on colposcopy at the screeningexamination.
Current active gynecological abnormalities or sexually transmitted infection and/orvaginal pathogens (e.g. gonorrhea, chlamydia, mycoplasma genitalium, trichomonas,candida species, bacterial vaginosis) at the screening examination. Note: Subjects may be treated and re-screened for participation.
Has any other condition or is participating in another research study that, in theopinion of the Principal Investigator or designee, would preclude informed consent,make study participation unsafe, complicate interpretation of study outcome data, orotherwise interfere with achieving study objectives.
Study Design
Study Description
Connect with a study center
University of Texas Medical Branch
Galveston, Texas 77555
United StatesActive - Recruiting
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