プラセボ抗体ベースの非ホルモン性避妊薬膣内リングの安全性と受容性の研究

Inclusion Criteria:

1. Provide written informed consent

2. Age of 18 - 45 years at enrollment

3. Female participants, born female

4. Willing and able to

   • communicate in English
   • complete all required study procedures

5. Subjects willing to abstain from vaginal intercourse and use of vaginal products for the first week of the study and until cleared by the study physician.

Exclusion Criteria:

Participant reports any of the following:

1. Gynecologic or genital procedure (e.g., tubal ligation, dilation and curettage, piercing) within 21 days prior to Enrollment Note: Colposcopy and cervical biopsies for evaluation of an abnormal Pap smear as well as IUD removal are not exclusionary

2. Current use of an IVR (e.g., Nuvaring)

3. Prior hysterectomy

4. Females who are pregnant based on positive pregnancy test by urine HCG

5. Cervicovaginal inflammation or epithelial disruption on colposcopy at the screening examination.

6. Current active gynecological abnormalities or sexually transmitted infection and/or vaginal 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.

7. Has any other condition or is participating in another research study that, in the opinion of the Principal Investigator or designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives.