Testing a new non-hormonal contraceptive vaginal ring

Safety and Acceptability Study of MM008-IVR, an Antibody-Based Nonhormonal Contraceptive Intravaginal Ring

This study is testing a new non-hormonal vaginal ring that releases antibodies to prevent pregnancy and is looking to see if it's safe and easy for people to use.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: The University of Texas Medical Branch, Galveston (other)
• Locations: 1 site (Galveston, Texas)
• Trial ID: NCT06740253 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and acceptability of a novel non-hormonal contraceptive intravaginal ring that releases anti-sperm antibodies to prevent pregnancy. The ring is designed to be user-friendly and aims to fill the gap in effective contraceptive methods that do not involve hormones. Participants will be monitored for their adherence to the device and any side effects during the initial phase of product development. The study is crucial for understanding user experience and ensuring the device's effectiveness before advancing to larger clinical trials.

Who should consider this trial

Good fit: Ideal candidates are healthy females aged 18 to 45 who can provide informed consent and are willing to abstain from vaginal intercourse during the initial study period.

Not a fit: Patients who are currently pregnant, have had a hysterectomy, or have active gynecological abnormalities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide women with a reliable non-hormonal contraceptive option.

How similar studies have performed: While there is limited data on similar non-hormonal contraceptive methods, the innovative approach of using anti-sperm antibodies represents a novel direction in contraceptive development.

Eligibility criteria

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.

Where this trial is running

Galveston, Texas

• University of Texas Medical Branch — Galveston, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Kathleen Vincent, MD

Conditions: Healthy Female Subjects, Non-hormonal intravaginal ring