Safety and Acceptability Study of a Placebo Antibody-Based Nonhormonal Contraceptive Intravaginal Ring

NCT06740253 | Completed Results FDA Device

• 2 other identifiers: 24-01941R43HD108823-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

In order to deliver nonhormonal vaginal contraceptive using anti-sperm antibodies, a new vaginal ring design using a capsule-IVR will be utilized. Evaluating the safety and acceptability of this device early in the product development cycle is important, not only because device/formulation characteristics become increasingly difficult to alter as product is advanced into clinical trials, but also because user adherence can directly impact clinical trial outcomes.

Conditions

Healthy Female Subjects

Keywords

Non-hormonal intravaginal ring

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Product-Related Adverse Events During Placebo IVR Use

  Determined by AE's, including colposcopy findings, that are deemed to be product related during placebo IVR use.

  14 days

Secondary Outcomes (1)

• Device-only Tolerability and Acceptability

  14 days

Other Outcomes (1)

• Changes in Pro-inflammatory Cytokines

  14 Days

Study Arms (1)

Placebo IVR

EXPERIMENTAL

Participants will use a placebo IVR for 14 days.

Device: Placebo intravaginal ring (IVR)

Interventions

Placebo intravaginal ring (IVR) DEVICE

Antibody-Based Nonhormonal Placebo Contraceptive Intravaginal Ring

Placebo IVR

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Only female born subjects are eligible to participate.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 for the first week of the study and until cleared by the study physician.

You may not qualify if:

• Participant reports any of the following:
• 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 screening examination.
• 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.
• 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.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• Mucommune, LLC.: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Results Point of Contact

• Title: PI Kathleen Vincent, MD
• Organization: University of Texas Medical Branch

klvincen@utmb.edu

4097722610

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study participants will be asked to use a placebo IVR to determine safety and acceptability for 14 days.

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 18, 2024
• Study Start: February 11, 2025
• Primary Completion: July 28, 2025
• Study Completion: July 28, 2025
• Last Updated: September 21, 2026
• Results First Posted: September 21, 2026

Record last verified: 2026-08

Locations

US (1)