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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Female Subjects
• Intervention / Treatment: Device: Placebo intravaginal ring (IVR)

Detailed Description

There is a gap in commercially available reliable, effective contraception methods that do not contain hormones. Mucommune is developing a novel non-hormonal contraceptive in the form of a capsule-intravaginal ring (IVR) that releases highly potent contraceptive antibodies (MM008) that rapidly bind and trap sperm. These antibodies have been developed over the past 5 years and the target on sperm cells was initially obtained from a patient with infertility due to anti-sperm antibodies.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo IVR; Participants will use a placebo IVR for 14 days.	Device: Placebo intravaginal ring (IVR); Antibody-Based Nonhormonal Placebo Contraceptive Intravaginal Ring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Safety	Determined by AE's, including colposcopy findings, that are deemed to be product related during placebo IVR use.	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-only tolerability and acceptability	Device tolerability and acceptability as judged by scores on the questionnaires related to placebo IVR use. The scale that is used is a 5 point likert scale that assesses the degree to which the participant agrees or disagrees with a statement regarding the use of the intravaginal ring. Items will be factor analyzed and items will be summed by subscale with a higher score indicating greater agreement or a lower score indicating less agreement with a variety of statements about the ring and their experience of using the ring.	14 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in pro-inflammatory cytokines	Measures of proinflammatory cytokines at baseline and after placebo IVR use will be done using the ProcartaPlex Human Cytokine/Chemokine/Growth Factor Convenience Panel 1, 45plex. It allows for detection and quantification of up to 45 protein targets. This will be utilized to measure proinflammatory cytokines in the vaginal secretions. Increases in the proinflammatory cytokines indicate an increase in inflammation.	14 Days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2025
• Primary Completion (Actual): July 28, 2025
• Study Completion (Actual): July 28, 2025

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): December 18, 2024

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Non-hormonal intravaginal ring
• Other Study ID Numbers: 24-0194; 1R43HD108823-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No