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

Last updated: February 26, 2025
Sponsor: The University of Texas Medical Branch, Galveston
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Placebo intravaginal ring (IVR)

Clinical Study ID

NCT06740253
24-0194
1R43HD108823-01
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

  1. 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:

  1. 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

  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 screeningexamination.

  6. 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.

  7. 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

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Placebo intravaginal ring (IVR)
Phase:
Study Start date:
April 01, 2025
Estimated Completion Date:
July 31, 2026

Study 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.

Connect with a study center

  • University of Texas Medical Branch

    Galveston, Texas 77555
    United States

    Active - Recruiting

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