COMPLETED

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

Conditions

Healthy Female Subjects Non-hormonal intravaginal ring

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-11

Study Completion:2025-07-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06740253

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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. 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.

Inclusion Criteria

Exclusion 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.

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.
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.

Contacts and Locations

Study Locations (Sites)

University of Texas Medical Branch

Galveston, Texas, 77555

United States

Collaborators and Investigators

Sponsor: The University of Texas Medical Branch, Galveston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-11

Study Completion Date2025-07-28

Study Record Updates

Study Start Date2025-02-11

Study Completion Date2025-07-28

Terms related to this study

Keywords Provided by Researchers

Non-hormonal intravaginal ring

Additional Relevant MeSH Terms

Healthy Female Subjects