Healthy Female Subjects
Conditions
Keywords
Non-hormonal intravaginal ring
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.
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.
Interventions
Antibody-Based Nonhormonal Placebo Contraceptive Intravaginal Ring
Sponsors
Mucommune, LLC.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The University of Texas Medical Branch, Galveston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Study participants will be asked to use a placebo IVR to determine safety and acceptability for 14 days.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Safety | 14 days | Determined by AE's, including colposcopy findings, that are deemed to be product related during placebo IVR use. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device-only tolerability and acceptability | 14 days | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in pro-inflammatory cytokines | 14 Days | 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. |
Countries
United States
Outcome results
None listed