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| ID | Type | Description | Link |
|---|---|---|---|
| 1R43HD108823-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Mucommune, LLC. | UNKNOWN |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo IVR | Experimental | Participants will use a placebo IVR for 14 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo intravaginal ring (IVR) | Device | Antibody-Based Nonhormonal Placebo Contraceptive Intravaginal Ring |
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| 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 |
| 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. |
| 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. |
Inclusion Criteria:
Provide written informed consent
Age of 18 - 45 years at enrollment
Female participants, born female
Willing and able to
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:
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
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.
Only female born subjects are eligible to participate.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
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Study participants will be asked to use a placebo IVR to determine safety and acceptability for 14 days.
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| 14 days |
| 14 Days |