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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
14
Antibody-Based Nonhormonal Placebo Contraceptive Intravaginal Ring
University of Texas Medical Branch
Galveston, Texas, United States
Number of Participants With Product-Related Adverse Events During Placebo IVR Use
Determined by AE's, including colposcopy findings, that are deemed to be product related during placebo IVR use.
Time frame: 14 days
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.
Time frame: 14 days
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