University of Texas Medical Branch
Galveston, Texas, 77555, United States
NCT Number: NCT06740253
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.
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Notify Me18 year–45 year
Female
Interventional
Not applicable
Galveston, Texas, 77555, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participant reports any of the following:
Note: Subjects may be treated and re-screened for participation.
Antibody-Based Nonhormonal Placebo Contraceptive Intravaginal Ring
Time frame: 14 days
Determined by AE's, including colposcopy findings, that are deemed to be product related during placebo IVR use.
Time frame: 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.
Time frame: 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.
The University of Texas Medical Branch, Galveston
Other
Safety and Acceptability Study of MM008-IVR, an Antibody-Based Nonhormonal Contraceptive Intravaginal Ring
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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