Safety and Acceptability Study of MM008-IVR, an Antibody-Based Nonhormonal Contraceptive Intravaginal Ring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Number of Participants With Product-Related Adverse Events During Placebo IVR Use
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Provide written informed consent
- •Age of 18 - 45 years at enrollment
- •Female participants, born female
- •Willing and able to
- •communicate in English
- •complete all required study procedures
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo IVR
Participants will use a placebo IVR for 14 days.
干预措施: Placebo intravaginal ring (IVR) (Device)
结局指标
主要结局
Number of Participants With Product-Related Adverse Events During Placebo IVR Use
时间窗: 14 days
Determined by AE's, including colposcopy findings, that are deemed to be product related during placebo IVR use.
次要结局
- Device-only Tolerability and Acceptability(14 days)