NCT04553068已完成3 期
Phase 3 Double-blind Placebo-controlled Efficacy Trial of EVO100 Vaginal Gel for the Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Evofem Inc.
- 入组人数
- 1,892
- 试验地点
- 91
- 主要终点
- Percentage of Study Successes in the EVO100 and Placebo Treatment Groups
研究概览
简要总结
This study will evaluate whether EVO100 vaginal gel prevents the sexual transmission of CT and GC infection
详细描述
In this phase 3 double blind placebo controlled, efficacy study, women who have had a urogenital chlamydia or gonorrhea infection at any time over the 16 weeks preceding the enrollment Visit with one or more risk factors, or found to be positive for either infection at Screening Visit with one or more risk factors will be enrolled. After a screening period of up to 35 days, women will be randomized to receive either EVO100 vaginal gel or placebo. Each woman will participate in the study until she has completed 16 weeks of study medication or observation or tests positive for CT or GC infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects must meet both of the following criteria:
- •Urogenital CT and/or GC infection (documented in a retrievable medical record) within the 16 weeks prior to enrollment and one or more of the additional risk factors included below:
- •18 to 24 years of age at the screening visit
- •New sex partner within the past 12 weeks (84 days)
- •More than one current sex partner
- •Knowledge that current sex partner has multiple partners
- •Partner with known sexually transmitted infection (STI)
- •Inconsistent condom use among persons who are not in a mutually monogamous relationship
- •After three unsuccessful documented attempts to obtain medical records, the subject has a self-reported history of infection less than 17 weeks prior to enrollment AND two or more of the following additional risk factors:
- •18 to 24 years of age at the screening visit
- •New sex partner within the past 12 weeks (84 days)
- •More than one current sex partner
- •Knowledge that current sex partner has multiple partners
- •Partner with known STI
- •Inconsistent condom use among persons who are not in a mutually monogamous relationship
- •Ability to understand the consent process and procedures. For minors, the ability to obtain consent from parents/legal guardian and assent by minor subjects as applicable according to local regulations.
- •Agree to be available for all study visits including Visit 5 and follow-up Visit 6 and comply with follow-up on staff appointment reminders
- •Negative pregnancy test
- •Negative CT and GC nucleic acid amplification test (NAAT) at screening or positive CT or GC NAAT and receives standard of care (SOC according to CDC or World Health Organization [WHO] guidelines) treatment prior to enrollment with subsequent negative CT and GC NAAT testing at enrollment visit
- •Agree to use a woman-controlled method of contraception that is not directly delivered to the vaginal mucosa (with the exception of a vaginal ring) throughout the duration of the study, such as oral contraceptives, birth control implants, intrauterine devices (IUDs), or tubal ligation. Condom use only is not an acceptable form of contraception for this study
- •Able and willing to comply with all study procedures, including the use of eDiaries and reporting of all Adverse Events and concomitant medications.
- •Reports vaginal sexual intercourse with a male partner at least three times per month in the previous month and anticipates vaginal sexual intercourse regularly for the duration of the study
- •Agree to abstain from douching or any form of vaginal suppository use (other than investigational product) during course of study
排除标准
- •In the opinion of the Investigator, has a history of substance or alcohol abuse in the last 12 months or, has issues, conditions, or concerns that may compromise the safety of the subject, impact the subject's compliance with the protocol requirements, or confound the reliability of the data acquired
- •Women who have undergone a total hysterectomy (had uterus and cervix removed). However, women with subtotal hysterectomy with an intact cervix may be enrolled
- •Has a history or expectation of noncompliance with medications or intervention protocol
- •Has engaged in sexual vaginal intercourse or douching, or used of any form of vaginal suppository or intravaginal device (with the exception of contraceptive vaginal ring or tampons) for 24 hours prior to enrollment (may be enrolled at a later date if all other criteria are met)
- •Menstruating at enrollment (may be enrolled at a later date if all other criteria are met)
- •Is currently being treated, or has been treated, for a period of 21 days prior to enrollment, with any prohibited antibiotics. The prohibited antibiotics include azithromycin, erythromycin, doxycycline, levofloxacin, ofloxacin, ceftriaxone, and cefixime.
- •In the opinion of the Investigator, has signs/symptoms that indicate persistence of CT or GC infection diagnosed at screening, new interval infection, and/or a failure to comply with or complete the prescribed treatment regimen following a positive screening NAAT
研究组 & 干预措施
EVO100 gel
Experimental
EVO100 vaginal gel, 5 g
干预措施: EVO100 (Drug)
Placebo gel
Placebo Comparator
Placebo vaginal gel, 5 g
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Study Successes in the EVO100 and Placebo Treatment Groups
时间窗: 16 weeks
Percentage of subjects who are defined study successes among the intervention groups with success defined as subjects completing the trial to Visit 5 without any CT or GC infection and no usage of prohibited antibiotics during the study.
次要结局
- Evaluate Safety of EVO100: AEs(16 weeks)
研究者
研究点 (91)
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