NCT07039591招募中1 期
A Randomized Open Label Crossover Trial to Assess Performance Attributes and Acceptability of Non-medicated Intravaginal Rings Among Sexually Active Women in Atlanta, GA
Population Council2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月8日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Mean Acceptability Score per IVR
研究概览
简要总结
A randomized open label crossover trial to assess performance attributes and acceptability of non-medicated intravaginal rings among sexually active women in Atlanta, GA
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •1. Cisgender female aged 18-49 years old, inclusive, at screening based on self-report.
- •2. Sexually active, defined as having penile-vaginal sex at least once a week, on average, over the past three months with the same male partner, and intends to continue having sexual intercourse at the current frequency for at least three months.
- •3. Healthy based on medical history, physical exam (including pelvic exam with visual inspection) at screening.
- •4. Using effective non-vaginal method of contraception (oral contraception, injectable, patch, IUD, sterilization, male condoms)
- •Competent to provide written informed consent based on Investigator's assessment.
- •6. Agrees to not participate in any other clinical research involving investigational or marketed products for the duration of this trial.
排除标准
- •1. Known or suspected allergy to silicone or EVA, as reported by participant.
- •Positive pregnancy test at screening or enrollment based on urine hCG test.
- •Positive for HIV at screening based on rapid test per site SOPs.
- •Presence of any clinically significant genital epithelial findings (e.g. abrasions, ulcerations, lacerations, or vesicles) at screening.
- •5. Positive chlamydia, gonorrhea, or trichomoniasis test at screening.
- •Symptomatic vulvovaginal candidiasis, bacterial vaginosis (BV), or urinary tract infection (UTI) at screening. (Participants who are symptomatic at initial screening will be referred for testing and treatment and may be reconsidered for eligibility after completing treatment and/or if no longer symptomatic).
- •7. Presence of genital abnormalities on visual exam with speculum that would contraindicate IVR use.
- •8. History of significant uterine or vaginal prolapse, or urethral obstruction.
- •Unexplained vaginal bleeding per self-report within the last three months.
- •Currently breastfeeding per self-report.
- •Partial or complete hysterectomy per self-report.
- •History of gynecological surgery in the six months prior to screening per self-report.
- •13. Within six weeks post abortion or six months postpartum, per self-report.
- •Using vaginal contraception (diaphragm, female condom, spermicide, IVR).
- •Known current drug abuse, including illicit drugs, or alcohol abuse.
- •Any other condition the clinician feels would jeopardize the health and wellbeing of the participant after assessing the participant's potential eligibility for the study.
- •17. Unable to comply with study requirements, including but not limited to, attending all study visits and using the IVRs as directed.
- •18. Participation in any other clinical research trial involving investigational or marketed products currently or within one month of participation prior to screening, including any trial of a spermicide, microbicide and/or drug.
结局指标
主要结局
Mean Acceptability Score per IVR
时间窗: From enrollment to the end of treatment at approximately 13 weeks
For the primary outcome we will compute the mean acceptability score per IVR, for each of three IVRs of different compression strengths. The scores women give each of the three rings will be compared using a mixed-effects model with orthogonal contrasts, with all 3 pairwise comparisons using the Bonferroni method to adjust for multiple comparisons.
次要结局
未报告次要终点
研究者
研究点 (2)
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