The Efficacy and Safety of an Intravaginal Acetic Acid Thermoreversible Gel on Chinese Women of Reproductive Age Compared With Nonoxinol Gel: A Multi-central Phase II, Triple-blind, Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Termination rate during three months
研究概览
简要总结
The study aims to explore the efficacy and safety of an intravaginal acetic acid thermoreversible gel in Chinese women of reproductive age, comparing it with nonoxinol gel by assessing the six-month Pearl Index and the incidence of any side effects.
详细描述
Despite significant increases in the availability and effectiveness of contraceptives globally, there are few female-led devices that combine contraception and STI prevention. Previous studies suggested that acetic acid thermoreversible gel, a female targeted contraception, can regulate intravaginal ph, killing sperm and STI pathogens and protecting intravaginal probiotics. Therefore, we have developed a contraceptive gel containing 11.23 mg/g of poloxamer 407-acetic acid. To determine its contraceptive effectiveness and safety compared with the widely used nonoxinol gel, we will recruit about 240 reproductive-aged women in four centers in China and randomly allocate into two groups. During a six-month follow-up, we will compared their pregnant rates and incidence of adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged between 20 and 45 years old;
- •Regular menstrual cycles (cycle length 25-35 days, menstruation lasting up to 7 days);
- •Have a history of pregnancy with the current partner at least once;
- •Currently engaging in regular sexual activity and planning to do so in the next six months (at least once a week);
- •Have not used hormonal contraceptive methods in the past 3 months;
- •Normal menstrual cycles have resumed after the removal of an intrauterine device;
- •Normal menstrual cycles have resumed after a previous miscarriage;
- •Breastfeeding women with normal menstrual cycles resumed;
- •No apparent gynecological abnormalities confirmed through examination, and normal cervical cytology (Pap smear grade I according to the Bethesda system);
- •Reliance on the investigational drug as the sole contraceptive method during the study period;
- •Willing to participate in this study, adhere to required follow-up visits, and voluntarily sign the informed consent form.
排除标准
- •Amenorrhoea for more than 1 month, suspected pregnancy;
- •Moderate to severe erosive changes in the cervix;
- •Vaginal cleanliness grade III or above;
- •Trichomonas, fungal vaginitis, and bacterial vaginosis, among other conditions, have not been cured;
- •Uterine prolapse of degree II or above and severe protrusion of the anterior and posterior vaginal walls;
- •Unexplained vaginal bleeding;
- •Genital tract deformities;
- •Malignant tumors of the genital tract;
- •Moderate or severe urinary incontinence;
- •Recurrent urinary tract infections;
- •History of allergy to acetic acid and/or nonoxinol.
研究组 & 干预措施
Intervention group
An acetic acid thermoreversible gel developed by Shanghai Jinxiang Latex Products Co. will be allocated to the intervention group.
干预措施: ancetate gel (Drug)
Controlled group
Nonoxinol gel produced by China Pharmaceutical University Pharmacy Co., Ltd will be allocated to the cotrolled group.
干预措施: nonoxinol gel (Drug)
结局指标
主要结局
Termination rate during three months
时间窗: Three months
The termination due to any complications will be observed respectively in both groups during the first three months.
Termination rate during six months
时间窗: Six months
The termination due to any complications will be observed respectively in both groups during the whole six months.
Failure rate
时间窗: Six months
Pregnancy due to contraceptive failure under correct use and pregnancy due to incorrect and or discontinuous use will be respectively observed for six months for both groups.
Pregnancy rate during three months
时间窗: Three months
A cumulative incidence will be calculated according to the number of pregnancies during the first three months.
Pregnancy rate during six months
时间窗: Six months
A cumulative incidence will be calculated according to the number of pregnancies during the whole six months.
次要结局
- Complaint of adverse reactions(Six months)
- Biochemical index(Six months)
- Adherence use(Six months)
- Vaginal internal environment(Six months)
- Concomitant drugs(Six months)