Prospective, Multicenter, Open-label and Non-randomized Trial on Contraceptive Efficacy, Safety and Tolerability of LVS (Levonorgestrel Vaginal System) During 13 Cycles
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,600
- 主要终点
- Pregnancy
研究概览
简要总结
The goal of this clinical trial is to learn if drug levonorgestrel vaginal ring works as a contraceptive adult and adolescent females who are able to conceive (i.e. get pregnant). It will also learn about the safety and tolerability of levonorgestrel vaginal ring. The main questions it aims to answer are:
Does drug levonorgestrel vaginal ring lower the number of pregnancies with continued use? What adverse effects do participants experience by using levonorestrel vaginal ring? Researchers will count the number of pregnancies with levonorgestrel vaginal ring after a participant uses it for a year to see if the number of pregnancies is low (i.e. women and girls do not get pregnant).
Participants will:
Use levonorgestrel vaginal ring for 28 days (called one cycle); for a total of 14 cycles (which is a little more than year) Visit the clinic about 8 to 10 times over about 14 months for checkups and tests with an additional approximately 13 phone calls Keep a diary of their pregnancies and number of times they use additional contraceptive (e.g. condoms)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female between age 13 and 45 years
- •Sexually active and of child-bearing potential
- •Not pregnant with regular menstrual cycles
- •Blood pressure: ≤ 140 mmHg systolic and ≤ 90 mmHg diastolic
排除标准
- •Pregnant or desire of pregnancy
- •Amenorrhea
- •History of infertility or menopause or reproductive sterility
- •Male sexual partner with infertility/sterility
- •Known bleeding disorder or history of unknown bleeding/bruising
- •Abnormal clinically significant findings on laboratory tests, physical, pelvic, breast, or ultrasound examination
- •Papanicolaou (Pap) smear reading of low-grade squamous intraepithelial lesion (LSIL) or higher at screening
- •History of: VTE, cardiovascular disease, major surgeries, diabetes mellitus, severe hepatic disease, renal insufficiency, adrenal insufficiency, sex steroid sensitive malignancy, breast cancer, HPV infections
- •Uncontrolled chronic disease
- •Severe DOCID-19
- •Progestin releasing IUD use, implant contraception use
- •Planned regular use of barrier contraceptive methods, spermicide, IUDs, other contraceptive measures
研究组 & 干预措施
Levonorgestrel Vaginal Rind
Levonorgestrel formulated in a vaginal ring for continuous 28 day use
干预措施: Levonorgestrel (Drug)
结局指标
主要结局
Pregnancy
时间窗: Baseline, Month 1, Month 3, Month 6, Month 9, Month 13
Pregnancy test (urine and/or blood test)
次要结局
- Safety - adverse events(Baseline, Month 1, Month 3, Month 6, Month 9, Month 13)
- safety - liver function(Baseline, Month 6, Month 13)
- safety - kidney function(Baseline, Month 6, Month 13)