"Quick-starting" of a New Combined Hormonal Contraceptive Pills, 15 mg Estetrol/3 mg Drospirenone VS 20 mcg Ethinylestradiol/75 mcg Gestodene Focusing on Ovulation Inhibition: A Single-blind, Randomized Controlled, Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Rate of ovulation inhibition and classify ovarian activities using transvaginal ultrasound
研究概览
简要总结
The goal of this clinical trial is to learn if Estetrol/Drospirenone inhibit ovulation in quick-starting method. It will also learn about the safety of Estetrol/Drospirenone. The main questions it aims to answer are:
- Does Estetrol/Drospirenone inhibit ovulation inferior to Ethinyl estradiol/Gestodene when starting on Day 7-9 of menstrual cycle?
- What are the impacts of Estetrol/Drospirenone on ovarian activities when starting on Day 7-9 of menstrual cycle?
- How does the cervical mucus change when starting Estetrol/Drospirenone on Day 7-9 of menstrual cycle?
- What are the adverse effects when starting Estetrol/Drospirenone on Day 7-9 of menstrual cycle?
Researchers will compare Estetrol/Drospirenone to Ethinyl estradiol/Gestodene to see if Estetrol/Drospirenone inhibit ovulation in quick-starting method.
详细描述
Participants will:
Take Estetrol/Drospirenone or Ethinyl estradiol/Gestodene starting on day 7-9 of menstrual cycle then every day for 1 pack of the pills.
Visit the clinic on day 1-2, day 7-9, and then every 2-7 days according to ultrasound finding (ovarian activities) until completing of pills to investigate
- Transvaginal ultrasound
- Cervical mucus
- Serum hormonal profiles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Women aged 18 - 45 years old
- •Body mass index 18-30 kg/m²
- •Menstrual interval within 24 - 38 days
- •Absence of history of estrogen or progestin allergy and Absence of these compatibles with U.S. medical eligibility criteria category 3 - 4
- •Consent to use condom as contraception or have been sterilized
排除标准
- •History of estrogen, progestin or testosterone use within 3 months
- •Current pregnant or within 3 months of breastfeeding
- •Having ovarian cyst(s) or tumor(s)
- •Being a cervical cancer patient or having precancerous cervical lesion
研究组 & 干预措施
Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7)
干预措施: Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7) (Drug)
Estetrol 15 mg/Drospirenone 3 mg (24/4)
干预措施: Estetrol 15 mg/Drospirenone 3 mg (24/4) (Drug)
结局指标
主要结局
Rate of ovulation inhibition and classify ovarian activities using transvaginal ultrasound
时间窗: 34-36 days
Visit the clinic on day 1-2, day 7-9, and then every 2-7 days according to ultrasound finding until completing a package of pills * Ultrasound will be perform by the researcher (Dr. Sirarat Itthipuripat) using transvaginal probe to all volunteers. * To monitor a leading ovarian follicle or follicle-like structures (FLS), that the ultrasound characteristic is the largest hypoechoic part (follicle) among both ovaries, to classify the ovarian activity by modified Hoogland's score (combined the result with hormonal profile: Estradiol, Progesterone) and assess rate of ovulation, that identify from postovulatory image defined as follows: * Image observed after abrupt disappearance of FLS or * Image observed after reduction in size of the leading follicle \> 4 mm at 2 consecutive visits or * Hemorrhagic or cystic corpus luteum * The detail in measuring the size of an FLS is the average of 3 longest sides perpendicular to each other in millimeter
次要结局
- Level of serum hormonal profiles: Estradiol, Progesterone, LH(Cervical mucus classification)
- Cervical mucus(34-36 days)