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临床试验/NCT01204190
NCT01204190已完成2 期

Multicenter, Open-label, Randomized Study to Evaluate Inhibition of Ovulation During Treatment With Three Transdermal Patch Formulations Containing 0.55 mg Ethinylestradiol (EE) and 2.10 mg Gestodene (GSD) or 0.35 mg EE and 0.67 mg GSD or 0.275 mg EE and 1.05 mg GSD in Healthy Young Female Volunteers Over a Period of 3 Treatment Cycles

Bayer0 个研究点目标入组 173 人开始时间: 2010年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
Bayer
入组人数
173
主要终点
Hoogland score to evaluate the inhibition of ovulation

研究概览

简要总结

The primary objective of this trial is to examine whether ovulation is suppressed after use of hormone patches containing different dosages of ethinyl estradiol (EE) and gestodene (GSD) for 3 treatment cycles. To this end, the blood levels of endogenous hormones (hormones produced by your body) will be measured and transvaginal ultrasound examinations will be conducted at regular intervals. In addition, the concentrations of the administered hormones EE and GSD in blood will be determined in regular intervals.

With regard to the tolerability of the hormone patches subjects will be asked regularly how they feel and blood pressure, pulse and body weight will be determined. In addition, blood and urine safety examinations will be conducted at defined timepoints.

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
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy female volunteers
  • age 18 - 35 years (smoker not older than 30 years, inclusive)
  • ovulatory pre-treatment cycle

排除标准

  • Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous or arterial thromboembolic disease)
  • Regular intake of medication other than Oral Contraception
  • Clinically relevant findings (blood pressure, physical and gynecological examination, laboratory examination)

研究组 & 干预措施

Arm 1

Experimental

干预措施: Gestodene/EE Patch (BAY86-5016) (Drug)

Arm 2

Experimental

干预措施: Gestodene/EE Patch (BAY86-5016) (Drug)

Arm 3

Experimental

干预措施: Gestodene/EE Patch (BAY86-5016) (Drug)

结局指标

主要结局

Hoogland score to evaluate the inhibition of ovulation

时间窗: After 2 months

次要结局

  • Blood level time course of gonadotropins i.e. follicle stimulating hormone (FSH) and luteinizing formone (LH) as well as steroid hormones estradiol and progesterone(After 2 months)
  • Follicle size measured by transvaginal ultrasound examination(After 2 months)
  • Pharmacokinetics of ethinyl estradiol (EE), gestodene (GSD) and sex hormone binding globuline (SHBG)(After 2 months)

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

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