EUCTR2013-005090-53-CZ进行中（未招募）1 期
A randomized, double-blind, double-dummy, parallel- group, multi-center phase IIb study to assess the efficacy and safety of different dose combinations of an aromatase inhibitor and a progestin in an intravaginal ring versus placebo and leuprorelin / leuprolide acetate in women with symptomatic endometriosis over a 12-week treatment period - ESPARIOS 1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 318
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Signed and dated informed consent.
- •2. Premenopausal women18 years and above at the time of screening.
- •3. Women with endometriosis confirmed by laparoscopy or laparotomy within the last ten years but not less than 8 weeks before the screening visit
- •In Japan, diagnosis based on imaging (transvaginal ultrasound or MRI) also qualifies for inclusion.
- •4. Moderate to severe endometriosis-associated pelvic pain (EAPP) of =5 in the last 28 days before screening visit 1 measured on the numeric rating scale (NRS; i.e. 4-week recall period).
- •5. At randomization: Adherence to the study procedures during the screening period, at least 24 diary entries of ESD item 1 during the last 28 consecutive days before the randomization visit, and a sum of the available ESD item 1 (‘worst pain’ on the daily NRS) entries during this period of at least 98 (corresponding to an average score of = 3.5).
- •6. Willingness to use only ibuprofen as rescue pain medication for EAPP, if needed according to investigator’s instruction.
- •7. Use of a non-hormonal barrier method (i.e. spermicide-coated condoms) for contraception from screening visit until the end of the study. This is not required if adequate contraception is achieved by vasectomy of the partner.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 318
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Pregnancy or lactation (less than three months since delivery, abortion, or lactation before start of treatment)
- •2. Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug
- •3. Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results.
- •4. Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator.
- •5. Undiagnosed abnormal genital bleeding
- •6. Wish for pregnancy during the study
- •7. Regular use of pain medication due to other underlying diseases
- •8. Non-responsiveness of endometriosis associated pelvic pain (EAPP) to GnRH-a or surgery (partial response is not exclusionary).
研究者
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