EUCTR2013-002300-13-BG进行中（未招募）不适用
A study to evaluate the effect on the endometrium of a new formulation containing 4 mg drospirenone (Drospirenone 4 mg film-coated tablet) administered over a period of 13 cycles. A monocentric, open, multiple dose trial in healthy female subjects at risk of pregnancy - Endometrium effect of an oral preparation containing 4 mg drospirenone
CHEMO France0 个研究点开始时间: 2013年9月26日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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. Healthy woman at risk of pregnancy
- •2. Age between 18 and 40 years at inclusion
- •3. At least four menstrual cycles during the last six months before screening were regular (i.e. cycle length between 24 and 35 days) in women previously not taking oral contraceptives (Starter”)
- •4. At least one regular menstrual cycle after the end of previous intake of oral contraceptives (Switcher”)
- •5. Systolic blood pressure <140 mmHg, diastolic blood pressure <90 mmHg, in sitting position, after 5 minutes of rest
- •6. Subject agrees to use the test product for contraception for at least 13 cycles
- •7. Menstruation restarted since last pregnancy (only applicable for women that were pregnant)
- •8. Laboratory values at screening with no deviations of any clinical relevance in the opinion of the investigator
- •9. Subjects with ability to follow study instructions and likely to attend and complete all required visits
- •10. Informed consent given in written form according to chapter 5.4 of the study protocol
- •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 22
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Hypersensitivity to the active substances or to any of the ingredients or excipients (for a list of ingredients and excipients see the Investigator’s brochure)
- •2. Pregnant or breastfeeding subject
- •3. Abnormal finding on pelvic, breast or ultrasound endometrial examination that precludes participation in the trial
- •4. Abnormal endometrial biopsy
- •5. Unexplained amenorrhea, known polycystic ovary syndrome
- •6. Papanicolaou cervical smear finding of atypical squamous cells of undetermined significance (ASC-US) or more severe according to the Bethesda system terminology
- •7. Significant cardiovascular, hepatic or renal disease
- •8. Diabetes with vascular involvement
- •9. Uncontrolled thyroid disorder
- •10. Current venous thrombosis
- •11. Known bleeding disorder or history of unexplained bleeding or bruising within the last 12 months prior to screening
- •12. Prohibited previous or concomitant medication:
- •12.1 Injectable hormonal methods of contraception within the last 6 months before screening and during the trial
- •12.2 Progestin-releasing intrauterine device or contraceptive implant within the last 2 months before screening and during the trial
- •12.3 Anti-retroviral therapy within the last 6 months before screening and during the trial
- •12.4 Estrogens during the trial
- •12.5 Progestogens during the trial
- •12.6 Activated charcoal taken within 3 hours before or after intake of the study drug
- •12.7 Longer than 5 days treatment during the trial with drugs or herbal products that may decrease the effectiveness of hormonal contraceptives (e.g. anticonvulsants like phenytoin, carbamazepine, oxcarbazepine, topiramate, felbamate, primidone) or barbiturates, rifampicin, atorvastatin, bosentan, griseofulvin,·phenylbutazone, St. John’s wort
- •(hypericum perforatum), medications that may increase serum potassium (ACE inhibitors, angiotensin – II receptor antagonists, potassiumsparing
- •diuretics, potassium supplementation, heparin, aldosterone antagonists and NSAIDs)
- •13. Simultaneous participation in another clinical study or participation in any clinical study involving an investigational drug within 3 months prior to start of the present study
- •14. Employee of the investigator or trial center, with direct involvement in the proposed trial or other studies under the direction of that investigator or trial center, or family member of the employees or the investigator
- •15. Severe physical or mental concomitant diseases that might hamper the realization of the trial according to protocol
- •16. History of alcohol or drug addiction
- •17. Legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the study
- •18. Unreliability or lack of cooperation
研究者
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