EUCTR2010-019865-26-FI进行中（未招募）1 期
A randomised, open-label, multi-centre, dose-finding study to evaluate cycle control of 15 mg or 20 mg estetrol combined with either 150 µg levonorgestrel or 3 mg drospirenone, compared to a combined oral contraceptive containing estradiol valerate and dienogest. - FIESTA study
Estetra S.A.0 个研究点开始时间: 2010年5月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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.Women aged 18-35 years (inclusive) at the time of screening who are willing to use a COC for 4 subsequent cycles
- •2.Good physical and mental health as judged by the investigator determined by medical history, physical examination, clinical laboratory and vital signs
- •3.Regular menstrual cycle (24-35 days) prior to screening
- •4.Body mass index between (=) 18 and (=) 30 kg/m2
- •5.Willing to give informed consent in writing
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Previous use of any hormonal contraceptive method during the last 3 months prior to randomisation (exclusion criterion only applicable for women who are not using a hormonal contraceptive method at the time of screening)
- •2.Previous use of progestogen-only contraceptive methods (e.g. minipill, implant or IUD) during the last 3 months or during the last 6 months for depot progestogen preparations or an injectable hormonal method of contraception (e.g. Depo-provera®)
- •3.Use of phytoestrogens
- •4.No spontaneous menstruation has occurred following a delivery or abortion
- •5.Breastfeeding or within 2 months after stopping breastfeeding prior to the start of study medication and no spontaneous return of menstruation
- •6.Status post-partum or post-abortion within a period of 2 months before screening
- •7.Pregnancy during accurate hormonal contraceptive use in the past
- •8.Intention to become pregnant during the study
- •9.An abnormal cervical smear
- •10.Untreated Chlamydia infection
- •11.Known or suspected breast cancer or a history of breast cancer
- •12.A history of (within 12 months) alcohol or drug abuse
- •13.Any clinically relevant abnormality following review of medical history, laboratory results and physical/gynaecological examination at screening as judged by the investigator;
- •14.Contraindications for contraceptive steroids
- •15.In accordance with the SmPC/Package Insert of DRSP-EE, additional contraindications related to the antimineralocorticoid activity of drospirenone
- •16.Use of one or more of the following medications:
- •-Antihypertensive drugs
- •-Present use or use within 2 months prior to the start of the study medication of the following drugs: phenytoin, barbiturates, primidone, carbamazapine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex steroids (other than pre- and post treatment contraceptive method) and herbal remedies containing Hypericum perforatum (St John’s Wort);
- •17.Administration of any other investigational drug within 2 months prior to screening.
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