EUCTR2011-005573-23-NL进行中（未招募）不适用
A prospective, randomized, double-blind parallel-arm, placebo-controlled study to assess the effects on ovarian activity of a combined oral contraceptive pill when preceded by the intake of ellaOne® (ulipristal acetate 30 mg) or placebo - Not applicable
aboratoire HRA Pharma0 个研究点目标入组 85 人开始时间: 2012年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 85
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
- •Healthy women aged 18-35 years old
- •BMI < 30 Kg/m2
- •Not at risk of pregnancy:
- •-not sexually active,
- •-willing to protect all further acts of intercourse with condoms until last study visit, or
- •-partner sterilized or vasectomized
- •No use of progesterone-only-pill for 3 months before start of treatment cycle
- •No use of implant hormonal contraception for 3 months before start of treatment cycle
- •No use of levonorgestrel intrauterine system for 3 months before start of treatment cycle
- •No use of depo provera for 12 months before start of treatment cycle
- •Women must be able to and willing to give voluntary, written informed consent to participate in the study, and must agree to observe all study requirements
- •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 85
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnant (positive urinary pregnancy test) or less than 4 weeks postpartum
- •Currently breastfeeding
- •Current use of an intra-uterine device (IUD)
- •Use of any other hormonal contraception than the study medication during the treatment cycle
- •Irregular menstrual cycles (before the onset of the contraceptive method for women under hormonal contraception at screening visit)
- •Follicle-like structure (FLS) >13mm observed on transvaginal ultrasound (TVU) performed at baseline visit
- •Dominant follicle size =13mm observed on TVU at day 18 (+/- 1 day) during the pre-treatment period
- •Last Pap smear performed was abnormal (high-grade squamous intra-epithelial lesions or higher)
- •Suspected hyperplasia or carcinoma of the endometrium
- •Cancer (past history of any carcinoma or sarcoma)
- •Known or suspected alcoholism or drug abuse
- •Known abnormal thyroid status
- •Chronic treatment with oral glucocorticoids
- •Hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •Known hypersensitivity to the ingredients of the test active substances or excipients namely, lactose monohydrate, povidone, croscarmellose sodium, magnesium stearate, maize starch, macrogol, calcium carbonate, glycerol, titanium dioxide, yellow ferric oxide pigment, montan glycol wax, talc
- •Any contraindications to Microgynon 30® (per SPC) other than already listed (known hypertension (adequately controlled) or current elevated blood pressure >140/90; migraine with aura; current or history of confirmed venous thromboembolism; current or previous arterial thrombotic or embolic processes; known thrombogenic mutations; diabetes mellitus with vascular changes; sickle-cell anaemia; severe disturbances of liver function, active current hepatitis, previous or existing liver tumours; jaundice or persistent itching during a previous pregnancy; Dubin-Johnson syndrome; rotor syndrome; current or medically treated gallbladder disease; disorders of lipid metabolism; history of herpes gestationis, deterioration of otosclerosis during pregnancy)
- •Concomitant use of medication thought to interact with ellaOne® or COCP during study participation
- •-Oral antidiabetics or insulin
- •-Concomitant use of the PGP substrates during study participation (e.g. alpha-methyldigoxin, amitriptyline, beta-acetyldigoxin, carbamazepine, cetirizine, chlorpromazine, citalopram, digoxin, doxepine, fexofenadine, glyburide, LAAM (Levo-Alpha Acetyl Methadol), morphine, nortriptyline, olanzapine, ondansetron, paroxetine, pentazocaine, phenobarbital, phenytoin, quetiapine, risperidone, sertraline, terfenadine, topiramate, trimipramine and venlafaxine)
- •-Concomitant use of liver enzyme inducers (e.g. rifampicin, phenytoin, Phenobarbital, carbamazepine, ritonavir, St John’s wort/ Hypericum perforatum) during study participation
- •-Concomitant use of potent liver enzyme inhibitors (e.g. ketoconazole, itraconazole, telithromycin, clarithromycin, nefazodone) during study participation
- •-Concomitant administration of medicinal products that increase gastric pH (e.g. proton pump inhibitors, antacids and H2-receptor antagonists) during study participation
- •Current participation in any other trial of an investigational medicine or participation in the past three months before start of treatment cycle
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