EUCTR2009-011858-17-NL进行中（未招募）不适用
A dose finding study with an active control group (Yasmin) to assess the contraceptive efficacy and the efficacy on liver function of estetrol combined with 3 mg drospirenone by daily oral administration to healthy female volunteers for 3 cycles of 24 days each followed by a 4 day treatment pause. - DOC-2
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •At least 18 years and not older than 35 years of age
- •Willing to use a barrier method of contraception during the entire trial
- •Women who ovulate in the pre-treatment cycle between day 9 (± 1) and day 24 (± 1) after start of their menses and whose next menstruation does not start within 6 days after ovulation.
- •Body Mass Index between 18 and 30 kg/m2
- •Good physical and mental health
- •Both ovaries visible upon vaginal ultrasonography
- •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
- •Clinically significant abnormal results of routine haematology, serum biochemistry, urinalysis, and/or ECG in the opinion of the investigator at screening.
- •Women with a washout cycle with a duration > 42 days
- •Known or suspected pregnancy
- •Pregnancy during accurate hormonal contraceptive use in the past
- •Known or suspected breast cancer or a history of breast cancer
- •Clinically significant abnormalities of the uterus and/or ovaries detected by examination and/or ultrasound (non-physiological ovarian mass or significant uterine pathology).
- •A cervical smear with clinically relevant abnormal cytology within three years before study start (defined as signing of informed consent).
- •Previous use of depot progestogen preparations or progestogen injectables in the last 6 months.
- •Contraindications for contraceptive steroids
- •In accordance with the SmPC/Package Insert of EE/DRSP, additional contraindications related to the antimineralocorticoid activity of drospirenone (conditions that predispose to hyperkaliema including hyperkaliema medication):
- •-Renal insufficiency
- •-Hepatic dysfunction
- •-Adrenal insufficiency
- •Use of one or more of the following medications:
- •-Antihypertensive drugs
- •-Present use or use within 60 days prior to 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 the study medication) and herbal remedies containing Hypericum perforatum (St John’s Wort);
- •Status post-partum or post-abortion within a period of 2 months before study start
- •Administration of investigational drugs within 2 months before screening
- •A history of (within 12 months) alcohol or drug abuse
研究者
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