EUCTR2008-004569-24-NL进行中（未招募）不适用
A double-blind, placebo-controlled, randomised, N=1 study to determine the effect of concomitant treatment with dehydroepiandrosterone (50 mg) on mood in women who experience mood disturbances during oral contraception-use. - ARC-MOOD
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
- •1.Women using oral contraceptives for at least 3 months prior to screening and aged 20-35 years (inclusive)
- •2.Report of mood disturbances, and attributing this to OC use as evidenced by in depth interview independently performed by two investigators
- •3.Regular menstrual cycles (24-35 days) prior to last start of OC use
- •4.Body mass index between (=) 18 and (=) 35 kg/m2
- •5.Good physical and mental health as judged by the Investigator determined by medical and gynaecological history, physical examination, clinical laboratory and vital signs
- •6.Willing to give informed consent in writing
- •For the subgroup, inclusion criterion 1 is not applicable and will be adapted to:
- •1.Women, aged 20-40 years (inclusive), using a non-hormonal contraceptive method for at least 3 months and willing to use an OC for 6 subsequent cycles
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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.Androgen therapy during the 6 months prior to screening
- •2.Use of non-oral hormonal contraception in the 3 months prior to the screening
- •3.Use of injectable contraceptives (e.g. cyclofem or DMPA) during the 6 months prior to the screening
- •4.Use within the past 3 months of implanted hormonal contraceptives Mirena® (progestin containing IUD) and Implanon® (subdermal implant delivering etonogestrel)
- •5.Intention to become pregnant during the study
- •6.Lactation and/or pregnancy in the previous 6 months prior to screening
- •7.History of/or current psychiatric disorder which is not related to the use of an OC
- •8.Treatment for any major psychiatric disorder in the previous 12 months or use of antidepressant medication prior to screening
- •9.Any clinically significant abnormality following review of medical and gynaecological history, clinical laboratory (haematology, biochemistry and androgen parameters) and physical examination and vital signs
- •10.Contraindications for contraceptive steroids:
- •-A history of, or existing thromboembolic, cardiovascular or cerebrovascular disorder
- •-A history of, or existing conditions predisposing to, or being prodromi of, a thrombosis
- •-A known defect in the blood coagulation system (e.g. deficiencies in AT-III, protein C, S, APC resistance and Factor V Leiden mutation)
- •-The presence of more than one risk factor for vascular disease (e.g. dyslipoproteinemia; diabetes mellitus; hyperhomocysteinemia; systemic lupus erythematosus; chronic inflammatory bowel disease; antiphospholipid antibodies; smoking; venous thromboembolism in sibling or parent below (<) the age of 50, or arterial disease in sibling or parent below (<) the age of 35; within 2 weeks after full remobilization following surgery)
- •-Hypertension, i.e. systolic blood pressure ? 140 mmHg and/or diastolic blood pressure ? 90 mmHg
- •-Disturbance of liver function: cholestatic jaundice, a history of jaundice of pregnancy or jaundice due to previous estrogen use, Rotor syndrome and Dubin-Johnson syndrome
- •-Known or suspected estrogen-dependent tumors or endometrial hyperplasia
- •-Undiagnosed vaginal bleeding
- •-Porphyria
- •-A history during pregnancy or previous estrogen-use of severe pruritus, herpes gestationis or deterioration of otosclerosis
- •11.Use of one or more of the following medications:
- •-Psychoactive drugs
- •-Antihypertensive drugs
- •-Sex steroids other than the current OC
- •-Use at present or within 30 days before start study medication:
- •hydantoins, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, troglitazone, felbamate, rifampicin, rifabutin, griseofulvin, nelfinavir, ritonavir and St. John’s wort (Hypericum perforatum)
- •12.Administration of any investigational drug within 3 months prior to screening
- •For the subgroup, exclusion criterion 2 is not applicable and will be adapted to:
- •2.Use of oral hormonal contraception in the 3 months prior to the screening
研究者
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