NL-OMON52418招募中3 期
Open-label randomized controlled trial for the effects of continuous ethinylestradiol/levonorgestrel (30/150 µg/day) compared with vitamin E (400 IU/day) in the treatment of menstrually-related migraine and migraine during perimenopause - WHAT! - RCT
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 360
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •- menstrually-related migraine OR migraine in the early menopausal transition
- •- age >= 18
- •- demonstrated at least 80% compliance with eDiary during baseline period
- •- no or stable for at least two months on prophylactic medication
排除标准
- •- Migraine with aura
- •- Chronic migraine with 15 or more headache days per month/with 8 or more
- •migraine days per month
- •- Medication-overuse headache (ICHD-3 criteria)
- •- Women who are breastfeeding, pregnant, or planning to become pregnant
- •- Oral contraceptive use and not willing to undergo washout period (stop for
- •two consecutive months)
- •- Vitamin E use at start of the study
- •- Use of other sex hormone containing treatments
- •- Increased risk of VTE: history of VTE or thrombophlebitis, hereditary
- •predisposition for VTE (APC resistance, protein C or S deficiency, antithrombin
- •deficiency), VTE in first-degree family member with young age, long term
- •immobilisation
- •- Increased risk of ATE: history of ATE, hereditary predisposition for ATE
- •(hyperhomocysteinemia, antiphospholipid antibodies), ATE in first-degree family
- •member with young age, diabetes mellitus, total cholesterol >= 6.5
- •- Other contraindication for oral contraceptives: liver malignancy,
- •schistosomiasis, HIV/aids, use of immunosuppressives, tuberculosis,
- •sex-hormone-dependent malignancies (breast, endometrial or ovary carcinomas),
- •pancreatitis, vaginal bleeding with unknown cause, other diseases that can
- •influence vessels (malignancies, heart valve disorders, atrial fibrillation,
- •SLE, haemolytic uremic syndrome, chronic inflammatory bowel disease, sickle
- •cell disease)
- •- Contraindication for vitamin E: vitamin K deficiency
- •- Hypersensitivity for any of the compounds in oral contraceptive or vitamin E
- •- Spontaneous postmenopausal status (menstrual bleedings have ceased for 12
- •consecutive months)
- •- Iatrogenic postmenopausal status
- •- Inability to complete the electronic diary in an accurate manner
- •- Any serious illness that can compromise study participation
研究者
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