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临床试验/DRKS00029349
DRKS00029349招募中未知

Improvement of different menopausal symptoms under the use of the nutritional menopausal product Exelvit Menopausia - Menoxel -1

Chemo Group0 个研究点目标入组 160 人开始时间: 2022年6月22日最近更新:
适应症

试验速览

阶段
未知
状态
招募中
发起方
入组人数
160

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
N/a: Single Arm Study
盲法
Open (masking not used)

入排标准

年龄范围
50 Years 至 90 Years(—)
性别
Female

入选标准

  • 1. Female patients, age = 50 years and being menopausal according to clinical symptoms
  • 2. FSH (> 50 mIU/mL) and Estradiol (< 30 pg/mL)
  • 3. Written informed Consent

排除标准

  • 1. Current BMI > 35 kg/m2
  • 2. Patients with severe acute or chronic diseases (e.g. pancreatitis, hypertriglyceridemia, liver disease, malign or benign tumor of the liver, malign sex-hormone-dependent diseases of the genital or the breast)
  • 3. Migraine with Aura
  • 4. Intake of drugs, which induce microsomal enzymes, especially cytochrome-P450, e.g. phenytoine, phenobarbital, pyrimidon, bosentan, carbamazepin, rifampicin, topiramate, felbamate, griseofulvine, some HIV protease inhibitors (e.g. ritonavir) und non-nucleosidic inhibitors of reverse transciptase (e.g. efavirenz) and androgen receptor (AR) antagonists (e.g. enzalutamide).
  • 5. History of cardiocascular disease
  • 6. Advanced high blood pressure or diabetes mellitus
  • 7. Existence or known risk for venous or arterial thromboembolism
  • 8. Non-diagnosed abnormous vaginal bleeding
  • 9. Use of drugs containing Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir during the study period and two weeks in advance
  • 10. Pregnancy and Breast feeding during the study period
  • 11. Allergy to one of the compounds of the product
  • 12. Concomitant use of other nutritional products or female sexual hormones during the study and 8 weeks before

研究者

发起方
Chemo Group

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