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Clinical Trials/DRKS00029349
DRKS00029349
Recruiting
未知

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

Chemo Group0 sites160 target enrollmentJune 22, 2022
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ConditionsN95.1Menopausal and female climacteric states

Overview

Phase
未知
Intervention
Not specified
Conditions
N95.1
Sponsor
Chemo Group
Enrollment
160
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 22, 2022
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Chemo Group

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Not specified

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