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Clinical Trials/DRKS00014982
DRKS00014982
Completed
Not Applicable

on-interventional retrospective study to evaluate the menstrual cycle profiles and quality of life of women after the use of the new vaginal ring GinoRing® delivering 0.120mg etonogestrel and 0.015mg ethinylestradiol per day - Evol Study

Exeltis Germany GmbH0 sites103 target enrollmentAugust 6, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
N92.0
Sponsor
Exeltis Germany GmbH
Enrollment
103
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 6, 2018
End Date
May 9, 2019
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
Exeltis Germany GmbH

Eligibility Criteria

Inclusion Criteria

  • 1\. Female patients, age \= 18 and \= 45 years
  • 2\. Usage of the GinoRing® as contraceptive method for at least 6 months
  • 3\. Signed informed consent

Exclusion Criteria

  • 1\. Current BMI \> 30 kg/m2
  • 2\. Patients with severe acute or chronic diseases (e.g. pancreatitis, hypertriglyceridemia, liver disease, benign or malign liver tumor, malign sex\-hormone dependent diseases of genitals or breasts)
  • 3\. Migraine
  • 4\. Intake of herbal medicines which induce microsomal enzymes, especially cytochrome\-P450\-enzyme, e.g. Phenytoin, Phenobarbital, Primidon, Bosentan, Carbamazepin, Rifampicin, Topiramat, Felbamat, Griseofulvin, a few HIV protease inhibitors (e.g. Ritonavir), and non\-nucleosidic Reverse\-Transcriptase\-Inhibitors (e.g. Efavirenz) as well as preparations of Aaron´s beard.
  • 5\. History of cardiovascular events
  • 6\. Advanced hypertension or diabetes
  • 7\. Presence or known risk of venous or arterial thromboembolism
  • 8\. Known hypersensitivity to components of GinoRing®
  • 9\. Undiagnosed abnormal vaginal bleeding
  • 10\. Use of drugs containing Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir during and two weeks before start of the study

Outcomes

Primary Outcomes

Not specified

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