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.
Investigators
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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