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

• Conditions: N92.0; Excessive and frequent menstruation with regular cycle

• Registration Number: DRKS00014982
• Lead Sponsor: Exeltis Germany GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-06
• Study Completion: 2019-05-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 103

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
11. Patients using intrauterine devices (IUD) or intrauterine systems (IUS)
12. Pregnancy and breastfeeding during the whole study duration
13. Patients who are postmenopausal
14. Smoker
15. Participation in any other trial 30 days before starting to use the GinoRing®

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
on-interventional retrospective study to evaluate menstrual bleeding profiles, tolerability and quality of life of women using the new vaginal ring GinoRing® delivering etonogestrel 0.120 mg and ethinylestradiol (EE) 0.015 mg per day <br>To assess retrospectively menstrual bleeding profiles and tolerability of women after usage of the contraceptive vaginal ring GinoRing® over an observation period of 6 months. Information about menstrual cycle like frequency, duration and intensity will be asked with the help of a patient questionnaire.

Secondary Outcome Measures

Name	Time	Method
To assess retrospectively menstrual bleeding profiles and tolerability of women after usage of the contraceptive vaginal ring GinoRing® over an observation period of 6 months. Information about menstrual cycle like frequency, duration and intensity will be asked with the help of a patient questionnaire.<br>1. To describe the quality of life and sexual wellbeing after using the vaginal ring for at least 6 months. This will be done with the help of a patient questionnaire. The first 6 months of application of the GinoRing® display the decisive observational period. <br>2. To evaluate the rate of occurred vaginal infections diagnosed by a health care professional and that needed medical treatment after usage of the vaginal ring. The rate will be determined by asking the patients with the help of a patient questionnaire after at least 6 months usage. If the patient is using the GinoRing® for more than 6 months, the first 6 months of usage have to be assessed.<br>