IVR contraception, pharmacokinetic study
Primary objective: To investigate the pharmacokinetics (PK) of vaginal rings (test rings) releasing BAY 86-4977, i.e. a combination of EE and LNG, at two different doses of EE and LNG in healthy young women.
Secondary objective: To evaluate safety parameters of vaginal rings releasing BAY 86-4977, i.e. a combination of EE and LNG, at two different doses of EE and LNG in healthy young women.
- Healthy female subjects between 18 and 45 years of age with a body mass index between ≥18 and ≤ 31 kg/m2, usage of adequate non-hormonal birth control measures, non-smokers, no contraindications for hormonal contraceptives and vaginal administration
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal - Known or suspected malignant tumors, benign tumors of the liver, pituitary and adrenal gland (including after treatment) - Known or suspected liver disorders, including disturbances of bilirubin metabolism - Conditions / diseases known to occur or deteriorate with both pregnancy and combined oral contraceptive use - Pancreatitis associated with severe hypertriglyceridemia - Thrombophlebitis, venous / arterial thromboembolic diseases - Conditions that increase susceptibility to venous / arterial thromboembolic diseases - Presence or history of prodromata of thrombosis (e.g. transient ischemic attack, angina pectoris) - Diseases associated with adverse vascular events - Endogenous depression requiring antidepressant therapy within the last year prior to the first screening visit - Migraine - Known hypersensitivity to the study drugs (active substances or excipients of the preparations, ring material) - Known current thyroid disorders which require treatment (subjects with euthyroid struma who do not need any treatment can participate) - Intolerance to lactose requiring lactose-free diet (hereditary galactose intolerance, galactose-glucose malabsorption, lactase deficiency) - Regular use of medication other than hormonal contraceptives - Use of short-acting hormonal contraceptives (oral, dermal, vaginal) or an intra-uterine device (both hormone free and hormone releasing device) during the cycle before first study drug administration - Use of long-acting hormonal contraceptives (implants, 3 months injectables) within 40 weeks before first study drug administration - Recent or current use of medication which could interfere with the investigational products - Smokers - Suspicion of current drug, medicine or alcohol abuse - Regular daily consumption of more than 20 g of alcohol - Donation of blood or components of blood (e.g. plasma, thrombocytes) after signing the informed consent form - Clinically relevant findings in ECG, vital signs, screened laboratory parameters, physical examination, and gynecological examination - Undiagnosed vaginal bleeding - Clinical evidence of vulvo-vaginal infection - Cervical cytological smear classified higher than II according to Papanicolaou (grading I – V) - Anatomical alterations that may affect proper / convenient positioning of the ring (e.g.prolapse of the uterus, cysto- or rectocele) - Positive urine pregnancy test, urine drug screen - Presence of hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV) or human immune deficiency virus antibodies (anti-HIV 1+2) - Positive (confirmed) serologic test for syphilis - Positive testing for Chlamydia trachomatis, Neisseria gonorrhoeae
Randomized, open-label, parallel-group, multi-center study to evaluate the pharmacokinetics and safety of vaginal rings releasing different dosages of BAY 86-4977 (levonorgestrel [LNG]/ethinylestradiol [EE]) over 11 weeks in comparison to a single oral dose of Miranova (LNG/EE) followed by NuvaRing (etonogestrel [ENG]/EE) for 21 days in healthy young women