Trial Condition(s):
Contraception
IVR contraception, pharmacokinetic study
Bayer Identifier:
16609
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Study Completed
Trial Purpose
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.
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Trial Summary
Enrollment Goal
78
Trial Dates
Phase
1
Could I receive a placebo?
No
Products
Minisiston/Monostep (EE30/LNG, BAY86-4977)
Accepts Healthy Volunteers
Yes
Where to Participate
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Locations
| Locations | |
|---|---|
Locations CRS Clinical Research Services Berlin GmbH Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nuvisan GmbH Neu-Ulm, Germany, 89231 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- CavAverage concentration, calculated over the complete wearing period of the ring, of total and unbound LNG and EE after test rings and of EE after NuvaRingTimeframe: Test rings 1 and 2: prior to insertion of vaginal ring and up to 81 days. For NuvaRing: prior to insertion of NuvaRing and up to 25 days
- Cav,ssEstimated average concentration of total and unbound LNG in steady state after Miranova administrationTimeframe: Pre-dose and up to 96 h post-dose
Secondary Outcome
- CmaxMaximum observed drug concentration, in measured matrix, of EE and total and unbound LNG post insertion of test ringTimeframe: Prior to insertion of vaginal test ring (1/2) and up to 81 days post insertion
- CminMinimum observed serum concentration of EE and total and unbound LNG post insertion of test ringTimeframe: Prior to insertion of vaginal test ring (1/2) and up to 81 days post insertion
- tmaxTime to reach Cmax of EE and total and unbound LNG post insertion of test ringTimeframe: Prior to insertion of vaginal test ring (1/2) and up to 81 days post insertion
- λApparent rate constant, calculated from the slope of a log-linear regression of the unweighted data during the wearing period of test ring, for EE and total and unbound LNGTimeframe: Prior to insertion of vaginal test ring (1/2) and up to 81 days post insertion
- C49dConcentration of EE and total and unbound LNG on day 49 post insertion of test ringTimeframe: Day 49 post insertion of test ring (1/2)
- C52dConcentration of EE and total and unbound LNG on day 52 post insertion of test ringTimeframe: Day 52 post insertion of test ring (1/2)
- C77dConcentration of EE and total and unbound LNG on day 77 post insertion of test ringTimeframe: Day 77 post insertion of test ring (1/2)
- Cmax/C77dMaximum observed drug concentration in measured matrix divided by drug concentration (EE and total and unbound LNG) on day 77 post insertion of test ringTimeframe: Prior to insertion of vaginal test ring (1/2) and up to 81 days post insertion
- Cav,35-42dAverage concentration of EE and total and unbound LNG calculated between days 35 and 42 post insertion of test ringTimeframe: From 35 to 42 days post insertion of test ring (1/2)
- Cav,70-77dAverage concentration of EE and total and unbound LNG calculated between days 70 and 77 post insertion of test ringTimeframe: From 70 to 77 days post insertion of test ring (1/2)
- Number of participants with adverse eventsTimeframe: Approximately 21-23 weeks for subjects on test rings and approximately 17-19 weeks for subjects on Miranova followed by NuvaRing
Additional Information
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