check_circleStudy Completed

Contraception

Bayer Identifier:

16609

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2013-002276-41

EU CT Number:

Not Available
IVR contraception, pharmacokinetic study

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.

Key Participants Requirements

Sex

N/A

Age

18 - 45 Years
  • - 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

Trial summary

Enrollment Goal
78
Trial Dates
October 2013 - September 2014
Phase
Phase 1
Could I Receive a placebo
No
Products
Minisiston/Monostep (EE30/LNG, BAY86-4977)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
CRS Clinical Research Services Berlin GmbHBerlin, 13353, Germany
Completed
Nuvisan GmbHNeu-Ulm, 89231, Germany

Primary Outcome

  • Cav
    Average concentration, calculated over the complete wearing period of the ring, of total and unbound LNG and EE after test rings and of EE after NuvaRing
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No
  • Cav,ss
    Estimated average concentration of total and unbound LNG in steady state after Miranova administration
    date_rangeTime Frame:
    Pre-dose and up to 96 h post-dose
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Cmax
    Maximum observed drug concentration, in measured matrix, of EE and total and unbound LNG post insertion of test ring
    date_rangeTime Frame:
    Prior to insertion of vaginal test ring (1/2) and up to 81 days post insertion
    enhanced_encryption
    Safety Issue:
    No
  • Cmin
    Minimum observed serum concentration of EE and total and unbound LNG post insertion of test ring
    date_rangeTime Frame:
    Prior to insertion of vaginal test ring (1/2) and up to 81 days post insertion
    enhanced_encryption
    Safety Issue:
    No
  • tmax
    Time to reach Cmax of EE and total and unbound LNG post insertion of test ring
    date_rangeTime Frame:
    Prior to insertion of vaginal test ring (1/2) and up to 81 days post insertion
    enhanced_encryption
    Safety Issue:
    No
  • λ
    Apparent 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 LNG
    date_rangeTime Frame:
    Prior to insertion of vaginal test ring (1/2) and up to 81 days post insertion
    enhanced_encryption
    Safety Issue:
    No
  • C49d
    Concentration of EE and total and unbound LNG on day 49 post insertion of test ring
    date_rangeTime Frame:
    Day 49 post insertion of test ring (1/2)
    enhanced_encryption
    Safety Issue:
    No
  • C52d
    Concentration of EE and total and unbound LNG on day 52 post insertion of test ring
    date_rangeTime Frame:
    Day 52 post insertion of test ring (1/2)
    enhanced_encryption
    Safety Issue:
    No
  • C77d
    Concentration of EE and total and unbound LNG on day 77 post insertion of test ring
    date_rangeTime Frame:
    Day 77 post insertion of test ring (1/2)
    enhanced_encryption
    Safety Issue:
    No
  • Cmax/C77d
    Maximum observed drug concentration in measured matrix divided by drug concentration (EE and total and unbound LNG) on day 77 post insertion of test ring
    date_rangeTime Frame:
    Prior to insertion of vaginal test ring (1/2) and up to 81 days post insertion
    enhanced_encryption
    Safety Issue:
    No
  • Cav,35-42d
    Average concentration of EE and total and unbound LNG calculated between days 35 and 42 post insertion of test ring
    date_rangeTime Frame:
    From 35 to 42 days post insertion of test ring (1/2)
    enhanced_encryption
    Safety Issue:
    No
  • Cav,70-77d
    Average concentration of EE and total and unbound LNG calculated between days 70 and 77 post insertion of test ring
    date_rangeTime Frame:
    From 70 to 77 days post insertion of test ring (1/2)
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with adverse events
    date_rangeTime Frame:
    Approximately 21-23 weeks for subjects on test rings and approximately 17-19 weeks for subjects on Miranova followed by NuvaRing
    enhanced_encryption
    Safety Issue:
    Yes

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

Additional Information

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