Study 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

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

Trial Dates

October 2013 - September 2014

Phase

Phase 1

Could I Receive a placebo

Products

Minisiston/Monostep (EE30/LNG, BAY86-4977)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	CRS Clinical Research Services Berlin GmbH	Berlin, 13353, Germany
Completed	Nuvisan GmbH	Neu-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
Time 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
Safety Issue:
No
Cav,ss
Estimated average concentration of total and unbound LNG in steady state after Miranova administration
Time Frame:
Pre-dose and up to 96 h post-dose
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
Time Frame:
Prior to insertion of vaginal test ring (1/2) and up to 81 days post insertion
Safety Issue:
No
Cmin
Minimum observed serum concentration of EE and total and unbound LNG post insertion of test ring
Time Frame:
Prior to insertion of vaginal test ring (1/2) and up to 81 days post insertion
Safety Issue:
No
tmax
Time to reach Cmax of EE and total and unbound LNG post insertion of test ring
Time Frame:
Prior to insertion of vaginal test ring (1/2) and up to 81 days post insertion
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
Time Frame:
Prior to insertion of vaginal test ring (1/2) and up to 81 days post insertion
Safety Issue:
No
C49d
Concentration of EE and total and unbound LNG on day 49 post insertion of test ring
Time Frame:
Day 49 post insertion of test ring (1/2)
Safety Issue:
No
C52d
Concentration of EE and total and unbound LNG on day 52 post insertion of test ring
Time Frame:
Day 52 post insertion of test ring (1/2)
Safety Issue:
No
C77d
Concentration of EE and total and unbound LNG on day 77 post insertion of test ring
Time Frame:
Day 77 post insertion of test ring (1/2)
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
Time Frame:
Prior to insertion of vaginal test ring (1/2) and up to 81 days post insertion
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
Time Frame:
From 35 to 42 days post insertion of test ring (1/2)
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
Time Frame:
From 70 to 77 days post insertion of test ring (1/2)
Safety Issue:
No
Number of participants with adverse events
Time Frame:
Approximately 21-23 weeks for subjects on test rings and approximately 17-19 weeks for subjects on Miranova followed by NuvaRing
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

Additional Information

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