Trial Condition(s):

Contraception

IVR contraception, pharmacokinetic study

Bayer Identifier:

16609

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2013-002276-41

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
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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
Status
LocationsStatus
Locations

CRS Clinical Research Services Berlin GmbH

Berlin, Germany, 13353

Status
Completed
 
Locations

Nuvisan GmbH

Neu-Ulm, Germany, 89231

Status
Completed
 

Trial Design