Status:
COMPLETED
Study to Evaluate the Effects of Neramexane on the Pharmacokinetics of a Combined Drospirenone/Ethinyl Estradiol Oral Contraceptive in Healthy Female Subjects
Lead Sponsor:
Merz Pharmaceuticals GmbH
Conditions:
Healthy
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
Primary: To assess the effects of repeated dose of Neramexane on the steady-state pharmacokinetics of Drospirenone \[DRSP\] and Ethinyl Estradiol \[EE\] Secondary: To assess safety and tolerability...
Eligibility Criteria
Inclusion
- Healthy adult female subject of child bearing potential (including subject with tubal ligation), white origin, who is able to read, to write and fully understand German language
- Aged 18 to 45 years (both inclusive)
- BMI of 18-28 kg/m2 and a body weight of 50-90 kg (both inclusive)
- The subject is required
- To have taken a DRSP/EE- containing OC for at least two dosing cycles
- To agree using reliable non hormonal birth control methods from Day -1 of study Period 1 until the Final Examination (e.g. non-hormonal IUD, double barrier method \[e.g. condom with spermicide or diaphragm with spermicide\], sexual abstinence). Women with tubal ligation or sterilized partner do not need an additional birth control method
- Willing and able to provide written informed consent after having been informed of the requirements and the restrictions of the study
Exclusion
- History of clinically relevant allergy or known hypersensitivity to Neramexane/Memantine/ Amantadine and their derivatives
- Hypersensitivity to Quinine
- History of clinically relevant allergy or known hypersensitivity to any inactive ingredient in any of the used study medications (Neramexane, Yasmin®, Placebo) or tool substance
- History of clinically relevant allergy or known hypersensitivity to DRSP/EE
- Clinically relevant findings on the mammae or genital examination, PAP smear ≥ III
- Any contraindications against the oral contraceptive:
- present or past venous thromboses (deep vein thrombosis, pulmonary embolism);
- present or past arterial thromboses (e.g. myocardial infarction) or their prodromal stages (e.g. angina pectoris and transitory ischaemic attack);
- present or past cerebrovascular insult;
- presence of a serious risk factor or several risk factors for an arterial thrombosis: diabetes mellitus with vascular changes, severe hypertension, severe lipid metabolism disturbance;
- known or suspected genetic or acquired predisposition for venous or arterial thromboses like APC resistance,
- known or suspected genetic lack of antithrombin III, lack of protein C, lack of protein S, hyperhomocysteinaemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulants);
- present or past pancreatitis if this is accompanied by severe hypertriglyceridaemia;
- present or past severe hepatic disease as long as the liver function tests have not normalized;
- severe renal insufficiency or acute renal failure;
- present or past hepatic tumors (benign or malign);
- known or suspected sexual hormone dependent, malign tumors (e.g. of the genital organs or the mamma);
- diagnostic not clarified vaginal bleedings;
- anamnesis of migraine with focal neurologic symptoms;
- known hereditary angioedema
- Exposure to another investigational agent within the last two months before Day 1 of Period 1
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00915174
Start Date
June 1 2009
End Date
November 1 2009
Last Update
May 6 2011
Active Locations (1)
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1
AAIharma Deutschland GmbH & Co. KG
Neu-Ulm, Bavaria, Germany, 89231