Study to Evaluate the Effects of Neramexane on the Pharmacokinetics of a Combined Drospirenone/Ethinyl Estradiol Oral Contraceptive in Healthy Female Subjects

Study Overview
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Brief Summary
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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 of concomitant repeated dose treatments of Neramexane and a fixed-combinational DRSP- and EE-containing oral contraceptive [OC] (Yasmin®)

Conditions
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Healthy

Intervention / Treatment
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* Drug: Neramexane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Neramexane|25 mg q.d., 3 days 2 x 25 mg b.i.d., 11 days|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under Curve within a dose interval (AUC, 0-tau) and Maximum Plasma Concentration at Steady State (Cmax) of Drospirenone (DRSP) and Ethinyl Estradiol (EE) |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug-drug interaction study