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

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 36

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

Name	Time	Method
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

Name

Time

Method

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

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

Recruitment & Eligibility

Study & Design

Trial Locations

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