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

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merz Pharmaceuticals GmbH
• Treatments: Drospirenone and ethinyl estradiol combination; Ethinyl Estradiol

Criteria

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