Overview
Study to Evaluate the Effects of Neramexane on the Pharmacokinetics of a Combined Drospirenone/Ethinyl Estradiol Oral Contraceptive in Healthy Female Subjects
Status:
Completed
Completed
Trial end date:
2009-11-01
2009-11-01
Target enrollment:
0
0
Participant gender:
Female
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 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Merz Pharmaceuticals GmbHTreatments:
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