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

Information source: Merz Pharmaceuticals GmbH
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Neramexane (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Merz Pharmaceuticals GmbH

Official(s) and/or principal investigator(s):
Medical Expert, Study Director, Affiliation: MERZ Pharmaceuticals


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®)

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Primary outcome: 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)


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.


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


- 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

Locations and Contacts

AAIharma Deutschland GmbH & Co. KG, Neu Ulm, Bavaria 89231, Germany
Additional Information

Starting date: June 2009
Last updated: May 5, 2011

Page last updated: August 23, 2015

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