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

NCT ID: NCT00915174

Last Updated: 2011-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2009-11-30

Brief 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®)

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: DOUBLE

Interventions

Neramexane

25 mg q.d., 3 days 2 x 25 mg b.i.d., 11 days

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merz Pharmaceuticals GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Merz Pharmaceuticals GmbH

Principal Investigators

Medical Expert

Role: STUDY_DIRECTOR

Merz Pharmaceuticals

Locations

AAIharma Deutschland GmbH & Co. KG

Neu-Ulm, Bavaria, Germany

Countries

Germany

Other Identifiers

MRZ 92579/TI/1005

Identifier Type: -

Identifier Source: org_study_id