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

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT00915174
• Lead Sponsor: Merz Pharmaceuticals GmbH

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®)

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-04
• Study First Submitted QC: 2009-06-04
• Study First Posted: 2009-06-05
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-05
• Last Update Posted: 2011-05-06

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Trial Locations

Locations (1)

AAIharma Deutschland GmbH & Co. KG; 🇩🇪 Neu Ulm, Bavaria, Germany