Clinical trial NCT00915174: Study to Evaluate the Effects of Neramexane on the Pharmacokinetics of a Combined Drospirenone/Ethinyl Estradiol Oral Contraceptive in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: drug-drug interaction study
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2009-06-05
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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®)


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

Primary outcomes:
measure: 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)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Neu Ulm
country: Germany
facility: AAIharma Deutschland GmbH & Co. KG
state: Bavaria
Study officials:
affiliation: Merz Pharmaceuticals
name: Medical Expert
role: STUDY_DIRECTOR
References: