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

This study has been completed.
Sponsor:
Information provided by:
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00915174
First received: June 4, 2009
Last updated: May 5, 2011
Last verified: May 2011
  Purpose

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®)


Condition Intervention Phase
Healthy
Drug: Neramexane
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • 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) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: June 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Neramexane
    25 mg q.d., 3 days 2 x 25 mg b.i.d., 11 days
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00915174

Locations
Germany
AAIharma Deutschland GmbH & Co. KG
Neu Ulm, Bavaria, Germany, 89231
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Investigators
Study Director: Medical Expert MERZ Pharmaceuticals
  More Information

No publications provided

Responsible Party: Manager Public Disclosure, Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT00915174     History of Changes
Other Study ID Numbers: MRZ 92579/TI/1005
Study First Received: June 4, 2009
Last Updated: May 5, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Merz Pharmaceuticals GmbH:
drug-drug interaction study

Additional relevant MeSH terms:
Contraceptives, Oral
Drospirenone and ethinyl estradiol combination
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014