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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

NCT00915174 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2011-05-06

No results posted yet for this study

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

Interventions

DRUG

Neramexane

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

Sponsors & Collaborators

  • Merz Pharmaceuticals GmbH

    lead INDUSTRY

Principal Investigators

  • Medical Expert · Merz Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00915174 on ClinicalTrials.gov