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| Sponsor: | Merz Pharmaceuticals GmbH |
|---|---|
| Information provided by: | Merz Pharmaceuticals GmbH |
| ClinicalTrials.gov Identifier: | NCT00915174 |
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 I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) |
| 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) |
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| 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 |
|
drug-drug interaction study |
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Contraceptives, Oral Drospirenone and ethinyl estradiol combination Contraceptive Agents, Female Contraceptive Agents |
Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |