Trials / Completed
CompletedNCT00915174
Study to Evaluate the Effects of Neramexane on the Pharmacokinetics of a Combined Drospirenone/Ethinyl Estradiol Oral Contraceptive in Healthy Female Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Merz Pharmaceuticals GmbH · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Neramexane | 25 mg q.d., 3 days 2 x 25 mg b.i.d., 11 days |
Timeline
- Start date
- 2009-06-01
- Primary completion
- 2009-11-01
- Completion
- 2009-11-01
- First posted
- 2009-06-05
- Last updated
- 2011-05-06
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00915174. Inclusion in this directory is not an endorsement.