| Trial ID: | L4141 |
| Source ID: | NCT00504816
|
| Associated Drug: |
Gsk189075
|
| Title: |
A Study of the Effects of GSK189075 on PK Profiles of an Oral Contraceptive Pill When Given to Healthy Female Volunteers
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: GSK189075|DRUG: Brevicon
|
| Outcome Measures: |
Primary: Oral contraceptive pill (OC) drug levels, over 24h starting on Day 14|blood hormone levels, on Days 1, 11-14, & 21 of Periods 1 (OC alone) & 3 (OC plus GSK study drug). Period 2 is GSK drug study alone. | Secondary: Adverse events, all visits after study drug|ECGs, Clinical laboratory tests, screening & follow-up|vital signs, screening;Day 13, Period 1 & 3; Follow-up
|
| Sponsor/Collaborators: |
Sponsor: GlaxoSmithKline
|
| Gender: |
FEMALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
22
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2007-04
|
| Completion Date: |
2008-04
|
| Results First Posted: |
|
| Last Update Posted: |
2012-06-04
|
| Locations: |
GSK Investigational Site, Miramar, Florida, 33025, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00504816
|
