Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00245921
Collaborator
(none)
2,000
32
Study Details
Study Description
Brief Summary
To evaluate the safety and contraceptive efficacy of an oral contraceptive containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
A Phase 3, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg in a Continuous Daily Regimen for Oral Contraception
Study Start Date
:
Feb 1, 2003
Actual Primary Completion Date
:
Oct 1, 2005
Actual Study Completion Date
:
Oct 1, 2005
Outcome Measures
Primary Outcome Measures
- To evaluate safety and contraceptive efficacy []
Secondary Outcome Measures
- To evaluate the effects of this LNG/EE combination on bleeding profile, endometrial histology, hemostasis measures, hemoglobin levels, discontinuation rates, subject satisfaction, and cycle-related symptoms and work productivity at baseline. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Healthy women aged 18 to 49 years
-
Regular (21- to 35- day) menstrual cycles for the 3-month period preceding visit 1
-
Must be sexually active and at risk for becoming pregnant.
Exclusion Criteria:
-
Planned use of any other form of birth control other than the test article.
-
Depression requiring hospitalization or associated with suicidal ideation within the last 3 years.
-
High blood pressure (defined as elevated sitting blood pressure: > 140/90 mm Hg).
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
- Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00245921
Other Study ID Numbers:
- 0858A2-313, 314, 320
- B3211019, B3211020, B3211022
First Posted:
Oct 28, 2005
Last Update Posted:
Feb 8, 2013
Last Verified:
May 1, 2006
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer
Additional relevant MeSH terms: