Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

NCT ID: NCT00245921

Last Updated: 2013-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2005-10-31

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.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

References

Reid RL, Fortier MP, Smith L, Mirkin S, Grubb GS, Constantine GD. Safety and bleeding profile of continuous levonorgestrel 90 mcg/ethinyl estradiol 20 mcg based on 2 years of clinical trial data in Canada. Contraception. 2010 Dec;82(6):497-502. doi: 10.1016/j.contraception.2010.06.002. Epub 2010 Jul 16.

Reference Type: DERIVED

PMID: 21074011 (View on PubMed)

Other Identifiers

B3211019, B3211020, B3211022

Identifier Type: OTHER

Identifier Source: secondary_id

0858A2-313, 314, 320

Identifier Type: -

Identifier Source: org_study_id