NCT00245921

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2003

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2005

Completed
Last Updated

February 8, 2013

Status Verified

May 1, 2006

Enrollment Period

2.7 years

First QC Date

October 26, 2005

Last Update Submit

February 7, 2013

Conditions

Contraception

Keywords

contraception

Outcome Measures

Primary Outcomes (1)

  • To evaluate safety and contraceptive efficacy

Secondary Outcomes (1)

  • 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.

Interventions

Levonorgestrel 90 mg/Ethinyl Estradiol 20 mgDRUG

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 21074011DERIVED

MeSH Terms

Interventions

LevonorgestrelEthinyl Estradiol

Intervention Hierarchy (Ancestors)

NorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsNorpregnatrienesEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2005

First Posted

October 28, 2005

Study Start

February 1, 2003

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

February 8, 2013

Record last verified: 2006-05