Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

Back to Search
Print
Bookmark Trial

NCT00245921

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Contraception
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-49 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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).

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now
pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
Learn more ›

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

ContraceptionStudy of Self or Clinic Administration of DepoProvera
NCT01019369
  1. New York, New York
Female
18 Years+
years
MULTIPLE SITES
ContraceptionPharmacist-Administered Injections for Contraception
NCT00775047
  1. Chapel Hill, North Carolina
Female
18 Years+
years
MULTIPLE SITES
ContraceptionDepo Provera Self-Administration Study: Putting a Patient-Centered Practice to the Test at Planned Parenthood
NCT02509767
  1. Morristown, New Jersey
  2. Houston, Texas
Female
15 Years+
years
MULTIPLE SITES
ContraceptionStudy Evaluating the Bioequivalence of Levonorgestrel/Ethinyl Estradiol Combinations in Cycling Women
NCT00447863
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Contraception
Intervention  ICMJE Drug: Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: October 26, 2005)		2000
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2005
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00245921
Other Study ID Numbers  ICMJE 0858A2-313, 314, 320
B3211019, B3211020, B3211022 ( Other Identifier: Pfizer )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP