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Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

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NCT00245921

Last updated on May 12, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
C[email protected]
Related Links
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).

NCT00245921
Pfizer
Completed
Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

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

Pfizer Clinical Trials Contact Center

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[email protected]

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Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Contraception
Drug: Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg
Not Provided
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.
 
Completed
2000
October 2005
October 2005   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: Female
18 Years to 49 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00245921
0858A2-313, 314, 320
B3211019, B3211020, B3211022 ( Other Identifier: Pfizer )
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
May 2006

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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