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Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception

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NCT00248963

Last updated on October 18, 2019
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Study Location
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Oral Contraceptive
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 who are willing to rely upon a combination birth
control pill as their only method of contraception.

- Women must be sexually active and at risk for becoming pregnant.

- Women must have had regular (21- to 35- day) menstrual cycles for the 3-month period
preceding study visit 1.

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

- High blood pressure

- Age greater then 34 and smoking more than 15 cigarettes per day.

- Depression requiring hospitalization or associated with suicidal ideation within the
last 3 years.

NCT00248963
Pfizer
Completed
Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception

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[email protected]

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Descriptive Information
Brief Title  ICMJE Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception
Official Title  ICMJE A Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Levonorgestrel 90 Mg and Ethinyl Estradiol 20 Mg in a Continuous 28-Day Regimen for Oral Contraception Versus a Cyclic 21-Day Regimen Oral Contraceptive
Brief SummaryTo evaluate the contraceptive efficacy of an oral contraceptive containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen and to evaluate the safety compared to LNG 100 mg/EE 20 mg for 21 days followed by a 7-day hormone-free interval in a cyclic regimen.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Condition  ICMJE Oral Contraceptive
Intervention  ICMJE Drug: Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   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: November 2, 2005)		600
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE October 2004
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy women aged 18 to 49 years who are willing to rely upon a combination birth control pill as their only method of contraception.
  • Women must be sexually active and at risk for becoming pregnant.
  • Women must have had regular (21- to 35- day) menstrual cycles for the 3-month period preceding study visit 1.

Exclusion Criteria:

  • High blood pressure
  • Age greater then 34 and smoking more than 15 cigarettes per day.
  • Depression requiring hospitalization or associated with suicidal ideation within the last 3 years.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT00248963
Other Study ID Numbers  ICMJE 0858A2-315
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
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 AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateMay 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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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