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Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception

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NCT00248963

Last updated on May 12, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
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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Pfizer Clinical Trials Contact Center

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[email protected]

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Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception
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
To 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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Oral Contraceptive
Drug: Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
October 2004
Not Provided

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.
Sexes Eligible for Study: Female
18 Years to 49 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00248963
0858A2-315
Not Provided
Not Provided
Not Provided
Not Provided
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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