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Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception

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ClinicalTrials.gov Identifier: NCT00248963
Recruitment Status : Completed
First Posted : November 4, 2005
Last Update Posted : May 19, 2006
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Oral Contraceptive Drug: Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: 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
Study Completion Date : October 2004





Primary Outcome Measures :
  1. To evaluate the contraceptive efficacy of an OC containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen and 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

Secondary Outcome Measures :
  1. To evaluate the effects on vaginal bleeding profile, hemostatic balance, lipid, carbohydrate, bone metabolism measures, hemoglobin levels, discontinuation rates, compliance with respect to pill taking, subject satisfaction


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00248963


Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
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ClinicalTrials.gov Identifier: NCT00248963    
Other Study ID Numbers: 0858A2-315
First Posted: November 4, 2005    Key Record Dates
Last Update Posted: May 19, 2006
Last Verified: May 2006
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Oral Contraceptive
Additional relevant MeSH terms:
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Levonorgestrel
Estradiol
Ethinyl Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral