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Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception

Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00248963
Collaborator
(none)
600
Enrollment

Study Details

Study Description

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
  • Drug: Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg
 Phase 3

Study Design

Study Type:
Interventional
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 :
Oct 1, 2004

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

  • Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00248963
Other Study ID Numbers:
  • 0858A2-315
First Posted:
Nov 4, 2005
Last Update Posted:
May 19, 2006
Last Verified:
May 1, 2006
Keywords provided by , ,
Oral Contraceptive
Additional relevant MeSH terms:
Levonorgestrel
Ethinyl Estradiol
Estradiol

Study Results

No Results Posted as of May 19, 2006