Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception - Full Text View

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00245921

Purpose

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.

Condition	Intervention	Phase
Contraception	Drug: Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg	Phase III

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Birth Control

Drug Information available for: Estradiol Estradiol 3-benzoate Ethinyl estradiol Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Levonorgestrel Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

To evaluate safety and contraceptive efficacy

Secondary Outcome Measures:

To evaluate the effects of this LNG/EE combination on bleeding profile, endometrial histology, hemostasis measures, hemoglobin levels, discontinuation rates, subject satisfaction, and cycle-related symptoms and work productivity at baseline.

Estimated Enrollment:	2000
Study Start Date:	March 2004

Eligibility

Ages Eligible for Study:	18 Years to 49 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245921

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	0858A2-313, 314, 320
Study First Received:	October 26, 2005
Last Updated:	May 17, 2006
ClinicalTrials.gov Identifier:	NCT00245921 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Wyeth:

contraception

Additional relevant MeSH terms:

Estrogens
Contraceptive Agents
Contraceptives, Oral
Estradiol valerate
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Ethinyl Estradiol
Reproductive Control Agents

Estradiol 17 beta-cypionate
Hormones
Estradiol
Pharmacologic Actions
Therapeutic Uses
Estradiol 3-benzoate
Levonorgestrel
Contraceptives, Oral, Synthetic
Polyestradiol phosphate

ClinicalTrials.gov processed this record on November 09, 2009