Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

This study has been completed.

First Received on October 26, 2005. Last Updated on May 17, 2006 History of Changes

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Educational/Counseling/Training
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 is now a wholly owned subsidiary of Pfizer:

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 is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

Medical Monitor

Wyeth is now a wholly owned subsidiary of Pfizer

More Information

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Reid RL, Fortier MP, Smith L, Mirkin S, Grubb GS, Constantine GD. Safety and bleeding profile of continuous levonorgestrel 90 mcg/ethinyl estradiol 20 mcg based on 2 years of clinical trial data in Canada. Contraception. 2010 Dec;82(6):497-502. Epub 2010 Jul 16.

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

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

contraception

Additional relevant MeSH terms:

Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Levonorgestrel
Estrogens
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on February 09, 2012