Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation - Full Text View

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00254189

Purpose

To determine the ability of a monophasic oral contraceptives ("OC") regimen of Levonorgestrel ("LNG") 90 mg and Ethinyl Estradiol ("EE") 20 mg to inhibit ovulation during 84 days of continuous therapy.

Condition	Intervention	Phase
Ovulation	Drug: Levonorgestrel Drug: Ethinyl Estradiol	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Single Center, Open-Label Study to Evaluate the Effects on Ovulation of Levonorgestrel 90mg and Ethinyl Estradiol 20mg in a Daily, Continuous, Oral Regimen.

Resource links provided by NLM:

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 determine the ability of a monophasic oral contraceptive (OC) regimen of Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg to inhibit ovulation during 84 days of continuous therapy.

Secondary Outcome Measures:

To assess the safety profile. To assess the ovarian activity, as measured by the Hoogland and Skouby 6-point grading system, during 84 days of continuous therapy. To evaluate the time to return of ovulation after cessation of treatment.

Estimated Enrollment:	60
Study Start Date:	December 2002
Estimated Study Completion Date:	October 2004

Eligibility

Ages Eligible for Study:	up to 36 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy women of legal age of consent who are willing to use a combination OC.
Subjects must be under the age of 36 at the time of enrollment (visit 3).
Subjects must have had regular (24 to 32 day) menstrual cycles for the 3-month period preceding entry into the pretreatment observation cycle, excluding postabortal and nonnursing postpartum subjects. Postabortal and nonnursing postpartum subjects must have completed at least 1 regular (24 to 32 day) spontaneous menstrual cycle before entry into the pretreatment observation cycle. The pretreatment observation cycle for all subjects will begin on day 1 of the subsequent spontaneous menses.

Other inclusions apply.

Exclusion Criteria:

A history or the presence of any of the following will prevent enrollment:

Thrombophlebitis, thrombosis, or thromboembolic disorders.
Deep vein thrombosis.
Pulmonary embolism.

Other exclusions apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254189

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided by Wyeth

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Archer DF, Kovalevsky G, Ballagh SA, Grubb GS. Ovarian activity and safety of a novel levonorgestrel/ethinyl estradiol continuous oral contraceptive regimen. Contraception. 2009 Sep;80(3):245-53. Epub 2009 May 2.

Study ID Numbers:	0858A2-208
Study First Received:	November 11, 2005
Last Updated:	May 17, 2006
ClinicalTrials.gov Identifier:	NCT00254189 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Ovulation
Oral Contraceptive

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 February 08, 2010