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Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00254189
First received: November 11, 2005
Last updated: May 17, 2006
Last verified: May 2006
History of Changes

November 11, 2005
May 17, 2006
December 2002
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00254189 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation
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.

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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovulation
  • Drug: Levonorgestrel
  • Drug: Ethinyl Estradiol
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
October 2004
Not Provided

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.
Female
up to 36 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00254189
0858A2-208
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP