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Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00254189
First Posted: November 15, 2005
Last Update Posted: May 19, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 36 Years   (Child, Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00254189


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00254189     History of Changes
Other Study ID Numbers: 0858A2-208
First Submitted: November 11, 2005
First Posted: November 15, 2005
Last Update Posted: May 19, 2006
Last Verified: May 2006

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

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptives, Oral, Combined