Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ovulation
Intervention: Levonorgestrel (Drug); Ethinyl Estradiol (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Summary
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.
Clinical Details
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.
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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: 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.
Eligibility
Minimum age: N/A.
Maximum age: 36 Years.
Gender(s): Female.
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.
Locations and Contacts
Additional Information
Starting date: December 2002
Ending date: October 2004
Last updated: May 17, 2006
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