Status:
COMPLETED
Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Ovulation
Eligibility:
FEMALE
Up to 36 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
End Date :
October 1 2004
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00254189
Start Date
December 1 2002
End Date
October 1 2004
Last Update
May 19 2006
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