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Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation

Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
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 is now a wholly owned subsidiary of Pfizer

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer

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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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
Last updated: May 17, 2006

Page last updated: August 23, 2015

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