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.
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2002
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 11, 2005
CompletedFirst Posted
Study publicly available on registry
November 15, 2005
CompletedMay 19, 2006
May 1, 2006
November 11, 2005
May 17, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- A history or the presence of any of the following will prevent enrollment:
- Thrombophlebitis, thrombosis, or thromboembolic disorders.
- Deep vein thrombosis.
- Pulmonary embolism.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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. doi: 10.1016/j.contraception.2009.03.006. Epub 2009 May 2.
PMID: 19698816DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 11, 2005
First Posted
November 15, 2005
Study Start
December 1, 2002
Study Completion
October 1, 2004
Last Updated
May 19, 2006
Record last verified: 2006-05