Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation
Phase 2
Completed
- Conditions
- Ovulation
- Registration Number
- NCT00254189
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms does Levonorgestrel 90mg and Ethinyl Estradiol 20mg use to inhibit ovulation in a continuous regimen?
How does the continuous oral regimen of Levonorgestrel 90mg and Ethinyl Estradiol 20mg compare to standard cyclic contraceptive regimens in ovulation suppression?
Are there specific biomarkers that correlate with the effectiveness of Levonorgestrel and Ethinyl Estradiol in preventing ovulation during extended cycles?
What are the potential adverse events associated with long-term use of Levonorgestrel 90mg and Ethinyl Estradiol 20mg in continuous contraceptive regimens?
How do combination hormonal contraceptives like Levonorgestrel and Ethinyl Estradiol influence the hypothalamic-pituitary-ovarian axis in ovulation inhibition?