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Clinical Trial Name - Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation
| Original Study ID : 0858A2-208 |
| NCT ID : NCT00254189 |
| Brief Title : Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation |
| 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. |
| 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. |
| Source : Wyeth |
| Overall Status : Completed |
| Start Date : December 2002 |
| End Date : October 2004 |
| Completion Date : October 2004 |
| Official Title : Phase 2 |
| Phase : Interventional |
| Study Design : Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Enrollment : 60 |
| Verification Date : May 2006 |
| First Received Date : November 11, 2005 |
| Trial Eligibility |
| 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. |
| Gender : Female |
| Minimum Age : N/A |
| Maximum Age : 36 Years |
| Healthy Volunteers : Accepts He |
| OutComes |
| Primary OutComes |
| Measure : 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 |
| Measure : 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 |
| Type : Drug |
| Name : Levonorgestrel |
| Type : Drug |
| Name : Ethinyl Estradiol |
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