Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation

Ovulation Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00254189
• Other study ID #: 0858A2-208
• Status: Completed
• Phase: Phase 2
• First received: November 11, 2005
• Last updated: May 17, 2006
• Start date: December 2002
• Est. completion date: October 2004

Study information

• Verified date: May 2006
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 36 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Ovulation

Intervention

Drug:
• Levonorgestrel

• Ethinyl Estradiol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.