NCT00570440

Continuous Use of COCs

Continuous Versus Cyclic Use of Combined Oral Contraceptive Pills

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 362 (estimated)
• Sponsor: FHI 360 · Academic / Other
• Sex: Female
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

Summary

The primary objective is to determine if continuous COC use leads to higher continuation rates over 12 months of follow up than use of the standard 28-day COC regimen.

Detailed description

Family Health International has recently initiated a USAID funded study to investigate the pregnancy rates, continuation rates, and acceptability of COCs in women taking COCs by the 21/7 cyclic regimen compared with the continuous use of COCs with bleeding-signaled hormone-free intervals. The primary objective is to determine whether continuous COC use leads to higher 12-month continuation rates than use of the standard 28-day COC regimen. Secondary objectives are to 1) compare pregnancy probabilities through 6 and 12 months between the continuous use group and the 28-day group 2) compare COC continuation rates through 6 months between the continuous use group and the 28-day group 3) compare acceptability of the two COC regimens 4) to compare bleeding and other side effects between the continuous use group and the 28-day group 5) to compare hemoglobin/hematocrit between the continuous use group and the 28-day group

Conditions

• Pregnancy Prevention

Interventions

Type	Name	Description
DRUG	Oral contraceptives--ethinyl estradiol, levonorgestrel	3 visits - screening/enrollment, 6-months and 12 months

Timeline

• Start date: 2007-08-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2007-12-11
• Last updated: 2011-10-31

Locations

2 sites across 2 countries: Dominican Republic, Nicaragua