Continuous Use of COCs

Pregnancy Prevention Clinical Trial

Official title: Continuous Versus Cyclic Use of Combined Oral Contraceptive Pills

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pregnancy Prevention

• NCT number: NCT00570440
• Study type: Interventional
• Source: FHI 360
• Status: Completed
• Phase: Phase 4
• Start date: August 2007
• Completion date: October 2010