Continuous Use of COCs

Phase 4

Completed

• Conditions: Pregnancy Prevention
• Interventions: Drug: Oral contraceptives--ethinyl estradiol, levonorgestrel

• Registration Number: NCT00570440
• Lead Sponsor: FHI 360

Brief 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

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-12-10
• Study First Submitted QC: 2007-12-10
• Study First Posted: 2007-12-11
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-28
• Last Update Posted: 2011-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 362

Inclusion Criteria

• Age 18-30
• Currently has menstrual periods every 21-35 days
• Willing and able to be randomly assigned to one of the two study groups and to comply with all study requirements
• Has signed the informed consent form
• Has a negative urine pregnancy test at enrollment

Exclusion Criteria

• Has contraindications to COC use (see WHO MEC-3rd edition)

• Is in any other research study

• Has been pregnant in the past 3 months

• Is breastfeeding or has breastfed in the past 3 months

• Is currently using an IUD (women who agree to IUD removal are eligible once the IUD is removed)

• Has had an injection of DMPA in the past 6 months

• Has had an injection of NET-EN in the past 3 months

• Has used combined injectables, oral contraceptive pills, implants, or a hormonal IUD in the past 2 months

• Has had any of the following conditions since her last pregnancy, or since menarche if never pregnant:

  • Pelvic infection treated with antibiotics
  • Diagnosis of infertility
  • Endometriosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Oral contraceptives--ethinyl estradiol, levonorgestrel	-
B	Oral contraceptives--ethinyl estradiol, levonorgestrel	-

Primary Outcome Measures

Name	Time	Method
12 month cumulative COC discontinuation probabilities	12 months

Secondary Outcome Measures

Name	Time	Method
Pregnancy rates through 6 and 12 months; 6 month cumulative discontinuation probabilities; acceptability; bleeding and other side effects; hemoglobin/hematocrit	12 months

Trial Locations

Locations (2)

PROFAMILIA - Santo Domingo, Dominican Republic; 🇩🇴 Ens. Luperon, Santo Domingo, Dominican Republic

PROFAMILIA - Managua, Nicaragua; 🇳🇮 Managua, Nicaragua