Continuous Use of COCs

Pregnancy Prevention Clinical Trial

Official title:

Continuous Versus Cyclic Use of Combined Oral Contraceptive Pills

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00570440
• Other study ID #: 9964
• Status: Completed
• Phase: Phase 4
• First received: December 10, 2007
• Last updated: October 28, 2011
• Start date: August 2007
• Est. completion date: October 2010

Study information

• Verified date: October 2011
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 362
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Pregnancy Prevention

Intervention

Drug:
• Oral contraceptives--ethinyl estradiol, levonorgestrel
3 visits - screening/enrollment, 6-months and 12 months

Locations

Country	Name	City	State
Dominican Republic	PROFAMILIA - Santo Domingo, Dominican Republic	Ens. Luperon	Santo Domingo
Nicaragua	PROFAMILIA - Managua, Nicaragua	Managua

Sponsors (2)

Lead Sponsor	Collaborator
FHI 360	La Asociación Pro Bienestar de la Familia de Guatemala (APROFAM)

Countries where clinical trial is conducted

Dominican Republic,  Nicaragua, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12 month cumulative COC discontinuation probabilities		12 months	No
Secondary	Pregnancy rates through 6 and 12 months; 6 month cumulative discontinuation probabilities; acceptability; bleeding and other side effects; hemoglobin/hematocrit		12 months	No