Continuous Use of COCs

Continuous Versus Cyclic Use of Combined Oral Contraceptive Pills

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Prevention
• Intervention / Treatment: Drug: Oral contraceptives--ethinyl estradiol, levonorgestrel

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 Type: Interventional
• Enrollment (Anticipated): 362
• Phase: Phase 4

Contacts and Locations

Study Locations

• Dominican Republic
  • Santo Domingo
    • Ens. Luperon, Santo Domingo, Dominican Republic
      • PROFAMILIA - Santo Domingo, Dominican Republic
• Nicaragua
  • Managua, Nicaragua
    • PROFAMILIA - Managua, Nicaragua

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: B	Drug: Oral contraceptives--ethinyl estradiol, levonorgestrel; 3 visits - screening/enrollment, 6-months and 12 months
Experimental: A	Drug: Oral contraceptives--ethinyl estradiol, levonorgestrel; 3 visits - screening/enrollment, 6-months and 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
12 month cumulative COC discontinuation probabilities	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: FHI 360
• Collaborators: La Asociación Pro Bienestar de la Familia de Guatemala (APROFAM)
• Investigators: Principal Investigator: Kavita Nanda, MD, MHS, FHI 360

Publications and helpful links

General Publications

• Nanda K, Lendvay A, Kwok C, Tolley E, Dube K, Brache V. Continuous compared with cyclic use of oral contraceptive pills in the Dominican Republic: a randomized controlled trial. Obstet Gynecol. 2014 May;123(5):1012-1022. doi: 10.1097/AOG.0000000000000235.

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: December 10, 2007
• First Submitted That Met QC Criteria: December 10, 2007
• First Posted (Estimate): December 11, 2007

Study Record Updates

• Last Update Posted (Estimate): October 31, 2011
• Last Update Submitted That Met QC Criteria: October 28, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: AE adverse event; AIDS acquired immunodeficiency syndrome; ALT (SGPT) alanine aminotransferase; ART antiretroviral therapy; AST (SGOT) aspartate aminotransferase; DCF data collection forms; DMC Data Monitoring Committee; FDA (U.S.) Food and Drug Administration; GCP Good Clinical Practice guidelines; HB sAg Hepatitis B surface antigen; ICH International Conference of Harmonisation; IND Investigational New Drug Application; IRB Institutional Review Board; mg milligram(s); mm3 cubic millimeter(s); PCR polymerase chain reaction; SAE serious adverse event; µg microgram; ULN upper limit of the normal range; WB Western Blot; IU international units
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Contraceptive Agents, Hormonal; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Levonorgestrel; Estradiol; Contraceptive Agents; Ethinyl Estradiol; Contraceptives, Oral
• Other Study ID Numbers: 9964