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Completed

NCT Number: NCT00570440

Continuous Use of COCs

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.

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Key information

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

PROFAMILIA - Santo Domingo, Dominican Republic, Ens. Luperon, Santo Domingo Province, Dominican Republic

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral contraceptives--ethinyl estradiol, levonorgestrel

Drug

3 visits - screening/enrollment, 6-months and 12 months

Primary outcomes

  1. 12 month cumulative COC discontinuation probabilities

    Time frame: 12 months

Secondary outcomes

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

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

FHI 360

Other

Collaborators

  • La Asociación Pro Bienestar de la Familia de Guatemala (APROFAM)

Registry information

Official study title

Continuous Versus Cyclic Use of Combined Oral Contraceptive Pills

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Dec 11, 2007
Registry last updated
Oct 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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