Continuous Use of COCs

This study has been completed.
Sponsor:
Collaborator:
La Asociación Pro Bienestar de la Familia de Guatemala (APROFAM)
Information provided by (Responsible Party):
FHI 360
ClinicalTrials.gov Identifier:
NCT00570440
First received: December 10, 2007
Last updated: October 28, 2011
Last verified: October 2011

December 10, 2007
October 28, 2011
August 2007
October 2010   (final data collection date for primary outcome measure)
12 month cumulative COC discontinuation probabilities [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00570440 on ClinicalTrials.gov Archive Site
Pregnancy rates through 6 and 12 months; 6 month cumulative discontinuation probabilities; acceptability; bleeding and other side effects; hemoglobin/hematocrit [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Pregnancy Prevention
Drug: Oral contraceptives--ethinyl estradiol, levonorgestrel
3 visits - screening/enrollment, 6-months and 12 months
  • Experimental: A
    Intervention: Drug: Oral contraceptives--ethinyl estradiol, levonorgestrel
  • Active Comparator: B
    Intervention: Drug: Oral contraceptives--ethinyl estradiol, levonorgestrel
Nanda K, Lendvay A, Kwok C, Tolley E, Dubé 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):1012-22. doi: 10.1097/AOG.0000000000000235.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
362
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Female
18 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Nicaragua,   Dominican Republic
 
NCT00570440
9964
Not Provided
FHI 360
FHI 360
La Asociación Pro Bienestar de la Familia de Guatemala (APROFAM)
Principal Investigator: Kavita Nanda, MD, MHS FHI 360
FHI 360
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP