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Continuous Use of COCs

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ClinicalTrials.gov Identifier: NCT00570440
Recruitment Status : Completed
First Posted : December 11, 2007
Last Update Posted : October 31, 2011
Sponsor:
Collaborator:
La Asociación Pro Bienestar de la Familia de Guatemala (APROFAM)
Information provided by (Responsible Party):
FHI 360

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pregnancy Prevention Drug: Oral contraceptives--ethinyl estradiol, levonorgestrel Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 362 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Continuous Versus Cyclic Use of Combined Oral Contraceptive Pills
Study Start Date : August 2007
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: A Drug: Oral contraceptives--ethinyl estradiol, levonorgestrel
3 visits - screening/enrollment, 6-months and 12 months
Active Comparator: B Drug: Oral contraceptives--ethinyl estradiol, levonorgestrel
3 visits - screening/enrollment, 6-months and 12 months


Outcome Measures
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Primary Outcome Measures :
  1. 12 month cumulative COC discontinuation probabilities [ Time Frame: 12 months ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00570440


Locations
Dominican Republic
PROFAMILIA - Santo Domingo, Dominican Republic
Ens. Luperon, Santo Domingo, Dominican Republic
Nicaragua
PROFAMILIA - Managua, Nicaragua
Managua, Nicaragua
Sponsors and Collaborators
FHI 360
La Asociación Pro Bienestar de la Familia de Guatemala (APROFAM)
Investigators
Principal Investigator: Kavita Nanda, MD, MHS FHI 360
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT00570440     History of Changes
Other Study ID Numbers: 9964
First Posted: December 11, 2007    Key Record Dates
Last Update Posted: October 31, 2011
Last Verified: October 2011

Keywords provided by FHI 360:
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
IU international units
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

Additional relevant MeSH terms:
Estradiol
Ethinyl Estradiol
Contraceptive Agents
Levonorgestrel
Contraceptives, Oral
Estrogens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic