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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00570440 |
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Date of registration:
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10/12/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Continuous Use of COCs
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Scientific title:
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Continuous Versus Cyclic Use of Combined Oral Contraceptive Pills |
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Date of first enrolment:
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August 2007 |
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Target sample size:
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362 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00570440 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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Dominican Republic
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Guatemala
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Nicaragua
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Contacts
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Name:
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Kavita Nanda, MD, MHS |
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Address:
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Telephone:
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Email:
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Affiliation:
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FHI 360 |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
30 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pregnancy Prevention
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Intervention(s)
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Drug: Oral contraceptives--ethinyl estradiol, levonorgestrel
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Primary Outcome(s)
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12 month cumulative COC discontinuation probabilities
[Time Frame: 12 months]
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Secondary Outcome(s)
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Pregnancy rates through 6 and 12 months; 6 month cumulative discontinuation probabilities; acceptability; bleeding and other side effects; hemoglobin/hematocrit
[Time Frame: 12 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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