Oral contraceptives--ethinyl estradiol, levonorgestrel
Drug3 visits - screening/enrollment, 6-months and 12 months
NCT Number: NCT00570440
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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Notify Me18 year–30 year
Female
Interventional
Phase 4
PROFAMILIA - Santo Domingo, Dominican Republic, Ens. Luperon, Santo Domingo Province, Dominican Republic
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
3 visits - screening/enrollment, 6-months and 12 months
Time frame: 12 months
Time frame: 12 months
FHI 360
Other
Continuous Versus Cyclic Use of Combined Oral Contraceptive Pills
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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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