Continuous Use of COCs

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Continuous Versus Cyclic Use of Combined Oral Contraceptive Pills

Conditions
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Pregnancy Prevention

Intervention / Treatment
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* Drug: Oral contraceptives--ethinyl estradiol, levonorgestrel


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Oral contraceptives--ethinyl estradiol, levonorgestrel<br>* 3 visits - screening/enrollment, 6-months and 12 months<br>|
| Active Comparator: B<br> | Drug: Oral contraceptives--ethinyl estradiol, levonorgestrel<br>* 3 visits - screening/enrollment, 6-months and 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12 month cumulative COC discontinuation probabilities |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rates through 6 and 12 months; 6 month cumulative discontinuation probabilities; acceptability; bleeding and other side effects; hemoglobin/hematocrit |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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