Pregnancy Prevention Clinical Trial
Official title:
Continuous Versus Cyclic Use of Combined Oral Contraceptive Pills
Verified date | October 2011 |
Source | FHI 360 |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 362 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 30 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Dominican Republic | PROFAMILIA - Santo Domingo, Dominican Republic | Ens. Luperon | Santo Domingo |
Nicaragua | PROFAMILIA - Managua, Nicaragua | Managua |
Lead Sponsor | Collaborator |
---|---|
FHI 360 | La Asociación Pro Bienestar de la Familia de Guatemala (APROFAM) |
Dominican Republic, Nicaragua,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 12 month cumulative COC discontinuation probabilities | 12 months | No | |
Secondary | Pregnancy rates through 6 and 12 months; 6 month cumulative discontinuation probabilities; acceptability; bleeding and other side effects; hemoglobin/hematocrit | 12 months | No |
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