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

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
|
- 12 month cumulative COC discontinuation probabilities [ Time Frame: 12 months ]
- 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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Ages Eligible for Study: | 18 Years to 30 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

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
Dominican Republic | |
PROFAMILIA - Santo Domingo, Dominican Republic | |
Ens. Luperon, Santo Domingo, Dominican Republic | |
Nicaragua | |
PROFAMILIA - Managua, Nicaragua | |
Managua, Nicaragua |
Principal Investigator: | Kavita Nanda, MD, MHS | FHI 360 |
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 |