Continuous Use of COCs - Full Text View

Purpose

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.

Condition	Intervention	Phase
Pregnancy Prevention	Drug: Oral contraceptives--ethinyl estradiol, levonorgestrel	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Continuous Versus Cyclic Use of Combined Oral Contraceptive Pills

Resource links provided by NLM:

Drug Information available for: Estradiol Ethinylestradiol Levonorgestrel

U.S. FDA Resources

Further study details as provided by FHI 360:

Primary Outcome Measures:

12 month cumulative COC discontinuation probabilities [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pregnancy rates through 6 and 12 months; 6 month cumulative discontinuation probabilities; acceptability; bleeding and other side effects; hemoglobin/hematocrit [ Time Frame: 12 months ] [ Designated as safety issue: No ]


Estimated Enrollment:	362
Study Start Date:	August 2007
Study Completion Date:	October 2010
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Detailed Description:

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

Eligibility


Ages Eligible for Study:	18 Years to 30 Years (Adult)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570440

Locations


Dominican Republic
PROFAMILIA - Santo Domingo, Dominican Republic
Ens. Luperon, Santo Domingo, Dominican Republic
Nicaragua
PROFAMILIA - Managua, Nicaragua
Managua, Nicaragua

Sponsors and Collaborators

FHI 360

La Asociación Pro Bienestar de la Familia de Guatemala (APROFAM)

Investigators


Principal Investigator:	Kavita Nanda, MD, MHS	FHI 360

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nanda K, Lendvay A, Kwok C, Tolley E, Dubé K, Brache V. Continuous compared with cyclic use of oral contraceptive pills in the Dominican Republic: a randomized controlled trial. Obstet Gynecol. 2014 May;123(5):1012-22. doi: 10.1097/AOG.0000000000000235.


Responsible Party:	FHI 360
ClinicalTrials.gov Identifier:	NCT00570440 History of Changes
Other Study ID Numbers:	9964
Study First Received:	December 10, 2007
Last Updated:	October 28, 2011
Health Authority:	United States: Institutional Review Board

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:


Ethinyl Estradiol Estradiol Contraceptive Agents Levonorgestrel Contraceptives, Oral Contraceptives, Oral, Combined Estrogens	Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Reproductive Control Agents Contraceptive Agents, Female Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on September 26, 2016