Continuous Use of COCs

NCT ID: NCT00570440

Last Updated: 2011-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 362 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2010-10-31

Brief Summary

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

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

Conditions

Pregnancy Prevention

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

A

Group Type: EXPERIMENTAL

Oral contraceptives--ethinyl estradiol, levonorgestrel

Intervention Type: DRUG

3 visits - screening/enrollment, 6-months and 12 months

B

Group Type: ACTIVE_COMPARATOR

Oral contraceptives--ethinyl estradiol, levonorgestrel

Intervention Type: DRUG

3 visits - screening/enrollment, 6-months and 12 months

Interventions

Oral contraceptives--ethinyl estradiol, levonorgestrel

3 visits - screening/enrollment, 6-months and 12 months

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: collaborator

FHI 360

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kavita Nanda, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

FHI 360

Locations

PROFAMILIA - Santo Domingo, Dominican Republic

Ens. Luperon, Santo Domingo Province, Dominican Republic

PROFAMILIA - Managua, Nicaragua

Managua, Managua Department, Nicaragua

Countries

Guatemala; Dominican Republic; Nicaragua

References

Nanda K, Lendvay A, Kwok C, Tolley E, Dube 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):1012-1022. doi: 10.1097/AOG.0000000000000235.

Reference Type: DERIVED

PMID: 24785854 (View on PubMed)

Other Identifiers

9964

Identifier Type: -

Identifier Source: org_study_id