NCT00570440

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
362

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2007

Typical duration for phase_4

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

October 31, 2011

Status Verified

October 1, 2011

Enrollment Period

3.2 years

First QC Date

December 10, 2007

Last Update Submit

October 28, 2011

Conditions

Pregnancy Prevention

Keywords

AE adverse eventAIDS acquired immunodeficiency syndromeALT (SGPT) alanine aminotransferaseART antiretroviral therapyAST (SGOT) aspartate aminotransferaseDCF data collection formsDMC Data Monitoring CommitteeFDA (U.S.) Food and Drug AdministrationGCP Good Clinical Practice guidelinesHB sAg Hepatitis B surface antigenICH International Conference of HarmonisationIND Investigational New Drug ApplicationIRB Institutional Review BoardIU international unitsmg milligram(s)mm3 cubic millimeter(s)PCR polymerase chain reactionSAE serious adverse eventµg microgramULN upper limit of the normal rangeWB Western Blot

Outcome Measures

Primary Outcomes (1)

  • 12 month cumulative COC discontinuation probabilities

    12 months

Secondary Outcomes (1)

  • Pregnancy rates through 6 and 12 months; 6 month cumulative discontinuation probabilities; acceptability; bleeding and other side effects; hemoglobin/hematocrit

    12 months

Study Arms (2)

A

EXPERIMENTAL
Drug: Oral contraceptives--ethinyl estradiol, levonorgestrel

B

ACTIVE COMPARATOR
Drug: Oral contraceptives--ethinyl estradiol, levonorgestrel

Interventions

Oral contraceptives--ethinyl estradiol, levonorgestrelDRUG

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

AB

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

PROFAMILIA - Santo Domingo, Dominican Republic

Ens. Luperon, Santo Domingo Province, Dominican Republic

Location

PROFAMILIA - Managua, Nicaragua

Managua, Managua Department, Nicaragua

Location

Related Publications (1)

  • 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.

    PMID: 24785854DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Ethinyl EstradiolLevonorgestrel

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

NorpregnatrienesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNorgestrelNorpregnenes

Study Officials

  • Kavita Nanda, MD, MHS

    FHI 360

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2007

First Posted

December 11, 2007

Study Start

August 1, 2007

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

October 31, 2011

Record last verified: 2011-10

Locations

DO(1)NI(1)