NCT00060463

Brief Summary

This study will evaluate the effect of easy access to emergency contraceptive pills (ECPs) on the rates of pregnancy and sexually transmitted infections (STIs).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,490

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Oct 2002

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

2 active sites

Status
unknown

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

October 1, 2002

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2003

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

June 24, 2005

Status Verified

October 1, 2004

First QC Date

May 6, 2003

Last Update Submit

June 23, 2005

Conditions

Keywords

Emergency contraceptive pillsPregnancySexually transmitted infectionChlamydiaGonorrheaTrichomonasContraception

Interventions

Eligibility Criteria

Age14 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Sexual intercourse with a male partner at least twice in the month prior to study entry
  • Does not desire pregnancy within 1 year of study entry
  • weeks since the end of her last pregnancy and has had at least one menstrual period since resolution of her last pregnancy
  • Literate in English or Spanish

You may not qualify if:

  • Surgically sterilized or intends to become sterilized within 1 year of study entry
  • Intrauterine device or a hormonal implant in place or intends to have one inserted within 1 year of study entry
  • Received an injection of a long-term contraceptive hormone (such as depot-medroxyprogesterone acetate) within 6 months of study entry or intends to receive one within 1 year of study entry
  • Intends to use Lunelle, the vaginal contraceptive ring, or the contraceptive patch for contraception within 1 year of study entry
  • Intends to use partners' vasectomy as her method of contraception within 1 year of study entry
  • Pregnant or breastfeeding
  • Known or suspected infertility
  • Previously participated in this study
  • Planning to move out of the study area within 1 year of study entry
  • Currently participating in another research study that would interfere with the conduct of this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Planned Parenthood Mar Monte / University of California at San Francisco

Reno, Nevada, United States

Location

Planned Parenthood of Central North Carolina

Durham, North Carolina, United States

Location

Related Publications (2)

  • Weaver MA, Raymond EG, Baecher L. Attitude and behavior effects in a randomized trial of increased access to emergency contraception. Obstet Gynecol. 2009 Jan;113(1):107-116. doi: 10.1097/AOG.0b013e318190c0fe.

  • Raymond EG, Stewart F, Weaver M, Monteith C, Van Der Pol B. Impact of increased access to emergency contraceptive pills: a randomized controlled trial. Obstet Gynecol. 2006 Nov;108(5):1098-106. doi: 10.1097/01.AOG.0000235708.91572.db.

MeSH Terms

Conditions

Sexually Transmitted DiseasesChlamydia InfectionsGonorrheaTrichomonas Infections

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsChlamydiaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesSexually Transmitted Diseases, BacterialNeisseriaceae InfectionsProtozoan InfectionsParasitic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

May 6, 2003

First Posted

May 7, 2003

Study Start

October 1, 2002

Study Completion

October 1, 2005

Last Updated

June 24, 2005

Record last verified: 2004-10

Locations