NCT00966771

Brief Summary

The purpose of this study is to see if women presenting for emergency contraception (EC) and choose the copper intrauterine device (IUD) will have fewer unplanned pregnancies in the next year compared to women who choose oral levonorgestrel for EC. The study will also compare use of an effective method of contraception in the year after they received EC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
548

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

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

First Submitted

Initial submission to the registry

August 25, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

February 6, 2017

Status Verified

October 1, 2016

Enrollment Period

1.8 years

First QC Date

August 25, 2009

Last Update Submit

February 2, 2017

Conditions

Pregnancy

Keywords

contraceptionemergency contraceptionpregnancy prevention after unprotected intercourse

Outcome Measures

Primary Outcomes (1)

  • Unplanned pregnancy

    within 12 months of presenting for EC

Secondary Outcomes (2)

  • Use of an effective method of contraception in the year following use of emergency contraception.

    12 months

  • IUD expulsion, removal or perforation

    12 months

Study Arms (2)

IUD

Women presenting for emergency contraception who select the copper IUD

Drug: Copper T380 IUD

Oral levonorgestrel

Women presenting for emergency contraception who select oral levonorgestrel

Drug: Oral levonorgestrel

Interventions

Copper T380 IUDDRUG

copper T 380 IUD

Also known as: Paragard IUD
IUD
Oral levonorgestrelDRUG

1.5 mg

Also known as: Plan B
Oral levonorgestrel

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women presenting to family planning clinics for emergency contraception

You may qualify if:

  • Women 18-30 years old,
  • in need of emergency contraception (had unprotected intercourse within 120 hours),
  • willing to give consent for participation in research,
  • willing to comply with study requirements, and
  • accessible by telephone.
  • Participants selecting the IUD need to identify themselves as desiring long-term contraception.

You may not qualify if:

  • Current pregnancy
  • Had pelvic inflammatory disease or septic abortion within the past 3 months or had gonorrhea or chlamydia infection in the last 60 days
  • Current behavior suggesting a high risk for pelvic inflammatory disease
  • Allergy to copper or Wilson's disease (for participants selecting the copper IUD) or allergy to levonorgestrel (for participants selecting oral levonorgestrel)
  • Abnormalities of the uterus that distort the uterine cavity
  • Mucopurulent cervicitis
  • A previously placed IUD that has not been removed
  • Genital bleeding of an unknown etiology
  • Ovarian, cervical, or endometrial cancer
  • Small uterine cavity (\< 6cm)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Planned Parenthood Association of Utah Salt Lake City Clinic

Salt Lake City, Utah, 84102-3430, United States

Location

Planned Parenthood Association of Utah, West Valley City Clinic

West Valley City, Utah, 84119-4715, United States

Location

Related Publications (2)

  • Royer PA, Turok DK, Sanders JN, Saltzman HM. Choice of Emergency Contraceptive and Decision Making Regarding Subsequent Unintended Pregnancy. J Womens Health (Larchmt). 2016 Oct;25(10):1038-1043. doi: 10.1089/jwh.2015.5625. Epub 2016 Mar 31.

    PMID: 27032057DERIVED

  • Torres LN, Turok DK, Sanders JN, Jacobson JC, Dermish AI, Ward K. We should really keep in touch: predictors of the ability to maintain contact with contraception clinical trial participants over 12 months. Contraception. 2014 Dec;90(6):575-80. doi: 10.1016/j.contraception.2014.07.013. Epub 2014 Aug 1.

    PMID: 25242443DERIVED

MeSH Terms

Interventions

Levonorgestrel

Intervention Hierarchy (Ancestors)

NorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • David Turok, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

August 25, 2009

First Posted

August 27, 2009

Study Start

October 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

February 6, 2017

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)