NCT01963962

Brief Summary

The purpose of this study is to see how often women who come to a family planning clinic for emergency contraception, the morning after pill, are willing to use either the copper IUD or the levonorgestrel IUD. The investigators will also see if pregnancies occur in those choosing the levonorgestrel IUD and if people continue to use the IUD for 1 year.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
188

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

July 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

August 8, 2016

Status Verified

August 1, 2016

Enrollment Period

2.6 years

First QC Date

October 11, 2013

Last Update Submit

August 4, 2016

Conditions

Emergency Contraception

Keywords

Emergency contraceptionLevonorgestrel IUDCopper IUDOral Levonorgestrel

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rates in first month after IUD insertion

    Participants will have a urine pregnancy test at the clinic. They will also be given a home urine pregnancy test to check if they are not able to return to clinic and will give results by phone or electronic communication.

    4 weeks

Secondary Outcomes (1)

  • 1 Year IUD continuation rates

    1 year

Other Outcomes (1)

  • Willingness to be randomized to either the copper or levonorgestrel IUD for emergency contraception.

    At enrollment

Study Arms (2)

Copper IUD

Women selecting the copper IUD for emergency contraception and to use for contraception after

Drug: Copper IUD

Levonorgestrel IUD

Women who select oral levonorgestrel for emergency contraception and begin the levonorgestrel IUD for ongoing contraception at the same time.

Drug: Levonorgestrel IUD

Interventions

Copper IUDDRUG
Also known as: Paragard IUD
Copper IUD
Levonorgestrel IUDDRUG
Also known as: Mirena IUD
Levonorgestrel IUD

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women presenting for emergency contraception to family planning clinics in Salt Lake City, UT

You may qualify if:

  • \. In need of EC (had unprotected intercourse within 120 hours - 5 days)
  • \. Desire to prevent pregnancy for 1 year
  • \. Fluent in English and/or Spanish
  • \. Have a regular menstrual cycle (24-35 days)
  • \. Know their last menstrual period (+/-3 days)
  • \. Be willing to comply with the study requirements
  • \. Participants current preferred phone number must be functioning at the time of study entry and will be tested prior to enrollment

You may not qualify if:

  • \. Current pregnancy
  • \. Breastfeeding
  • \. Intrauterine infection within the past 3 months
  • \. Sterilization
  • \. Already have an IUD or contraceptive implant (Implanon) in place
  • \. Vaginal bleeding of unknown etiology
  • \. Known Gonorrhea or Chlamydia infection in the last 30 days (unless successfully treated at least 7 days prior to study entry)
  • \. Allergy to LNG (for LNG IUD patients)
  • \. Allergy to copper or Wilson's disease (for Copper IUD patients)
  • \. Known abnormalities of the uterus that distort the uterine cavity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Planned Parenthood Association of Utah

Salt Lake City, Utah, 84102, United States

Location

Related Publications (2)

  • Boraas CM, Sanders JN, Schwarz EB, Thompson I, Turok DK. Risk of Pregnancy With Levonorgestrel-Releasing Intrauterine System Placement 6-14 Days After Unprotected Sexual Intercourse. Obstet Gynecol. 2021 Apr 1;137(4):623-625. doi: 10.1097/AOG.0000000000004118.

    PMID: 33706343DERIVED

  • Turok DK, Sanders JN, Thompson IS, Royer PA, Eggebroten J, Gawron LM. Preference for and efficacy of oral levonorgestrel for emergency contraception with concomitant placement of a levonorgestrel IUD: a prospective cohort study. Contraception. 2016 Jun;93(6):526-32. doi: 10.1016/j.contraception.2016.01.009. Epub 2016 Mar 2.

    PMID: 26944863DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine to test for progesterone and/or pregnandiol

MeSH Terms

Interventions

Intrauterine Devices, Copper

Intervention Hierarchy (Ancestors)

Intrauterine Devices, MedicatedIntrauterine DevicesContraceptive Devices, FemaleContraceptive DevicesEquipment and Supplies

Study Officials

  • David Turok, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

October 11, 2013

First Posted

October 17, 2013

Study Start

July 1, 2013

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

August 8, 2016

Record last verified: 2016-08

Locations

US(1)