The Copper T380A IUD vs. Oral Levonorgestrel for Emergenc... | NCT00966771

Studies
The Copper T380A IUD vs. Oral Levonorgestrel for Emergency Contraception

NCT00966771

Sponsor

University of Utah

Status

Completed

Last Update Posted

Feb 6, 2017Estimated

Enrollment

548Actual

Phase

Not provided

Conditions

Pregnancy

Interventions

Copper T380 IUD
Oral levonorgestrel

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R21HD063028-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Aug 25, 2009

First Submission Date that Met QC Criteria

Aug 26, 2009

First Posted Date

Aug 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2017

Last Update Posted Date

Feb 6, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

David Turok, Clinical Assistant Professor, University of UtahPrincipal Investigator

Lead Sponsor

University of UtahOTHER

Collaborators

Name	Class
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	NIH
Society of Family Planning	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

All women presenting to 2 Planned Parenthood Association of Utah clinics in Salt Lake City will be offered participation in this study. Women will select either the copper IUD or oral levonorgestrel for EC. The primary outcome is unplanned pregnancy in the year following presentation for EC.

Secondary outcomes include use of an effective method of contraception over the next year, abortions, repeat use of EC, number of days to first bleeding episode and duration of that bleeding episode, use of a barrier method to prevent sexually transmitted infections, patient satisfaction with the chosen method of EC and contraception. Participants selecting the IUD will be assessed for IUD expulsion, perforation, and removal.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

548Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Copper T380 IUD	Drug	copper T 380 IUD	IUD	Paragard IUD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Unplanned pregnancy		within 12 months of presenting for EC

Secondary Outcomes

Measure	Description	Time Frame
Use of an effective method of contraception in the year following use of emergency contraception.		12 months
IUD expulsion, removal or perforation		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Women presenting to family planning clinics for emergency contraception

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Turok, MD	University of Utah	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Planned Parenthood Association of Utah Salt Lake City Clinic		Salt Lake City	Utah	84102-3430	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27032057	Derived	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.
25242443	Derived	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.

ID	Term
D009644	Norgestrel
D009652	Norpregnenes
D009650	Norpregnanes
D009654	Norsteroids
D013256