Copper T380 IUD Versus Oral Levonorgestrel for Emergency Contraception vs. Plan B for Emergency Contraception - Tabular View

Tracking Information

First Received Date ^ICMJE

April 25, 2008

Last Updated Date

August 11, 2009

Start Date ^ICMJE

April 2008

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00669396 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pregnancy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Infection [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
IUD Expulsion, Removal, or Perforation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

pregnancy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
infection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Bleeding patterns [ Time Frame: 6 months ] [ Designated as safety issue: No ]
IUD expulsion, removal, or perforation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title ^ICMJE

Copper T380 IUD Versus Oral Levonorgestrel for Emergency Contraception vs. Plan B for Emergency Contraception

Official Title ^ICMJE

A Pilot Study of Copper T380A IUDs Versus Oral Levonorgestrel for Emergency Contraception

Brief Summary

The purpose of this study is to see if women presenting for emergency contraception (EC) are willing to accept the copper intrauterine device (IUD). This study will also compare the use of effective methods of contraception between women who selected the copper IUD or Plan B 6 months after they received EC.

Detailed Description

This study seeks to estimate the acceptance of Copper IUD use amongst people presenting for EC. This will be accomplished by offering all women who present for EC at participating Planned Parenthood Association of Utah (PPAU) clinics during the study period the option of having the copper IUD or Plan B. Women who agree to study participation will be followed for 6 months. The primary outcome for the study is the use of a reliable method of contraception 6 months after presenting for EC.

Secondary outcomes measured will be pregnancies, abortions, repeat Plan B use, presence of gonorrhea or Chlamydia infection at the time of presentation for EC, number of days to first bleeding episode and duration of that bleeding episode, further bleeding patterns, frequency of unprotected intercourse, use of a barrier method for prevention of sexually transmitted infections, patient satisfaction with the chosen method and symptoms possibly related to contraception use. Patients selecting the IUD will be assessed for IUD expulsion, perforation, and removal.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Pregnancy

Intervention ^ICMJE

Drug: Copper T380 IUD
Drug: levonorgestrel

Study Arms / Comparison Groups

Experimental: IUD
Active Comparator: Oral levonorgestrel

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2009

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Women 18-45 years old, in need of EC (had unprotected intercourse within 120 hours), willing to give consent for participation in research, willing to comply with the study requirements, and accessible by telephone.
Patients selecting the IUD need to identify themselves as desiring long-term contraception.

Exclusion Criteria:

Current pregnancy,
Had pelvic inflammatory disease or a septic abortion within the past 3 months or gonorrheal or chlamydial infection in the last 60 days,
Current behavior suggesting a high risk for pelvic inflammatory disease
Allergy to copper, or Wilson's disease (for patients selecting Paragard) or allergy to levonorgestrel (for patients selecting Plan B)
Intracavitary of symptomatic uterine fibroids, and abnormalities of the uterus that distort the uterine cavity,
Mucopurulent cervicitis,
A previously placed IUD that has not been removed
Genital bleeding of unknown etiology
Ovarian, cervical or endometrial cancer,
Small uterine cavity

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00669396

Responsible Party

David Turok, MD/MPH, Department of Obstetrics and Gynecology, University of Utah

Study ID Numbers ^ICMJE

23111, IUDvsPlanBforEC

Study Sponsor ^ICMJE

University of Utah

Collaborators ^ICMJE

An anonymous Foundation.

Investigators ^ICMJE

Principal Investigator:

David Turok, MD/MPH

University of Utah

Information Provided By

University of Utah

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP