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

NCT ID: NCT00669396

Last Updated: 2014-12-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-05-31

Brief Summary

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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

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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.

Conditions

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Pregnancy

Keywords

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contraception emergency contraception pregnancy prevention after unprotected intercourse

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

IUD

Group Type EXPERIMENTAL

Copper T380 IUD

Intervention Type DRUG

Copper T380 IUD

2

Oral levonorgestrel

Group Type ACTIVE_COMPARATOR

levonorgestrel

Intervention Type DRUG

1.5 mg

Interventions

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Copper T380 IUD

Copper T380 IUD

Intervention Type DRUG

levonorgestrel

1.5 mg

Intervention Type DRUG

Other Intervention Names

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Paragard IUD Plan B

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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David Turok

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Turok, MD/MPH

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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Planned Parenthood Association of Utah, West Valley City Clinic

West Valley City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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IUDvsPlanBforEC

Identifier Type: -

Identifier Source: secondary_id

23111

Identifier Type: -

Identifier Source: org_study_id