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

NCT00669396 | Completed Results DMC

• 2 other identifiers: 23111IUDvsPlanBforEC
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

contraception; emergency contraception; pregnancy prevention after unprotected intercourse

Outcome Measures

Primary Outcomes (1)

• Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception

  Use of a method of contraception with a typical efficacy rate \>= to 92%. This includes combined hormonal contraception (combined oral contraceptive pills, the contraceptive patch and ring), sterilization, IUDs, Depo-provera, and contraceptive implants.

  6 months

Secondary Outcomes (3)

• Pregnancy

  6 months

• Infection

  6 months

• IUD Expulsion, Removal, or Perforation

  6 months

Study Arms (2)

1

EXPERIMENTAL

IUD

Drug: Copper T380 IUD

2

ACTIVE COMPARATOR

Oral levonorgestrel

Drug: levonorgestrel

Interventions

Copper T380 IUD DRUG

Copper T380 IUD

Also known as: Paragard IUD

1

levonorgestrel DRUG

1.5 mg

Also known as: Plan B

2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Planned Parenthood Association of Utah, West Valley City Clinic

West Valley City, Utah, 84119, United States

Location

MeSH Terms

Interventions

Levonorgestrel

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: David Turok, MD
• Organization: University of Utah

david.turok@hsc.utah.edu

801-581-7647

Study Officials

• David Turok, MD/MPH

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: April 25, 2008
• First Posted: April 30, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: December 22, 2014
• Results First Posted: August 6, 2009

Record last verified: 2014-12

Locations

US (1)