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Completed

NCT Number: NCT00669396

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

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.

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Key information

Conditions

Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Planned Parenthood Association of Utah, West Valley City Clinic

West Valley City, Utah, 84119, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Copper T380 IUD

Drug

Copper T380 IUD

Other names: Paragard IUD

Levonorgestrel

Drug

1.5 mg

Other names: Plan B

Primary outcomes

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

    Time frame: 6 months

    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.

Secondary outcomes

  1. Pregnancy

    Time frame: 6 months

    positive urine pregnancy test at anytime within 6 months of presenting for emergency contraception.

  2. Infection

    Time frame: 6 months

    diagnosis and treatment for pelvic inflammatory disease

  3. IUD Expulsion, Removal, or Perforation

    Time frame: 6 months

    patient reports IUD expulsion, removal, or perforation OR one of these events was documented at the clinic where patient received care.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 30, 2008
Registry last updated
Dec 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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