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

A Pilot Study of Copper T380A IUDs Versus Oral Levonorgestrel 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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Drug: Copper T380 IUD; Drug: levonorgestrel

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 Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • West Valley City, Utah, United States, 84119
      • Planned Parenthood Association of Utah, West Valley City Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; IUD	Drug: Copper T380 IUD; Copper T380 IUD; Other Names: Paragard IUD
Active Comparator: 2; Oral levonorgestrel	Drug: levonorgestrel; 1.5 mg; Other Names: Plan B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy	positive urine pregnancy test at anytime within 6 months of presenting for emergency contraception.	6 months
Infection	diagnosis and treatment for pelvic inflammatory disease	6 months
IUD Expulsion, Removal, or Perforation	patient reports IUD expulsion, removal, or perforation OR one of these events was documented at the clinic where patient received care.	6 months

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: David Turok, MD/MPH, University of Utah

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: April 25, 2008
• First Submitted That Met QC Criteria: April 28, 2008
• First Posted (Estimate): April 30, 2008

Study Record Updates

• Last Update Posted (Estimate): December 22, 2014
• Last Update Submitted That Met QC Criteria: December 4, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: contraception; emergency contraception; pregnancy prevention after unprotected intercourse
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Physiological Effects of Drugs; Trace Elements; Micronutrients; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Copper; Levonorgestrel
• Other Study ID Numbers: 23111; IUDvsPlanBforEC