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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Turok, University of Utah
ClinicalTrials.gov Identifier:
NCT00669396
First received: April 25, 2008
Last updated: July 17, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Pregnancy
Drug: Copper T380 IUD
Drug: levonorgestrel

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Pilot Study of Copper T380A IUDs Versus Oral Levonorgestrel for Emergency Contraception

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Pregnancy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    positive urine pregnancy test at anytime within 6 months of presenting for emergency contraception.

  • Infection [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    diagnosis and treatment for pelvic inflammatory disease

  • IUD Expulsion, Removal, or Perforation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    patient reports IUD expulsion, removal, or perforation OR one of these events was documented at the clinic where patient received care.


Enrollment: 57
Study Start Date: April 2008
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
IUD
Drug: Copper T380 IUD
Copper T380 IUD
Other Name: Paragard IUD
Active Comparator: 2
Oral levonorgestrel
Drug: levonorgestrel
1.5 mg
Other Name: Plan B

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669396

Locations
United States, Utah
Planned Parenthood Association of Utah, West Valley City Clinic
West Valley City, Utah, United States, 84119
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: David Turok, MD/MPH University of Utah
  More Information

No publications provided

Responsible Party: David Turok, PI, University of Utah
ClinicalTrials.gov Identifier: NCT00669396     History of Changes
Other Study ID Numbers: 23111, IUDvsPlanBforEC
Study First Received: April 25, 2008
Results First Received: June 18, 2009
Last Updated: July 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Utah:
contraception
emergency contraception
pregnancy prevention after unprotected intercourse

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Copper
Levonorgestrel
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on August 28, 2014