N/A
N=57
Copper T380 IUD Versus Oral Levonorgestrel for Emergency Contraception vs. Plan B for Emergency Contraception
Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT00669396 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Aug 2009
Primary outcome: Primary: Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception — 9; 13 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Copper T380 IUD (Drug); levonorgestrel (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Utah
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception |
9; 13 | — |
| SECONDARY Pregnancy |
0; 2 | — |
| SECONDARY Infection |
0; 0 | — |
| SECONDARY IUD Expulsion, Removal, or Perforation |
5; 0 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00669396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.