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

Study Identifier:
23111
CT.gov Identifier:
NCT00669396
EudraCT Identifier:
202552364811
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Study Complete

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Study Summary

To compare the use of effective methods of contraception between women who selected the copper IUD or Plan B 6 months after they received EC.

To see if women presenting for emergency contraception (EC) are willing to accept the copper intrauterine device (IUD).

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Unmapped
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
II
Sex
Female
Age
18 - 45 Years
Study Drug
Drug: Subjects who present for emergency contraception will receive Copper T380 IUD (n = 23) or 1.5 mg of levonorgestrel (n = 34).
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Drug: Subjects will be followed for 6 months.
Study Status
Indicates the current recruitment status or the expanded access status
Study Complete

Requirements information
Inclusion criteria
  • Ages Eligible for Study
  • 18 Years to 45 Years,
  • 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
  • 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.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Kyriakos Papadopoulos
Status
Recruiting
Condition(s) Treated at Site
Unmapped