Back to resultsCopper T380 IUD Versus Oral Levonorgestrel for Emergency Contraception vs. Plan B for Emergency Contraception
Primary Purpose
Pregnancy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Copper T380 IUD
levonorgestrel
Sponsored by
About this trial
This is an interventional prevention trial for Pregnancy focused on measuring contraception, emergency contraception, pregnancy prevention after unprotected intercourse
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
Sites / Locations
- Planned Parenthood Association of Utah, West Valley City Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
IUD
Oral levonorgestrel
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pregnancy
positive urine pregnancy test at anytime within 6 months of presenting for emergency contraception.
Infection
diagnosis and treatment for pelvic inflammatory disease
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00669396
Brief Title
Copper T380 IUD Versus Oral Levonorgestrel for Emergency Contraception vs. Plan B for Emergency Contraception
Official Title
A Pilot Study of Copper T380A IUDs Versus Oral Levonorgestrel for Emergency Contraception
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy
Keywords
contraception, emergency contraception, pregnancy prevention after unprotected intercourse
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
IUD
Arm Title
2
Arm Type
Active Comparator
Arm Description
Oral levonorgestrel
Intervention Type
Drug
Intervention Name(s)
Copper T380 IUD
Other Intervention Name(s)
Paragard IUD
Intervention Description
Copper T380 IUD
Intervention Type
Drug
Intervention Name(s)
levonorgestrel
Other Intervention Name(s)
Plan B
Intervention Description
1.5 mg
Primary Outcome Measure Information:
Title
Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pregnancy
Description
positive urine pregnancy test at anytime within 6 months of presenting for emergency contraception.
Time Frame
6 months
Title
Infection
Description
diagnosis and treatment for pelvic inflammatory disease
Time Frame
6 months
Title
IUD Expulsion, Removal, or Perforation
Description
patient reports IUD expulsion, removal, or perforation OR one of these events was documented at the clinic where patient received care.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Turok, MD/MPH
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Planned Parenthood Association of Utah, West Valley City Clinic
City
West Valley City
State/Province
Utah
ZIP/Postal Code
84119
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Copper T380 IUD Versus Oral Levonorgestrel for Emergency Contraception vs. Plan B for Emergency Contraception
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