Copper T380 IUD Versus Oral Levonorgestrel for Emergency Contraception vs. Plan B for Emergency Contraception
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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 |
- 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.
- 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 |
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| United States, Utah | |
| Planned Parenthood Association of Utah, West Valley City Clinic | |
| West Valley City, Utah, United States, 84119 | |
| Principal Investigator: | David Turok, MD/MPH | University of Utah |
More Information
No publications provided
| Responsible Party: | David Turok, MD/MPH, Department of Obstetrics and Gynecology, 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: | February 18, 2011 |
| 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 June 18, 2013