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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00669396
• Other study ID #: 23111
• Secondary ID: IUDvsPlanBforEC
• Status: Completed
• Phase: N/A
• First received: April 25, 2008
• Last updated: December 4, 2014
• Start date: April 2008
• Est. completion date: May 2009

Study information

• Verified date: December 2014
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Emergencies
• Pregnancy

Intervention

Drug:
• Copper T380 IUD
Copper T380 IUD
• levonorgestrel
1.5 mg

Locations

Country	Name	City	State
United States	Planned Parenthood Association of Utah, West Valley City Clinic	West Valley City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months	No
Secondary	Pregnancy	positive urine pregnancy test at anytime within 6 months of presenting for emergency contraception.	6 months	No
Secondary	Infection	diagnosis and treatment for pelvic inflammatory disease	6 months	Yes
Secondary	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.	6 months	No