Copper T380 IUD and Oral Levonorgestrel for Emergency Contraception vs. Plan B for Emergency Contraception - Full Text View

Sponsors and Collaborators:	University of Utah An anonymous Foundation.
Information provided by:	University of Utah
ClinicalTrials.gov Identifier:	NCT00669396

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:	Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Pilot Study of Copper T380A IUDs and Oral Levonorgestrel for Emergency Contraception

Resource links provided by NLM:

MedlinePlus related topics: Birth Control

Drug Information available for: Levonorgestrel

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:

Use of an effective method of contraception at 6 months after requesting emergency contraception [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

pregnancy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
infection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Bleeding patterns [ Time Frame: 6 months ] [ Designated as safety issue: No ]
IUD expulsion, removal, or perforation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	268
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental IUD	Drug: Copper T380 IUD Copper T380 IUD
2: Active Comparator Oral levonorgestrel	Drug: levonorgestrel 1.5 mg

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669396

Locations

United States, Utah
Planned Parenthood Association of Utah, West Valley City Clinic
West Valley City, Utah, United States, 84119

Sponsors and Collaborators

University of Utah

An anonymous Foundation.

Investigators

Principal Investigator:

David Turok, MD/MPH

University of Utah

More Information

No publications provided

Responsible Party:	Department of Obstetrics and Gynecology, University of Utah ( David Turok, MD/MPH )
Study ID Numbers:	IUDvsPlanBforEC
Study First Received:	April 25, 2008
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00669396 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Utah:

contraception
emergency contraception
pregnancy prevention after unprotected intercourse

Study placed in the following topic categories:

Contraceptive Agents
Levonorgestrel
Contraceptives, Oral
Contraceptive Agents, Female

Emergencies
Trace Elements
Micronutrients
Copper

Additional relevant MeSH terms:

Disease Attributes
Contraceptive Agents
Growth Substances
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female
Trace Elements
Copper

Reproductive Control Agents
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Levonorgestrel
Contraceptives, Oral, Synthetic
Emergencies
Micronutrients

ClinicalTrials.gov processed this record on July 02, 2009