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

• Sponsor: University of Utah (Other)
• Overall Status: Completed
• CT.gov ID: NCT00669396
• Collaborator: (none)
• Enrollment: 57
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 4.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy	Drug: Copper T380 IUD; Drug: levonorgestrel	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Pilot Study of Copper T380A IUDs Versus Oral Levonorgestrel for Emergency Contraception
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 IUD	Drug: Copper T380 IUD; Copper T380 IUD; Other Names: Paragard IUD
Active Comparator: 2 Oral levonorgestrel	Drug: levonorgestrel; 1.5 mg; Other Names: Plan B

Outcome Measures

Primary Outcome Measures

1. Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception [6 months]

   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

1. Pregnancy [6 months]

   positive urine pregnancy test at anytime within 6 months of presenting for emergency contraception.

2. Infection [6 months]

   diagnosis and treatment for pelvic inflammatory disease

3. IUD Expulsion, Removal, or Perforation [6 months]

   patient reports IUD expulsion, removal, or perforation OR one of these events was documented at the clinic where patient received care.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes 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

Locations

	Site	City	State	Country	Postal Code
1	Planned Parenthood Association of Utah, West Valley City Clinic	West Valley City	Utah	United States	84119

Sponsors and Collaborators

• University of Utah

Investigators

• Principal Investigator: David Turok, MD/MPH, University of Utah

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David Turok, PI, University of Utah
• ClinicalTrials.gov Identifier: NCT00669396
• Other Study ID Numbers: 23111; IUDvsPlanBforEC
• First Posted: Apr 30, 2008
• Last Update Posted: Dec 22, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by David Turok, PI, University of Utah: contraception; emergency contraception; pregnancy prevention after unprotected intercourse
• Additional relevant MeSH terms: Emergencies; Copper; Levonorgestrel

Study Results

Participant Flow

Arm/Group Title	Copper T380 IUD	Levonorgestrel
Arm/Group Description	IUD	Oral levonorgestrel
Period Title: Overall Study
STARTED	23	34
COMPLETED	13	22
NOT COMPLETED	10	12

Baseline Characteristics

Arm/Group Title	Copper T380 IUD	Levonorgestrel	Total
Arm/Group Description	IUD	Oral levonorgestrel	Total of all reporting groups
Overall Participants	23	34	57
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	23 100%	34 100%	57 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	24.7 (6.7)	23.0 (4.7)	23.7 (5.6)
Sex: Female, Male (Count of Participants)
Female	23 100%	34 100%	57 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	23 100%	34 100%	57 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Copper T380 IUD	Levonorgestrel
Arm/Group Description	IUD	Oral levonorgestrel
Measure Participants	13	22
Number [participants]	9 39.1%	13 38.2%

2. Secondary Outcome

Title	Pregnancy
Description	positive urine pregnancy test at anytime within 6 months of presenting for emergency contraception.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Copper T380 IUD	Levonorgestrel
Arm/Group Description	IUD	Oral levonorgestrel
Measure Participants	13	22
Number [participants]	0 0%	2 5.9%

3. Secondary Outcome

Title	Infection
Description	diagnosis and treatment for pelvic inflammatory disease
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Copper T380 IUD	Levonorgestrel
Arm/Group Description	IUD	Oral levonorgestrel
Measure Participants	13	22
Number [participants]	0 0%	0 0%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Copper T380 IUD	Levonorgestrel
Arm/Group Description	IUD	Oral levonorgestrel
Measure Participants	13	22
Number [participants]	5 21.7%	0 0%

Adverse Events

Arm/Group Title	Copper T380 IUD		Levonorgestrel
Arm/Group Description	IUD		Oral levonorgestrel
All Cause Mortality
	Copper T380 IUD		Levonorgestrel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Copper T380 IUD		Levonorgestrel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/34 (0%)
Other (Not Including Serious) Adverse Events
	Copper T380 IUD		Levonorgestrel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/34 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.