Maintaining Intrauterine Devices (IUDs) in Teens (MINT): A Randomization Trial

• Sponsor: University of Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT00653159
• Collaborator: University of Illinois at Chicago (Other)
• Enrollment: 23
• Locations: 2
• Arms: 2
• Duration (Months): 17.1
• Patients Per Site: 11.5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This is a pilot study to determine the feasibility for a randomized controlled trial of two forms of intrauterine contraception: the Levonorgestrel intrauterine system (LNG-IUS) and the Copper T 380A.

Condition or Disease	Intervention/Treatment	Phase
Contraception	Device: Levonorgestrel-releasing intrauterine device (LNG-IUS); Device: Copper T380A intrauterine device (CuT380A)	Phase 4

Detailed Description

Teenagers have the highest percentage of unintended pregnancies, and often struggle to comply with daily methods of contraception. The intrauterine device (IUD) provides safe, long-term protection and rates highly for patient satisfaction. It also does not require repeat prescriptions or clinic visits, making it a potentially attractive method among teens. However, in adolescent populations, there is both a lack of information about the IUD, as well as few studies that have examined the use of these devices. This study will examine whether a larger scale study on this topic is feasible. IT will address the feasibility of recruiting, consenting, screening, enrolling, randomizing, and retaining adolescents randomized to the LNG-IUS or Copper T 380a.

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Intrauterine Contraception for Adolescents Aged 14 to 18: A Multi-center Randomized Controlled Feasibility Trial of Levonorgestrel-releasing Intrauterine System Compared to the Copper T 380A
• Study Start Date: Jul 1, 2007
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mirena IUD [LNG-IUS] Participants in this arm had a Levonorgestrel-releasing intrauterine device (LNG-IUS), also known as the Mirena IUD, inserted within the first 5 days of the adolescent's menstrual cycle, at least 7 weeks after a vaginal or cesarean delivery or second-trimester abortion or at least 3 weeks after a first-trimester abortion. For participants who had used depot-medroxyprogesterone acetate, insertions occurred at least 6 months after the participant's last injection. Participants were blinded to the device type; however, investigators and research assistants were not.	Device: Levonorgestrel-releasing intrauterine device (LNG-IUS); Teens are randomly assigned to receive the LNG-IUS after completing a screening visit.; Other Names: Mirena IUD
Active Comparator: Paragard IUD [Copper T380A] Participants in this arm had a Copper T380A intrauterine device (CuT380A), also known as the Paragard IUD, inserted within the first 5 days of the adolescent's menstrual cycle, at least 7 weeks after a vaginal or cesarean delivery or second-trimester abortion or at least 3 weeks after a first-trimester abortion. For participants who had used depot-medroxyprogesterone acetate, insertions occurred at least 6 months after the participant's last injection. Participants were blinded to the device type; however, investigators and research assistants were not.	Device: Copper T380A intrauterine device (CuT380A); Teens are randomly assigned to Copper T380 after the screening visit; Other Names: Paraguard IUD

Outcome Measures

Primary Outcome Measures

1. Retention Rate [6 months]

   Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up)

Secondary Outcome Measures

1. Heavy Bleeding Rates [6 months]

   Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A.

2. Pregnancy Rates [6 months]

   Proportion of subjects who became pregnant within 6 months of IUD insertion

3. Expulsion Rates [6 months]

   Rates of partial or complete expulsion for teens randomized to the LNG-IUS or Copper T 380A. Patients experiencing partial expulsion had IUDs visible on speculum exam. Complete expulsion is characterized by complete evacuation of the IUD.

4. Device Satisfaction Rates [6 months]

   Satisfaction rate is the proportion of subjects who report being "happy" or "very happy" with their assigned intrauterine contraceptive method on the date of their 6 month study visit.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 18 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

Healthy, sexually active females age 14 to 18 who:

• Are interested in long term, reversible contraception

• Have regular menstrual cycles (21-35 days)

• Are not planning a pregnancy within the next 6 months

Exclusion Criteria:

Sexually active females age over the age of 18 or who:

• Are not interested in long term, reversible contraception

• Do not have regular menstrual cycles (21-35 days)

• Are planning a pregnancy within the next 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Illinois at Chicago	Chicago	Illinois	United States	60612
2	University of Chicago	Chicago	Illinois	United States	60637

Sponsors and Collaborators

• University of Chicago
• University of Illinois at Chicago

Investigators

• Principal Investigator: Melissa Gilliam, MD, The University of Chicago Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• University of Chicago Section of Family Planning and Contraceptive Research

Publications

None provided.

• Responsible Party: Melissa Gilliam, Professor of Medicine, University of Chicago
• ClinicalTrials.gov Identifier: NCT00653159
• Other Study ID Numbers: 15498A
• First Posted: Apr 4, 2008
• Last Update Posted: Oct 19, 2012
• Last Verified: Oct 1, 2012

• Keywords provided by Melissa Gilliam, Professor of Medicine, University of Chicago: Intrauterine device, contraception, unplanned pregnancy
• Additional relevant MeSH terms: Copper; Levonorgestrel

Study Results

Participant Flow

Recruitment Details	This study was conducted within the Section of Family Planning in the Department of Obstetrics and Gynecology at The University of Chicago and within the Department of Family Medicine at the University of Illinois-Chicago. From December 2007 through June 2008, 37 adolescent females were approached regarding the study.
Pre-assignment Detail	All of the 23 enrolled subjects were ultimately randomized to the treatment arms (12 to LNG-IUS and 11 to CuT380A).

Arm/Group Title	Paragard IUD [CuT380A]	Mirena IUD [LNG-IUS]
Arm/Group Description	Paragard intrauterine device (IUD), Copper T 380A	Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
Period Title: Overall Study
STARTED	11	12
COMPLETED	6	9
NOT COMPLETED	5	3

Baseline Characteristics

Arm/Group Title	Paragard IUD [CuT380A]	Mirena IUD [LNG-IUS]	Total
Arm/Group Description	Paragard intrauterine device (IUD), Copper T 380A	Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System	Total of all reporting groups
Overall Participants	11	12	23
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	17	16.5	16.5
Sex: Female, Male (Count of Participants)
Female	11 100%	12 100%	23 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 9.1%	1 8.3%	2 8.7%
Not Hispanic or Latino	10 90.9%	11 91.7%	21 91.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 9.1%	0 0%	1 4.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	6 54.5%	9 75%	15 65.2%
White	4 36.4%	2 16.7%	6 26.1%
More than one race	0 0%	1 8.3%	1 4.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Education (participants) [Number]
8th grade or less	0 0%	1 8.3%	1 4.3%
Current high school student	8 72.7%	10 83.3%	18 78.3%
High school diploma/GED	2 18.2%	0 0%	2 8.7%
Some college/current college student	1 9.1%	1 8.3%	2 8.7%
Parous (participants) [Number]
Parous	7 63.6%	4 33.3%	11 47.8%
Nulliparous	4 36.4%	8 66.7%	12 52.2%
Previous STI (participants) [Number]
Yes	4 36.4%	2 16.7%	6 26.1%
No	7 63.6%	10 83.3%	17 73.9%
Presence of STI at screening visit (participants) [Number]
Yes	1 9.1%	3 25%	4 17.4%
No	10 90.9%	9 75%	19 82.6%

Outcome Measures

1. Primary Outcome

Title	Retention Rate
Description	Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All study participants were included in the analysis.

Arm/Group Title	Paragard IUD [CuT380A]	Mirena IUD [LNG-IUS]
Arm/Group Description	Paragard intrauterine device (IUD), Copper T 380A	Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
Measure Participants	11	12
Number [percentage of randomized subjects]	55	75

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Paragard IUD [CuT380A], Mirena IUD [LNG-IUS]
	Comments	Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject completed the final study visit at 6 months. Under the null hypothesis, study completion rates are similar for both IUD types.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4003
	Comments
	Method	Fisher Exact
	Comments	Two-sided test

2. Secondary Outcome

Title	Heavy Bleeding Rates
Description	Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All study participants were included in the analysis.

Arm/Group Title	Paragard IUD [CuT380A]	Mirena IUD [LNG-IUS]
Arm/Group Description	Paragard intrauterine device (IUD), Copper T 380A	Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
Measure Participants	11	12
Number [percentage of randomized subjects]	55	33

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Paragard IUD [CuT380A], Mirena IUD [LNG-IUS]
	Comments	Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject experienced heavy bleeding. Under the null hypothesis, heavy bleeding rates are similar for both IUD types.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4136
	Comments
	Method	Fisher Exact
	Comments	Two-sided test

3. Secondary Outcome

Title	Pregnancy Rates
Description	Proportion of subjects who became pregnant within 6 months of IUD insertion
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All study participants were included in the analysis.

Arm/Group Title	Paragard IUD [CuT380A]	Mirena IUD [LNG-IUS]
Arm/Group Description	Paragard intrauterine device (IUD), Copper T 380A	Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
Measure Participants	11	12
Number [percentage of randomized subjects]	9	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Paragard IUD [CuT380A], Mirena IUD [LNG-IUS]
	Comments	Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject became pregnant within 6 months of IUD insertion. Under the null hypothesis, pregnancy rates are similar for both IUD types.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4783
	Comments
	Method	Fisher Exact
	Comments	Two-sided test

4. Secondary Outcome

Title	Expulsion Rates
Description	Rates of partial or complete expulsion for teens randomized to the LNG-IUS or Copper T 380A. Patients experiencing partial expulsion had IUDs visible on speculum exam. Complete expulsion is characterized by complete evacuation of the IUD.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All study participants were included in the analysis.

Arm/Group Title	Paragard IUD [CuT380A]	Mirena IUD [LNG-IUS]
Arm/Group Description	Paragard intrauterine device (IUD), Copper T 380A	Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
Measure Participants	11	12
Number [percentage of randomized subjects]	18	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Paragard IUD [CuT380A], Mirena IUD [LNG-IUS]
	Comments	Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject experienced expulsion of the IUD. Under the null hypothesis, expulsion rates are similar for both IUD types.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2174
	Comments
	Method	Fisher Exact
	Comments	Two-sided test

5. Secondary Outcome

Title	Device Satisfaction Rates
Description	Satisfaction rate is the proportion of subjects who report being "happy" or "very happy" with their assigned intrauterine contraceptive method on the date of their 6 month study visit.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Only subjects who were not lost to follow-up at 6 months were included in this analysis.

Arm/Group Title	Paragard IUD [CuT380A]	Mirena IUD [LNG-IUS]
Arm/Group Description	Paragard intrauterine device (IUD), Copper T 380A	Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
Measure Participants	10	10
Number [percentage of subjects completing study]	80	70

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Paragard IUD [CuT380A], Mirena IUD [LNG-IUS]
	Comments	Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject reported being satisfied ("happy" or "very happy") at the 6 month study visit. Under the null hypothesis, satisfaction rates are similar for both IUD types.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	1.0000
	Comments
	Method	Fisher Exact
	Comments	Two-sided test

Adverse Events

Arm/Group Title	Paragard IUD [CuT380A]		Mirena IUD [LNG-IUS]
Arm/Group Description	Paragard intrauterine device (IUD), Copper T 380A		Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
All Cause Mortality
	Paragard IUD [CuT380A]		Mirena IUD [LNG-IUS]
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Paragard IUD [CuT380A]		Mirena IUD [LNG-IUS]
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Paragard IUD [CuT380A]		Mirena IUD [LNG-IUS]
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/11 (100%)		10/12 (83.3%)
Blood and lymphatic system disorders
Anemia	0/11 (0%)		1/12 (8.3%)
Gastrointestinal disorders
Abdominal pain	1/11 (9.1%)		0/12 (0%)
Bloating	2/11 (18.2%)		2/12 (16.7%)
Vomiting	0/11 (0%)		1/12 (8.3%)
Nausea	0/11 (0%)		1/12 (8.3%)
General disorders
Fatigue	0/11 (0%)		1/12 (8.3%)
Fever	2/11 (18.2%)		3/12 (25%)
Leg pain	0/11 (0%)		1/12 (8.3%)
Infections and infestations
Abscess/infection of Bartholin's gland	0/11 (0%)		1/12 (8.3%)
Bacterial vaginosis	1/11 (9.1%)		0/12 (0%)
Trichomoniasis	0/11 (0%)		1/12 (8.3%)
Urinary tract infection	1/11 (9.1%)		0/12 (0%)
Investigations
Weight gain	1/11 (9.1%)		2/12 (16.7%)
Nervous system disorders
Headaches	1/11 (9.1%)		1/12 (8.3%)
Psychiatric disorders
Libido decreased	1/11 (9.1%)		0/12 (0%)
Psychiatric disorders - Other (Mood Swings)	1/11 (9.1%)		2/12 (16.7%)
Reproductive system and breast disorders
Breast swelling	1/11 (9.1%)		2/12 (16.7%)
Irregular menstruation	1/11 (9.1%)		1/12 (8.3%)
Menorrhagia	5/11 (45.5%)		5/12 (41.7%)
Menstrual pain	11/11 (100%)		5/12 (41.7%)
Vaginal discharge	0/11 (0%)		3/12 (25%)
Vaginal inflammation	0/11 (0%)		1/12 (8.3%)
Skin and subcutaneous tissue disorders
Acne	0/11 (0%)		3/12 (25%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.