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| Name | Class |
|---|---|
| University of Illinois at Chicago | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirena IUD [LNG-IUS] | Active Comparator | 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. |
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| Paragard IUD [Copper T380A] | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel-releasing intrauterine device (LNG-IUS) | Device | Teens are randomly assigned to receive the LNG-IUS after completing a screening visit. |
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| Measure | Description | Time Frame |
|---|---|---|
| Retention Rate | Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Heavy Bleeding Rates | Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A. | 6 months |
| Pregnancy Rates | Proportion of subjects who became pregnant within 6 months of IUD insertion |
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Inclusion Criteria:
Healthy, sexually active females age 14 to 18 who:
Exclusion Criteria:
Sexually active females age over the age of 18 or who:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Gilliam, MD | The University of Chicago Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States | ||
| University of Chicago |
All of the 23 enrolled subjects were ultimately randomized to the treatment arms (12 to LNG-IUS and 11 to CuT380A).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paragard IUD [CuT380A] | Paragard intrauterine device (IUD), Copper T 380A |
| FG001 | Mirena IUD [LNG-IUS] | Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Paragard IUD [CuT380A] | Paragard intrauterine device (IUD), Copper T 380A |
| BG001 | Mirena IUD [LNG-IUS] | Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Retention Rate | Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up) | All study participants were included in the analysis. | Posted | Number | percentage of randomized subjects | 6 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paragard IUD [CuT380A] | Paragard intrauterine device (IUD), Copper T 380A |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment | Disorder characterized by reduction in the amt of hemoglobin in 100 ml of blood. Signs/symptoms may include pallor of the skin and mucous membranes, shortness of breath, palpitations of the heart, soft systolic murmurs, lethargy, and fatigability. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sydeaka Watson, PhD | The University of Chicago Department of Health Studies, Biostatistics Laboratory | 773-834-2378 | swatson@health.bsd.uchicago.edu |
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| Copper T380A intrauterine device (CuT380A) | Device | Teens are randomly assigned to Copper T380 after the screening visit |
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| 6 months |
| Expulsion Rates | 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. | 6 months |
| Device Satisfaction Rates | 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. | 6 months |
| Chicago |
| Illinois |
| 60637 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Education | Number | participants |
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| Parous | A parous female participant has given birth one or more times. A female is nulliparous if she has never given birth. | Number | participants |
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| Previous STI | Number of participants who have previously tested positive for one or more of the following sexually transmitted infections (STI) during the screening visit: chlamydia, gonorrhea, trichomonas, and vaginal warts. | Number | participants |
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| Presence of STI at screening visit | Number of participants who tested positive for one or more of the following sexually transmitted infections (STI) during the screening visit: chlamydia, gonorrhea, trichomonas, and vaginal warts. | Number | participants |
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| Units | Counts |
|---|
| Participants |
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| Secondary | Heavy Bleeding Rates | Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A. | All study participants were included in the analysis. | Posted | Number | percentage of randomized subjects | 6 months |
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| Secondary | Pregnancy Rates | Proportion of subjects who became pregnant within 6 months of IUD insertion | All study participants were included in the analysis. | Posted | Number | percentage of randomized subjects | 6 months |
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| Secondary | Expulsion Rates | 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. | All study participants were included in the analysis. | Posted | Number | percentage of randomized subjects | 6 months |
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| Secondary | Device Satisfaction Rates | 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. | Only subjects who were not lost to follow-up at 6 months were included in this analysis. | Posted | Number | percentage of subjects completing study | 6 months |
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| 0 |
| 11 |
| 11 |
| 11 |
| EG001 | Mirena IUD [LNG-IUS] | Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System | 0 | 12 | 10 | 12 |
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| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | A disorder characterized by a sensation of marked discomfort in the abdominal region. |
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| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | A disorder characterized by subject-reported feeling of uncomfortable fullness of the abdomen. |
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| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | A disorder characterized by the reflexive act of ejecting the contents of the stomach through the mouth. |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | A disorder characterized by a queasy sensation and/or the urge to vomit. |
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| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment | A disorder characterized by a state of generalized weakness with a pronounced inability to summon sufficient energy to accomplish daily activities. |
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| Fever | General disorders | CTCAE (4.0) | Systematic Assessment | A disorder characterized by elevation of the body's temperature above the upper limit of normal. |
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| Leg pain | General disorders | Systematic Assessment | Pain in the leg. |
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| Abscess/infection of Bartholin's gland | Infections and infestations | Systematic Assessment | Abscess/infection of Bartholin's gland |
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| Bacterial vaginosis | Infections and infestations | Systematic Assessment | Bacterial vaginosis is the name of a condition in women where the normal balance of bacteria in the vagina is disrupted and replaced by an overgrowth of certain bacteria. It is sometimes accompanied by discharge, odor, pain, itching, or burning. |
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| Trichomoniasis | Infections and infestations | Systematic Assessment | Trichomoniasis (or "trich") is a very common sexually transmitted disease (STD) that is caused by infection with a protozoan parasite called Trichomonas vaginalis. |
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| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment | A disorder characterized by an infectious process involving the urinary tract, most commonly the bladder and the urethra |
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| Weight gain | Investigations | CTCAE (4.0) | Systematic Assessment | A finding characterized by an increase in overall body weight; for pediatrics, greater than the baseline growth curve. |
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| Headaches | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | A disorder characterized by a sensation of marked discomfort in various parts of the head, not confined to the area of distribution of any nerve |
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| Libido decreased | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment | A disorder characterized by a decrease in sexual desire. |
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| Psychiatric disorders - Other (Mood Swings) | Psychiatric disorders | Systematic Assessment | A mood swing is an extreme or rapid change in mood. |
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| Breast swelling | Reproductive system and breast disorders | Systematic Assessment | Swelling and tenderness of the breasts |
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| Irregular menstruation | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment | A disorder characterized by irregular cycle or duration of menses |
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| Menorrhagia | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment | A disorder characterized by abnormally heavy vaginal bleeding during menses. |
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| Menstrual pain | Reproductive system and breast disorders | Systematic Assessment | Pain during menses |
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| Vaginal discharge | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment | A disorder characterized by vaginal secretions. Mucus produced by the cervical glands is discharged from the vagina naturally, especially during the childbearing years. |
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| Vaginal inflammation | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment | A disorder characterized by inflammation involving the vagina. Symptoms may include redness, edema, marked discomfort and an increase in vaginal discharge |
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| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment | Acne is a common human skin disease, characterized by areas of skin with seborrhea (scaly red skin), comedones (blackheads and whiteheads), papules (pinheads), pustules (pimples), nodules (large papules) and possibly scarring. |
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