Contraception
Conditions
Keywords
Intrauterine device, contraception, unplanned pregnancy
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.
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.
Interventions
Teens are randomly assigned to receive the LNG-IUS after completing a screening visit.
DEVICECopper T380A intrauterine device (CuT380A)
Teens are randomly assigned to Copper T380 after the screening visit
Sponsors
University of Illinois at Chicago
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 18 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Heavy Bleeding Rates | 6 months | Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A. |
| Pregnancy Rates | 6 months | Proportion of subjects who became pregnant within 6 months of IUD insertion |
| 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. |
| 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. |
Countries
United States
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 details
All of the 23 enrolled subjects were ultimately randomized to the treatment arms (12 to LNG-IUS and 11 to CuT380A).
Participants by arm
| Arm | Count |
|---|---|
| Paragard IUD [CuT380A] Paragard intrauterine device (IUD), Copper T 380A | 11 |
| Mirena IUD [LNG-IUS] Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System | 12 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 |
Baseline characteristics
| Characteristic | Paragard IUD [CuT380A] | Mirena IUD [LNG-IUS] | Total |
|---|---|---|---|
| Age, Continuous | 17 years | 16.5 years | 16.5 years |
| Education 8th grade or less | 0 participants | 1 participants | 1 participants |
| Education Current high school student | 8 participants | 10 participants | 18 participants |
| Education High school diploma/GED | 2 participants | 0 participants | 2 participants |
| Education Some college/current college student | 1 participants | 1 participants | 2 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 11 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Parous Nulliparous | 4 participants | 8 participants | 12 participants |
| Parous Parous | 7 participants | 4 participants | 11 participants |
| Presence of STI at screening visit No | 10 participants | 9 participants | 19 participants |
| Presence of STI at screening visit Yes | 1 participants | 3 participants | 4 participants |
| Previous STI No | 7 participants | 10 participants | 17 participants |
| Previous STI Yes | 4 participants | 2 participants | 6 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 9 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Female | 11 Participants | 12 Participants | 23 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 11 | 10 / 12 |
| serious Total, serious adverse events | 0 / 11 | 0 / 12 |
Outcome results
Primary
Retention Rate
Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up)
Time frame: 6 months
Population: All study participants were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paragard IUD [CuT380A] | Retention Rate | 55 percentage of randomized subjects |
| Mirena IUD [LNG-IUS] | Retention Rate | 75 percentage of randomized subjects |
Comparison: 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.p-value: 0.4003Fisher Exact
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.
Time frame: 6 months
Population: Only subjects who were not lost to follow-up at 6 months were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paragard IUD [CuT380A] | Device Satisfaction Rates | 80 percentage of subjects completing study |
| Mirena IUD [LNG-IUS] | Device Satisfaction Rates | 70 percentage of subjects completing study |
Comparison: 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.p-value: 1Fisher Exact
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.
Time frame: 6 months
Population: All study participants were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paragard IUD [CuT380A] | Expulsion Rates | 18 percentage of randomized subjects |
| Mirena IUD [LNG-IUS] | Expulsion Rates | 0 percentage of randomized subjects |
Comparison: 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.p-value: 0.2174Fisher Exact
Secondary
Heavy Bleeding Rates
Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A.
Time frame: 6 months
Population: All study participants were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paragard IUD [CuT380A] | Heavy Bleeding Rates | 55 percentage of randomized subjects |
| Mirena IUD [LNG-IUS] | Heavy Bleeding Rates | 33 percentage of randomized subjects |
Comparison: 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.p-value: 0.4136Fisher Exact
Secondary
Pregnancy Rates
Proportion of subjects who became pregnant within 6 months of IUD insertion
Time frame: 6 months
Population: All study participants were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paragard IUD [CuT380A] | Pregnancy Rates | 9 percentage of randomized subjects |
| Mirena IUD [LNG-IUS] | Pregnancy Rates | 0 percentage of randomized subjects |
Comparison: 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.p-value: 0.4783Fisher Exact