Maintaining Intrauterine Devices (IUDs) in Teens (MINT): A Randomization Trial
This study has been completed.
Sponsor:
University of Chicago
Collaborator:
University of Illinois
Information provided by (Responsible Party):
Melissa Gilliam, University of Chicago
ClinicalTrials.gov Identifier:
NCT00653159
First received: April 1, 2008
Last updated: October 17, 2012
Last verified: October 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Contraception |
Device: Levonorgestrel-releasing intrauterine device (LNG-IUS) Device: Copper T380A intrauterine device (CuT380A) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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 |
Resource links provided by NLM:
Further study details as provided by University of Chicago:
Primary Outcome Measures:
- Retention Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up)
Secondary Outcome Measures:
- Heavy Bleeding Rates [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A.
- Pregnancy Rates [ Time Frame: 6 months ] [ Designated as safety issue: No ]Proportion of subjects who became pregnant within 6 months of IUD insertion
- Expulsion Rates [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
| Enrollment: | 23 |
| Study Start Date: | July 2007 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: Paraguard IUD
|
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.
Eligibility| Ages Eligible for Study: | 14 Years to 18 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653159
Locations
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612 | |
Sponsors and Collaborators
University of Chicago
University of Illinois
Investigators
| Principal Investigator: | Melissa Gilliam, MD | The University of Chicago Medicine |
More Information
Additional Information:
No publications provided
| Responsible Party: | Melissa Gilliam, Professor of Medicine, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00653159 History of Changes |
| Other Study ID Numbers: | 15498A |
| Study First Received: | April 1, 2008 |
| Results First Received: | September 18, 2012 |
| Last Updated: | October 17, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Chicago:
|
Intrauterine device, contraception, unplanned pregnancy |
Additional relevant MeSH terms:
|
Copper Levonorgestrel Medroxyprogesterone Acetate Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Contraceptive Agents, Female |
Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Male Antineoplastic Agents, Hormonal Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 16, 2013