most of it makes sense.
if they have not done a trial with women with High Blood pressure than they would not know the full side effects, so to be safe than sorry they said NO.
they just scewed up talking about the doses.
should not be used in kids mean female kids because they have not studied it yet, but they will, here is proof.
http://www.clinicaltrials.gov/ct2/show/NCT00653159?term=mirena&rank=12
Maintaining Intrauterine Devices (IUDs) in Teens (MINT): A Randomization Trial
This study is currently recruiting participants.
Verified by University of Chicago, April 2008
Sponsors and Collaborators: University of Chicago
University of Illinois
Information provided by: University of Chicago
ClinicalTrials.gov Identifier: NCT00653159
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. 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 prescriiptions 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.
Condition Intervention Phase
Contraception
Device: Levonorgestrel-releasing intrauterine device (LNG-IUS) - Mirena IUD
Device: Paraguard (Copper T380A)
Phase IV
MedlinePlus related topics: Birth Control
ChemIDplus related topics: Levonorgestrel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety Study
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
Further study details as provided by University of Chicago:
Primary Outcome Measures:
Feasibility of screening, enrolling, randomizing, and retaining teens in a trial of dissimilar IUDs [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
Bleeding patterns and rates of dysmenorrhea among teens randomized to the LNG-IUS or Copper T 380A. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Rates of expulsion and pregnancy for teens randomized to the LNG-IUS or Copper T 380A. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Quality of life among teens randomized to the LNG-IUS or Copper T 380A [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Estimated Enrollment: 24
Study Start Date: July 2007
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Mirena IUD Device: Levonorgestrel-releasing intrauterine device (LNG-IUS) - Mirena IUD
Teens are randomly assigned to receive the LNG-IUS after completing a screening visit.
2: Active Comparator
Paragard IUD Device: Paraguard (Copper T380A)
Teens are randomly assigned to Copper T380 after the screening visit
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
Contacts
Contact: Amy B Neustadt, MPH 773-834-3890 aneustadt@babies.bsd.uchicago.edu
Contact: Melissa L Gilliam, MD MPH 773-834-0840 mgilliam@babies.bsd.uchicago.edu
Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Amy B Neustadt, MPH 773-834-3890 aneustadt@babies.bsd.uchicago.edu
Contact: Melissa Gilliam, MD, MPH 773-834-0840 mgilliam@babies.bsd.uchicago.edu
Principal Investigator: Melissa Gilliam, MD MPH
Sub-Investigator: Sabrina Holmquist, MD MPH
Sub-Investigator: Lisa Memmel, MD
Sub-Investigator: Sara Mornar, MD
Sub-Investigator: Mishka Terplan, MD MPH
Sub-Investigator: Amy Whitaker, MD
University of Illinois at Chicago Active, not recruiting
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Chicago
University of Illinois
More Information
University of Chicago Section of Family Planning and Contraceptive Research
Responsible Party: University of Chicago ( Melissa Gilliam MD, MPH )
Study ID Numbers: 15498A
First Received: April 1, 2008
Last Updated: April 3, 2008
ClinicalTrials.gov Identifier: NCT00653159
Health Authority: United States: Institutional Review Board
Keywords provided by University of Chicago:
Intrauterine device, contraception, unplanned pregnancy
Study placed in the following topic categories:
Levonorgestrel
Copper
Additional relevant MeSH terms:
Levonorgestrel
Contraceptive Agents
Therapeutic Uses
Growth Substances
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Trace Elements
Reproductive Control Agents
Micronutrients
Pharmacologic Actions
ClinicalTrials.gov processed this record on August 21, 2008