Re: Mirena Facts Updated

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 Tweet