MIRENA ® (levonorgestrel-releasing intrauterine system) consists of a T-shaped polyethylene frame (T-body) with a steroid reservoir (hormone elastomer core) around the vertical stem. The reservoir consists of a cylinder, made of a mixture of levonorgestrel and silicone (polydimethylsiloxane), containing a total of 52 mg levonorgestrel. The reservoir is covered by a silicone (polydimethylsiloxane) membrane. The T-body is 32 mm in both the horizontal and vertical directions. The polyethylene of the T-body is compounded with barium sulfate, which makes it radiopaque. A monofilament brown polyethylene removal thread is attached to a loop at the end of the vertical stem of the T-body.
MIRENA ® is indicated for intrauterine contraception for up to 5 years. Thereafter, if continued contraception is desired, the system should be replaced.
Media Articles Related to Mirena (Levonorgestrel)
First dual-protection intravaginal ring design shows promise in long-term HIV & pregnancy prevention
Source: Clinical Trials / Drug Trials News From Medical News Today [2013.11.12]
A new intravaginal ring (IVR) has been developed for the sustained 90-day co-delivery of tenofovir and levonorgestrel, an anti-human immunodeficiency virus (HIV) drug and a contraceptive. Tenofovir is the only topical prophylactic shown to be effective at reducing the sexual transmission of HIV when formulated in a gel.
New technology combining contraception, HIV and herpes simplex virus-2 prevention
Source: Sexual Health / STDs News From Medical News Today [2013.11.14]
CONRAD Head of drug delivery, Meredith Clark, PhD, presented preclinical data on a new intravaginal ring that provides contraception as well as HIV-1 and HSV-2 prevention at the 2013 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition in San Antonio, Texas.
Contraception needed 3 weeks after giving birth, new mums warned
Source: Fertility News From Medical News Today [2013.10.23]
Fertility can return much more rapidly than many women assume after giving birth, and myths still abound about what contraception can and can't be used while breastfeeding.
Published Studies Related to Mirena (Levonorgestrel)
An overview of four studies of a continuous oral contraceptive (levonorgestrel 90
mcg/ethinyl estradiol 20 mcg) on premenstrual dysphoric disorder and premenstrual
and premenstrual syndrome (PMS)... CONCLUSIONS: These data, although not consistent, indicate that continuous LNG/EE
Ethinyl estradiol and levonorgestrel pharmacokinetics with a low-dose transdermal contraceptive delivery system, AG200-15: a randomized controlled trial. [2011.11.29]
BACKGROUND: This study evaluated the ethinyl estradiol (EE) and levonorgestrel (LNG) pharmacokinetic profiles of AG200-15, a transdermal contraceptive delivery system, compared with a combination oral contraceptive (COC) containing EE 35 mcg and norgestimate 250 mcg... CONCLUSIONS: EE and LNG daily exposure during AG200-15 treatment was within the range reported for a low-dose COC. The daily EE dose with AG 200-15 was equivalent to a 30-mcg COC and was safe and well tolerated. Copyright (c) 2011 Elsevier Inc. All rights reserved.
Naproxen or estradiol for bleeding and spotting with the levonorgestrel intrauterine system: a randomized controlled trial. [2011.09.24]
OBJECTIVE: The purpose of this study was to evaluate whether oral naproxen or transdermal estradiol decreases bleeding and spotting in women who are initiating the levonorgestrel-releasing intrauterine system... CONCLUSION: The administration of naproxen resulted in a reduction in bleeding and spotting days compared with placebo. Copyright A(c) 2011 Mosby, Inc. All rights reserved.
Immediate versus delayed insertion of the levonorgestrel-releasing intrauterine device following dilation and evacuation: a randomized controlled trial. [2011.09.13]
BACKGROUND: The study was conducted to compare 6-month usage of the levonorgestrel-releasing intrauterine device (LNG-IUD) when placed immediately or 3 to 6 weeks after dilation and evacuation (D&E) procedure... CONCLUSION: Significantly more participants had the LNG-IUD placed in the immediate insertion group compared with the delayed insertion group. Given the low risk of complications, immediate post-D&E insertion of the LNG-IUD should be offered, especially for populations that may have difficulty returning for follow-up. Copyright (c) 2011 Elsevier Inc. All rights reserved.
Efficacy and safety of a levonorgestrel enteric-coated tablet as an over-the-counter drug for emergency contraception: a Phase IV clinical trial. [2011.09]
BACKGROUND: An enteric-coated levonorgestrel emergency contraceptive pill (E-LNG-ECP) is an improved formulation, in terms of side effects, which both dissolves and is absorbed in the intestine. Our aim was to evaluate the efficacy and safety of E-LNG-ECP as an over-the-counter (OTC) drug for emergency contraception (EC) in Chinese women... CONCLUSIONS: The study found that E-LNG-ECP was effective, safe and well tolerated as an OTC drug. However, an randomized controlled trial should be performed to compare standard LNG tablets with E-LNG-ECP.
Clinical Trials Related to Mirena (Levonorgestrel)
Mirena Efficiency and Tolerability During the First Year of Use [Completed]
In this trial the efficacy and safety of Mirena was investigated during the first year of
A Study Comparing Mirena and Systemic Progestin for Endometrial Hyperplasia [Recruiting]
Randomized controlled multi-center study with three arms including 200 patients with low
risk endometrial hyperplasia. After confirmed diagnosis the patients will receive one of the
1. Provera (Medroxyprogesterone (MPA)/progestin) 10 mg per oral treatment for 6 months 10
day each cycle,
2. MPA 10 mg continuously for 6 months,
3. Mirena (Levonorgestrel) impregnated IUD for 6 months.
Postplacental or Delayed Insertion of the Levonorgestrel-IUD After Vaginal Delivery [Active, not recruiting]
This study is a randomized controlled trial comparing 6 month usage rates of the
levonorgestrel-releasing intrauterine device (LNG-IUD) when inserted postplacentally after
vaginal delivery or delayed placement at 6-8 weeks postpartum. Given the high rate of
unintended pregnancy in the United States, particularly in postpartum women, there is a need
for reliable, effective, long-term contraception such as the IUD in postpartum women.
Postplacental insertion of intrauterine contraception would help to address this need. The
primary hypothesis of this study is that use of the LNG-IUD at 6 months after vaginal
delivery will be higher in women who have immediate postplacental insertion as compared to
delayed insertion 6-8 weeks following delivery.
Mirena Intrauterine System Timing of Insertion: A Randomized Controlled Trial [Recruiting]
In order to determine the timing of LNG-IUS insertion that results in a greater proportion
of women using the LNG-IUS at 6-months post-partum, we will perform a randomized control
trial of interval versus immediate post-placenta insertion. Women will be enrolled at
36-weeks gestation and greater. At the time of vaginal delivery, women will be randomized
to receive either immediate post-placenta insertion of the LNG-IUS or routine insertion at
4-8 weeks post-partum. All patients will return at 4-6 weeks post-insertion and 6 months
post-partum to confirm correct position of the LNG-IUS. The primary outcome of this
sub-study is the number of LNG-IUS in the correct position at 6-months. Secondary outcomes
include assessing the safety of post-placental LNG-IUS insertion and difference in
acceptability and symptoms experienced by participants. This is a sub-study of the
Contraceptive Choice Project, a prospective cohort study that aims to improve the use of
long-acting contraception by removing financial barriers which has already enrolled over
5,000 patients. Association of this study with CHOICE offers unique advantages including
infrastructure to support subject recruitment, retention and completion of follow-up as well
as covering the cost of LNG-IUS devices.
We hypothesize that, despite higher expulsion rates, women randomized to receive the LNG-IUS
immediately after placenta delivery will have higher rates of LNG-IUS continuation due to
poor rates of follow up in the interval insertion group. This is likely to be particularly
noticeable in our patient population, which is largely uninsured with poor access to
healthcare. Further, typical symptoms of LNG-IUS insertion include bleeding and cramping,
which may be disguised by the post-partum period. Published reports of immediate
post-placenta insertion focus on expulsion rates and do not report on symptoms and
Levonorgestrel Intrauterine System For Emergency Contraception [Recruiting]
Unintended pregnancy rates in the United States are among the highest of developed nations.
These high rates can largely be attributed to incorrect or under contraception of women. One
focus of decreasing unintended pregnancy and abortion rates has centered on expanding access
to and use of long acting reversible contraceptive (LARC) methods which include intrauterine
devices (IUDs), and subdermal implants. Emergency contraception, or post-coital
contraception, offers significant reductions in the chance of pregnancy following an act of
unprotected or under-protected vaginal intercourse. The most common method of emergency
contraception used in the United States is the oral levonorgestrel regimen which reduces
pregnancy risk by up to 89%. More effective, but rarely used, is the Cu T-380 intrauterine
device. The intrauterine device has the added benefit of providing extended contraceptive
use beyond the single episode of unprotected intercourse. The Cu-T380 has been associated
with heavier and more crampy menses however, likely dissuading women from use. Among all IUD
users, the levonorgestrel IUS has gained popularity over the Cu-T380, perhaps because it
offers the potential to improve menstrual related symptoms. There is no data however on the
efficacy of the levonorgestrel IUS as a form of emergency contraception. The purpose of this
study is to evaluate the efficacy of the LNG-IUS as a method of emergency contraception.
Participants will be randomized to receive either the most common method, oral
levonorgestrel, or the LNG-IUS. Participants will then be evaluated 5-6 weeks following
method allocation for pregnancy. Lastly, participants will be asked to complete a telephone
survey 6 months following method allocation assessing their use of a consistent
contraceptive method, their satisfaction with their contraceptive method, any use of
emergency contraception since their enrollment in the study, and lastly any unintended
pregnancies experienced since enrollment in the study. If we could show that the
levonorgestrel IUS is as effective as the most commonly prescribed method of emergency
contraception, we would be introducing another opportunity for LARC initiation and
subsequently impacting unintended pregnancy and abortion rates.
Reports of Suspected Mirena (Levonorgestrel) Side Effects
Device Expulsion (4424),
Device Dislocation (1921),
Abdominal Pain (789),
Vaginal Haemorrhage (787),
Pregnancy With Contraceptive Device (664),
Genital Haemorrhage (629),
Procedural Pain (470),
Uterine Perforation (424),
Amenorrhoea (402), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 1 ratings/reviews, Mirena has an overall score of 3. The effectiveness score is 10 and the side effect score is 4. The scores are on ten point scale: 10 - best, 1 - worst.
Mirena review by 31 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || Severe Side Effects|
|Condition / reason:|| || birth control|
|Dosage & duration:|| || standard (dosage frequency: one time insertion good for five years) for the period of 3 years|
|Other conditions:|| || n/a|
|Other drugs taken:|| || n/a|
|Benefits:|| || the treatment benefits were that i did not get pregnant nor did i get a period. occasional spotting but nothing a pantiliner couldn't handle.|
|Side effects:|| || the side effects are individual and unfortunately you don't know which ones will effect you the most. my personal side effects were horrible acne, weight gain, hair loss, extreme irritability.|
|Comments:|| || just like with any iud you wait for your menstrual cycle to start and have the device inserted then. this was three months after my children were born. approximately one month later i started noticing that my skin was starting to break out really bad, especially on my mid face down, neck, chest and back. i was getting very large cysts which i never had even as a kid. normal zits every now and then but never ones that would leave a scar. when treatments and products wouldn't help i called my obgyn and they told me that was "a common side effect, sorry." well over the course of the next few months i stopped getting a period but would know when my period should've been here because my mood swings were out of control. i would get so angry over nothing. and the next day i would get some cramping. i started keeping track of this and realized that these episodes were happening about every four weeks or so. i also have never felt so bloated and swollen in my life. i sometimes wake up and my fingers don't have any lines on the knuckles. exercise helps this, but i still can't seem to lose those "last 10" pounds. i've spoken to other women who have similiar if not worse effects than me. but the consensus is always that something negative happened after they got it. |
Page last updated: 2013-11-14