MIRENA Â® (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 Â® is indicated for intrauterine contraception for up to 5 years. Thereafter, if continued contraception is desired, the system should be replaced.
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)
Management of Initial Bleeding/Spotting Associated With the Levonorgestrel-releasing Intrauterine System (MIRENA) [Completed]
The purpose of the study is to investigate if the study drugs (tranexamic acid or mefenamic
acid) can control irregular bleeding during the first 3 months of using Mirena. The study
drugs tested are tested against placebo ("dummy medication not containing any active drug").
Treatment period is followed by a one-month period when study drugs are not taken but Mirena
use is continued.
Mirena Post-marketing Surveillance in Japan [Completed]
This study is a regulatory post-marketing surveillance in Japan, and it is a local
prospective and observational study of women who are inserted Mirena for intrauterine
contraception. The objective of this study is to assess safety and effectiveness of Mirena
under real-life practice conditions. A total 550 patients will be recruited and followed for
Pretreatment With Mifepristone Prior to Mirena Insertion [Active, not recruiting]
Hypothesis: Pretreatment with mifeprsitone prior to Mirena placement will induce amenorrhea
and reduce bleeding irrregularities during the initial months of Mirena use.
RCT Novasure Versus Novasure + Mirena IUS in the Treatment of Menorrhagia [Not yet recruiting]
Hypothesis. Combined treatment with novasure and mirena IUS confers benefit over Novasure
alone in the treatment of menorrhagia
A Study Comparing Mirena and Systemic Progestin for Endometrial Hyperplasia [Active, not 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.
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: 2013-02-10