Up-to-date List of Mirena Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Mirena Medical Research Studies

1 Recruiting Pretreatment With Mifepristone Prior to Mirena Insertion
Condition: Women in Need of Long Acting Reversibel Cntraception With the Intrauterine Levonorgestrel Releasing System, Mirena
Interventions: Drug: Mifepristone prior to Mirena;   Drug: Placebo prior to Mirena insertion
Outcome Measures: Days with bleeding and spotting;   Endometrial changes;   Effects on breast tissue
2 Unknown  Levonorgestrel Intrauterine System For Emergency Contraception
Conditions: Pregnancy Prevention;   Emergency Contraception
Interventions: Drug: oral levonorgestrel;   Device: levonorgestrel IUS
Outcome Measures: Pregnancy;   LARC use at 6 months;   Continuation and satisfaction among participants in the LNG-IUS arm
3 Recruiting Study of the Copper IUD or Oral Levonorgestrel and the Levonorgestrel IUD for Women Seeking Emergency Contraception
Condition: Emergency Contraception
Interventions: Drug: Copper IUD;   Drug: Levonorgestrel IUD
Outcome Measures: Pregnancy rates in first month after IUD insertion;   1 Year IUD continuation rates
4 Not yet recruiting RCT Novasure Versus Novasure + Mirena IUS in the Treatment of Menorrhagia
Condition: Menorrhagia
Intervention: Procedure: novasure Mirena IUS combined
Outcome Measure: Quality of life
5 Recruiting BLIS - Breastfeeding Levonorgestrel IUD Study
Condition: Contraception
Intervention: Drug: Levonorgestrel IUD
Outcome Measures: Breastfeeding continuation rates at 8 weeks postpartum;   Lactogenesis Stage 2
6 Unknown  Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding
Conditions: Heavy Menstrual Bleeding;   Menorrhagia;   Hypermenorrhea
Interventions: Drug: Norethindrone acetate pretreatment;   Other: No pretreatment
Outcome Measures: Total number of bleeding days;   Menorrhagia Questionnaire
7 Recruiting Levonorgestrel Intrauterine Device (IUD) to Treat Complex Atypical Hyperplasia (CAH) and Grade 1 Endometrioid Endometrial Carcinoma (G1EEC)
Conditions: Hyperplasia;   Endometrial Cancer
Intervention: Device: Levonorgestrel IUD
Outcome Measure: Complete Regression of Disease
8 Unknown  The Effect of a Levonorgestrel-releasing Intrauterine Device (IUD) Versus a Copper Containing IUD on Risk of Blood Clots
Condition: Blood Coagulation Disorders
Interventions: Device: Levonorgestrel-containing IUD (Mirena®);   Device: Copper-containing IUD (Paraguard®)
Outcome Measures: The primary outcome of this study will be change in coagulation parameters, with sample size calculations powered to detect a 35% change in D-dimer within groups and a 50% difference between groups.;   Patient satisfaction with IUD device;   Difference in bleeding patterns between groups
9 Recruiting Non-interventional Study of Long-term Intrauterine Contraceptives Acceptability and User Satisfaction
Condition: Contraception
Interventions: Drug: Levonorgestrel (Mirena, BAY86-5028);   Device: Copper IUD
Outcome Measures: User satisfaction of the contraception method with Mirena or Copper IUD;   Safety evaluation of Mirena or Copper IUD in routine practice Safety parameters include number of AEs, severity,relationship to Mirena or Cooper IUD;   Contraceptive reliability of Mirena or Cooper IUD in routine practice ( fixing number of pregnancies);   Continuation/discontinuation rate ( number of cases with contraceptive method continuation and discontinuations);   Relationship between different parameters and women preferences in choosing Mirena or Cooper IUD as their contraceptive method ( demographic parameters, age group, residence, reproductive history and plans, etc.) using patients questionnaire
10 Not yet recruiting Megestrol Acetate or Levonorgestrel-Releasing Intrauterine System in Treating Patients With Atypical Endometrial Hyperplasia or Endometrial Cancer
Conditions: Atypical Endometrial Hyperplasia;   Endometrial Adenocarcinoma;   Recurrent Endometrial Carcinoma;   Stage IA Endometrial Carcinoma;   Stage IB Endometrial Carcinoma;   Stage II Endometrial Carcinoma;   Stage IIIA Endometrial Carcinoma;   Stage IIIB Endometrial Carcinoma;   Stage IIIC Endometrial Carcinoma;   Stage IVA Endometrial Carcinoma;   Stage IVB Endometrial Carcinoma
Interventions: Drug: megestrol acetate;   Device: levonorgestrel-releasing intrauterine system;   Other: laboratory biomarker analysis;   Other: questionnaire administration
Outcome Measures: Histologic regression from endometrioid adenocarcinoma or complex atypical hyperplasia to benign endometrium;   Change in weight;   Change in mood ascertained using the self-reported Beck Depression Inventory-Primary Care (BDI-PC);   Compliance
11 Unknown  Levonorgestrel-Intrauterine System (LNG-IUS) Insertion in the Postpartum Period
Condition: Contraception
Intervention: Device: Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)
Outcome Measures: Continuation Rates of the LNG-IUS when placed postpartum at three time periods;   Expulsion rate of the LNG-IUS when placed postpartum at three time periods;   Pain at placement
12 Not yet recruiting Mirena for Contraception In InDian Subjects User continuAtion and Satisfaction Study
Condition: Contraception
Intervention: Drug: Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena)
Outcome Measures: Percentage continuation rate of LNG IUS at end of observation period;   Percentage of Women with user satisfaction scoring somewhat satisfied to very satisfied;   Cumulative discontinuation rate for pregnancy;   Cumulative discontinuation rate for other medical reasons;   Cumulative discontinuation rate for non-medical reasons;   Mean percentage of women with amenorrhea;   Mean percent of women with spotting, inter-menstrual bleeding;   Distribution of contraceptive usage patterns;   Incidence rate of drug-related adverse events
13 Not yet recruiting LNG-IUS Randomized Controlled Trial at 2-3 Weeks Postpartum
Conditions: Contraception;   Malposition of Intrauterine Contraceptive Device
Intervention: Drug: Levonorgestrel Intrauterine System (LNG-IUS)
Outcome Measures: Mean intrauteriune contraception to endometrium (IUC-E) distance difference;   Mean pain experience of LNG-IUS insertion by treatment group measured by visual analog scale;   Proportion of women using the originally inserted LNG-IUS;   Proportion of LNG-IUS expulsions (partial and complete) between the two groups;   Comparison of the percentage of participants that return for their intended LNG-IUS insertion visit
14 Recruiting Comparison of the Levonorgestrel IUD and the Copper IUD Placed in the Immediate Postplacental Period: A Randomized Controlled Trial
Condition: Postplacental IUD Placement
Interventions: Device: Mirena (LNG-IUS);   Device: Paragard (Copper IUD)
Outcome Measures: IUD Expulsion Rate;   Pregnancy;   Complications;   Satisfaction;   IUD position within uterus;   IUD position within the uterus
15 Recruiting Mirena and Estrogen for Control of Perimenopause Symptoms and Ovulation Suppression
Condition: Menopausal and Other Perimenopausal Disorders
Interventions: Drug: Mirena;   Drug: Estradiol;   Drug: Placebo Gel
Outcome Measures: Ovulation;   Hot Flashes;   Sleep;   Depression
16 Recruiting Bleeding Pattern Difference Between Levonorgestrel Intrauterine System (LNG-IUS) and Copper Intrauterine Devices (IUDs) Immediately Inserted After Abortion
Condition: Contraception
Interventions: Drug: Levonorgestrel IUS (Mirena, BAY86-5028);   Device: Copper-IUD
Outcome Measures: The number of bleeding/spotting days assessed over the second 90-day reference period after induced abortion;   Menstrual bleeding intensity;   Abortion related bleeding days;   Time to the first menstrual bleeding following abortion;   Participants continuation rates of Mirena and Cu-IUD;   Reasons for discontinuation of Mirena and Cu-IUD; Participants satisfaction rates of Mirena and Cu-IUD;   Percentage of participants with adverse events
17 Unknown  Topical Lidocaine on the Cervix and Intra-Cervical Prior to Insertion of Intrauterine Devices
Condition: Contraception
Interventions: Drug: Lidocaine;   Drug: Lubricant
Outcome Measure: Determine if topical lidocaine intra-cervically and on the cervix decreases the pain associated with insertion of a Mirena® (levonorgestrel intrauterine device).
18 Recruiting Effects of Obesity on Pharmacokinetics of the Levonorgestrel Emergency Contraceptive Pill
Condition: Obesity
Intervention: Drug: Levonorgestrel 1.5mg by mouth once
Outcome Measures: Maximum concentration (Cmax);   Time to maximum concentration (Tmax);   Minimum concentration (Cmin);   Area under the concentration time-curve (AUC)
19 Recruiting Stopping Heavy Periods Project
Conditions: Abnormal Uterine Bleeding;   Abnormal Uterine Bleeding, Ovulatory Dysfunction;   Abnormal Uterine Bleeding, Endometrial Hemostatic Dysfunction
Interventions: Device: Levonorgestrel intrauterine system;   Drug: Combined oral contraceptives
Outcome Measures: Menstrual Bleeding Questionnaire;   Treatment Failure
20 Recruiting Management of Endometrial Hyperplasia With a LNG-IUS: Multicenter Study: KGOG2006
Condition: Endometrial Hyperplasia
Intervention: Device: Mirena (LNG-IUS)
Outcome Measures: response rate;   consistency of the results between office endometrial aspiration biopsy and dilatation and curettage (D&C) procedure.

These studies may lead to new treatments and are adding insight into Mirena etiology and treatment.

A major focus of Mirena research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.

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