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Pretreatment With Mifepristone Prior to Mirena Insertion (MiMi)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01931657
Recruitment Status : Completed
First Posted : August 29, 2013
Last Update Posted : February 25, 2016
Information provided by (Responsible Party):
Kristina Gemzell Danielsson, Karolinska Institutet

Brief Summary:
Hypothesis: Pretreatment with mifeprsitone prior to Mirena placement will induce amenorrhea and reduce bleeding irrregularities during the initial months of Mirena use.

Condition or disease Intervention/treatment Phase
Women in Need of Long Acting Reversibel Cntraception With the Intrauterine Levonorgestrel Releasing System, Mirena Drug: Mifepristone prior to Mirena Drug: Placebo prior to Mirena insertion Phase 2

Detailed Description:

The levonorgestrel releasing intrauterine system (IUS), Mirena, represents a highly effective contraceptive method that is cost-effective and requires limited patient effort. Furthermore Mirena offers numerous noncontraceptive benefits and addresses different medical needs for women in reproductive and non reproductive age. Side effects such as menstrual abnormalities are important reasons for early discontinuation of a contraceptive method. Irregular bleeding pattern and spotting represents a well known adverse effect during the first months of use with Mirena and corresponds to the most important factor that negatively influences the acceptability of the IUS. Up to today no standard treatment has been suggested to resolve this issue.

By inducing amenorrhea within a short period of treatment with an anti-progesterone, mifepristone, prior to insertion of Mirena, the bleeding irregularities during the first months of use might be reduced and could therefore represent an important strategy for increasing acceptability of this contraceptive system.

The purpose of the present study is to evaluate the bleeding pattern during the first months of use of Mirena in patients treated with mifepristone compared to placebo in women using Mirena for contraception. The study will also address the effect of mifepristone on endometrial morphology and breast tissue.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pre-treatment With Mifepristone in Patients With Mirena for Optimizing Bleeding Pattern in Pre-menopausal Women
Study Start Date : August 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Mifepristone prior to Mirena
Pretreatment with mifepristone prior to Mirena insertion
Drug: Mifepristone prior to Mirena
Other Name: Mifepristone

Placebo Comparator: Placebo prior to Mirena
Pretreatment with placebo prior to Mirena insertion
Drug: Placebo prior to Mirena insertion

Primary Outcome Measures :
  1. Days with bleeding and spotting [ Time Frame: During the first 3 months of Mirena use ]
    To study the effect of pre-treatment with mifepristone on the initial bleeding pattern in women using LNG-IUS (Mirena)

Secondary Outcome Measures :
  1. Endometrial changes [ Time Frame: 3 months post Mirena insertion ]
    To study the effect of mifepristone pre treatment on the endometrium in women before and during treatment with Mirena with special regard to progesteron receptor modulator associated endometrial changes observed following continuos treatment with mifeprsitone (PAEC).

  2. Effects on breast tissue [ Time Frame: Evaluated at end of mifeprsitone treatment ]
    Breast biopsies are obtained at baseline and following 2 months treatment with mifepristone

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion criteria:

  • Pre-menopausal women, >/= 18 years of age.
  • Desire of Mirena for contraception
  • Good general health (as judged by; general physical examination
  • Willing and able to participate after giving informed consent

Exclusion criteria:

  • Any hormonal treatment or IUD use within 2 months prior to study start
  • History of malignant disorder of the breast
  • Any contraindication to mifepristone
  • Pregnancy or breast feeding within 2 months prior to study start

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01931657

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Karolinska University Hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska Institutet

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Responsible Party: Kristina Gemzell Danielsson, Professor, Karolinska Institutet Identifier: NCT01931657    
Other Study ID Numbers: W2009M
First Posted: August 29, 2013    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016
Keywords provided by Kristina Gemzell Danielsson, Karolinska Institutet:
Hormonal effects in the breast
Additional relevant MeSH terms:
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Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents