Pretreatment With Mifepristone Prior to Mirena Insertion

Women in Need of Long Acting Reversibel Cntraception With the Intrauterine Levonorgestrel Releasing System, Mirena Clinical Trial

— MiMi  

Official title:

Pre-treatment With Mifepristone in Patients With Mirena for Optimizing Bleeding Pattern in Pre-menopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01931657
• Other study ID #: W2009M
• Status: Completed
• Phase: Phase 2
• First received: August 25, 2013
• Last updated: February 24, 2016
• Start date: August 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Women in Need of Long Acting Reversibel Cntraception With the Intrauterine Levonorgestrel Releasing System, Mirena

Intervention

Drug:
• Mifepristone prior to Mirena

• Placebo prior to Mirena insertion

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days with bleeding and spotting	To study the effect of pre-treatment with mifepristone on the initial bleeding pattern in women using LNG-IUS (Mirena)	During the first 3 months of Mirena use	No
Secondary	Endometrial changes	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).	3 months post Mirena insertion	Yes
Secondary	Effects on breast tissue	Breast biopsies are obtained at baseline and following 2 months treatment with mifepristone	Evaluated at end of mifeprsitone treatment	Yes