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Pretreatment With Mifepristone Prior to Mirena Insertion

Information source: Karolinska Institutet
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Women in Need of Long Acting Reversibel Cntraception With the Intrauterine Levonorgestrel Releasing System, Mirena

Intervention: Mifepristone prior to Mirena (Drug); Placebo prior to Mirena insertion (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Karolinska Institutet

Summary

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

Clinical Details

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

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

Primary outcome: Days with bleeding and spotting

Secondary outcome:

Endometrial changes

Effects on breast tissue

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.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Karolinska University Hospital, Stockholm 17176, Sweden
Additional Information

Starting date: August 2013
Last updated: May 15, 2015

Page last updated: August 23, 2015

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