CompletedPhase 2

Pretreatment With Mifepristone Prior to Mirena Insertion

Sweden60 participantsStarted 2013-08

Plain-language summary

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

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Days with bleeding and spotting

Timeframe: During the first 3 months of Mirena use

Trial details

NCT IDNCT01931657

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-12

View on ClinicalTrials.gov More Women in Need of Long Acting Reversibel Cntraception With the Intrauterine Levonorgestrel Releasing System, Mirena trials