NCT01931657

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 25, 2016

Status Verified

February 1, 2016

Enrollment Period

2.3 years

First QC Date

August 25, 2013

Last Update Submit

February 24, 2016

Conditions

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

Keywords

LNG-IUSMirenaContraceptionBleedingHormonal effects in the breast

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Endometrial changes

    3 months post Mirena insertion

  • Effects on breast tissue

    Evaluated at end of mifeprsitone treatment

Study Arms (2)

Mifepristone prior to Mirena

EXPERIMENTAL

Pretreatment with mifepristone prior to Mirena insertion

Drug: Mifepristone prior to Mirena

Placebo prior to Mirena

PLACEBO COMPARATOR

Pretreatment with placebo prior to Mirena insertion

Drug: Placebo prior to Mirena insertion

Interventions

Mifepristone prior to MirenaDRUG
Also known as: Mifepristone
Mifepristone prior to Mirena
Placebo prior to Mirena insertionDRUG
Placebo prior to Mirena

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Mifepristone

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 25, 2013

First Posted

August 29, 2013

Study Start

August 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 25, 2016

Record last verified: 2016-02

Locations

SE(1)