NCT00579475

Brief Summary

Uterine fibroids are a benign but common condition among women in reproductive age. It is one of the most common reasons for hysterectomy since it often causes bleeding problems sometimes leading to anemia. Several alternative treatment regimens have been investigated that could replace surgery. The antiprogesterone, mifepristone, is one of the most promising drugs that have been tested. In addition to the inhibiting effect on the growth of uterine fibroids antiprogestins have been proposed to have an antiproliferative effect on breast tissue. The purpose of the present study is to evaluate the effect of mifepristone on the volume of uterine fibroids. The study will also address the effect of mifepristone on the breast tissue

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2004

Typical duration for phase_1

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 24, 2007

Completed
Last Updated

May 25, 2015

Status Verified

December 1, 2007

Enrollment Period

2.6 years

First QC Date

December 21, 2007

Last Update Submit

May 22, 2015

Conditions

Uterine Fibroids

Keywords

mifepristoneleiomyomasbreast epithelial cell proliferation

Outcome Measures

Primary Outcomes (1)

  • Myoma size

    2004 to 2007

Secondary Outcomes (1)

  • Breast epithelial cell proliferation

    2004 to 2007

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: placebo

I

ACTIVE COMPARATOR

Mifepristone (Mifegyne) 50 mg every other day for 3 months

Drug: Mifegyne

Interventions

MifegyneDRUG

tablets, 50 mg every other day

I
placeboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Uterine fibroids requiring treatment
  • Good general health
  • Willing and able to participate after giving informed consent

You may not qualify if:

  • Need for immediate surgery
  • Concomitant hormonal treatment (HRT)
  • History of malignant disorder of the breast
  • Any contraindication for mifepristone
  • Subjects may be excluded from analysis if one of the following applies:
  • Any violation of the study protocol
  • Lack of essential data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Obstetrics and Gynecology, Karolinska University Hospital

Stockholm, SE17176, Sweden

Location

Related Publications (4)

  • Berger C, Boggavarapu N, Norlin E, Queckborner S, Hornaeus K, Falk A, Engman M, Ramstrom M, Lalitkumar PGL, Gemzell-Danielsson K. Molecular characterization of PRM-associated endometrial changes, PAEC, following mifepristone treatment. Contraception. 2018 Oct;98(4):317-322. doi: 10.1016/j.contraception.2018.05.020. Epub 2018 Jun 8.

    PMID: 29890128DERIVED

  • Engman M, Varghese S, Lagerstedt Robinson K, Malmgren H, Hammarsjo A, Bystrom B, Lalitkumar PG, Gemzell-Danielsson K. GSTM1 gene expression correlates to leiomyoma volume regression in response to mifepristone treatment. PLoS One. 2013 Dec 4;8(12):e80114. doi: 10.1371/journal.pone.0080114. eCollection 2013.

    PMID: 24324590DERIVED

  • Engman M, Granberg S, Williams AR, Meng CX, Lalitkumar PG, Gemzell-Danielsson K. Mifepristone for treatment of uterine leiomyoma. A prospective randomized placebo controlled trial. Hum Reprod. 2009 Aug;24(8):1870-9. doi: 10.1093/humrep/dep100. Epub 2009 Apr 23.

    PMID: 19389793DERIVED

  • Engman M, Skoog L, Soderqvist G, Gemzell-Danielsson K. The effect of mifepristone on breast cell proliferation in premenopausal women evaluated through fine needle aspiration cytology. Hum Reprod. 2008 Sep;23(9):2072-9. doi: 10.1093/humrep/den228. Epub 2008 Jun 24.

    PMID: 18579510DERIVED

MeSH Terms

Conditions

Leiomyoma

Interventions

Mifepristone

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Kristina Gemzell Danielsson, Prof.MD.PHD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2007

First Posted

December 24, 2007

Study Start

November 1, 2004

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

May 25, 2015

Record last verified: 2007-12

Locations

SE(1)