NCT00114088

Brief Summary

STOP-DUB is a multicenter randomized clinical trial that is assessing the efficacy and effectiveness of hysterectomy versus endometrial ablation (EA) for dysfunctional uterine bleeding (DUB) in women for whom medical management has not provided relief.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
242

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 1997

Longer than P75 for phase_3

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, 1997

Completed
6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 14, 2005

Completed
Last Updated

June 24, 2005

Status Verified

June 1, 2005

First QC Date

June 13, 2005

Last Update Submit

June 23, 2005

Conditions

MenorrhagiaUterine Bleeding

Keywords

Hysterectomy,Endometrial ablation,Ovulatory dysfunctional uterine bleeding,Anovulatory dysfucntional uterine bleeding,DUBDysfunctional uterine bleeding

Outcome Measures

Primary Outcomes (3)

  • Randomized trial: Impact of surgery on bleeding, pain,

  • fatigue, and major problem (symptom) leading the woman to seek treatment for her condition.

  • Observational study: changes over time in treatment selected, DUB-related symptoms, and quality of life.

Secondary Outcomes (1)

  • Randomized trial: Impact of surgery on primary outcomes at time points after 1 year, quality of life, activity limitation, sexual functioning, urinary incontinence, surgical complications, additional surgery, resource utilization.

Interventions

hysterectomyPROCEDURE
endometrial ablationPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Abnormal uterine bleeding in the absence of structural pathology, pharmacologic agents, IUD use, or systemic disorders of hemostasis that could explain the condition.

You may not qualify if:

  • Prescreen
  • Age \< 18 years
  • Postmenopausal status (or bilateral oophorectomy)
  • Bleeding not considered excessive by woman
  • Desire to retain fertility
  • Refusal to consider surgery
  • Known myoma (from prior examination)
  • Eligibility Screen
  • Lack of willingness to have a gynecologic or ultrasound examination
  • Lack of willingness to be interviewed about bleeding or consider study
  • Pregnancy
  • Prior endometrial resection or ablation
  • Prior myomectomy, myolysis, or hysterectomy
  • Medical History
  • No tentative diagnosis of DUB
  • +43 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Dickersin K, Munro M, Langenberg P, Scherer R, Frick KD, Weber AM, Johns A, Peipert JF, Clark M; Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding Research Group. Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB): design and methods. Control Clin Trials. 2003 Oct;24(5):591-609. doi: 10.1016/s0197-2456(03)00023-0.

    PMID: 14500057BACKGROUND

  • Weber AM, Munro MG. Endometrial ablation versus hysterectomy: STOP-DUB. Medscape Womens Health. 1998 May;3(3):3.

    PMID: 9732095BACKGROUND

  • Frick KD, Clark MA, Steinwachs DM, Langenberg P, Stovall D, Munro MG, Dickersin K; STOP-DUB Research Group. Financial and quality-of-life burden of dysfunctional uterine bleeding among women agreeing to obtain surgical treatment. Womens Health Issues. 2009 Jan-Feb;19(1):70-8. doi: 10.1016/j.whi.2008.07.002.

    PMID: 19111789DERIVED

  • Dickersin K, Munro MG, Clark M, Langenberg P, Scherer R, Frick K, Zhu Q, Hallock L, Nichols J, Yalcinkaya TM; Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB) Research Group. Hysterectomy compared with endometrial ablation for dysfunctional uterine bleeding: a randomized controlled trial. Obstet Gynecol. 2007 Dec;110(6):1279-89. doi: 10.1097/01.AOG.0000292083.97478.38.

    PMID: 18055721DERIVED

MeSH Terms

Conditions

MenorrhagiaUterine HemorrhageMetrorrhagia

Interventions

HysterectomyEndometrial Ablation Techniques

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation Disturbances

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, OperativeAblation Techniques

Study Officials

  • Kay Dickersin, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

June 13, 2005

First Posted

June 14, 2005

Study Start

November 1, 1997

Study Completion

January 1, 2004

Last Updated

June 24, 2005

Record last verified: 2005-06