Status:
COMPLETED
Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB)
Lead Sponsor:
Agency for Healthcare Research and Quality (AHRQ)
Conditions:
Menorrhagia
Uterine Bleeding
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 ...
Detailed Description
The Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB) is a multicenter, randomized clinical trial that assessed the efficacy and effectiveness of hysterectomy versus e...
Eligibility Criteria
Inclusion
- Abnormal uterine bleeding in the absence of structural pathology, pharmacologic agents, IUD use, or systemic disorders of hemostasis that could explain the condition.
Exclusion
- 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
- History of malignancy of vagina, cervix, endometrium, or ovary
- History of complex endometrial hyperplasia or simple hyperplasia with atypia
- Current use of tamoxifen
- \< 6 months since onset of excessive uterine bleeding
- \< 9 months since stopping the use of IUD
- \< 9 months since stopping the use of implantable hormone agent
- \< 18 months since stopping use of Depo-Provera
- \< 6 months of anovulatory DUB after reaching euthyroid status for woman with diagnosis of hypothyroidism
- \< 3 months since pathology results indicate presence of endometrial polyp
- Baseline Gynecologic Examination
- Enlarged (\>= 14 weeks gestational age) uterus
- Focal bleeding of genital, urinary, or gastrointestinal tract
- Ultrasound Examination
- Presence of any submucosal myoma
- Presence of any myoma \>= 3 cm, any location
- Presence of \> 3 myomas, any size or location
- Presence of endometrial polyp(s)
- Malignancy of the vagina, cervix, endometrium, or ovary
- Laboratory and Ancillary Tests
- FSH level in women ages \> 45 years confirming postmenopausal status
- Abnormal urinary tract or gastrointestinal tract imaging related to uterine bleeding
- Evidence of cervical cancer (screened by Pap smear in last 12 months and confirmed by colposcopy)
- Evidence of complex endometrial hyperplasia or simple hyperplasia with atypia or endometrial cancer (endometrial biopsy in last 12 months)
- Any test value inconsistent with a diagnosis of DUB
- Any test values, unlikely to change, compromising patient safety for surgery
- Other
- Any existing medical condition, unlikely to change, putting patient at excessive risk for surgery
- Request for prophylactic bilateral oophorectomy by woman aged \<45 years
- Lack of willingness to comply with study requirements
- Uncooperative behavior
- Any coexisting condition that may influence a patient's ability to comply with participation
- Refusal to allow evaluation or follow-up
- In process of scheduling surgery at time of baseline visit
- Provisional Eligibility Criteria
- Refusal of randomization
- \< 3 months of medical management (excluding GnRH agonist therapy) within the past 2 years
- Ongoing evaluation or treatment for abnormal cervical cytology (including endocervical polyps)
- Gastrointestinal or urinary tract condition unrelated to uterine bleeding currently being treated
- Any temporary test value compromising patient safety
- Any temporary existing medical condition putting patient at excessive risk from surgery
- Any coexisting condition requiring surgery (except tubal occlusion for any woman or oophorectomy for women \>= 45 years of age)
- Lack of willingness to proceed with surgery at this time
- Lack of willingness to proceed with surgery likely to result in infertility
Key Trial Info
Start Date :
November 1 1997
Trial Type :
INTERVENTIONAL
End Date :
January 1 2004
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT00114088
Start Date
November 1 1997
End Date
January 1 2004
Last Update
June 24 2005
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