Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB)

Inclusion Criteria:

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

Exclusion Criteria: 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 diagnosisof 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 bycolposcopy)

• Evidence of complex endometrial hyperplasia or simple hyperplasia with atypia orendometrial 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 riskfor 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 withparticipation

• 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 2years

• Ongoing evaluation or treatment for abnormal cervical cytology (including endocervicalpolyps)

• Gastrointestinal or urinary tract condition unrelated to uterine bleeding currentlybeing treated

• Any temporary test value compromising patient safety

• Any temporary existing medical condition putting patient at excessive risk fromsurgery

• Any coexisting condition requiring surgery (except tubal occlusion for any woman oroophorectomy 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