Clinical trial NCT01007305: Bilateral Oophorectomy Versus Ovarian Conservation
Official title: Elective Bilateral Salpingo-oophorectomy Versus Ovarian Conservation: A Pilot Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oophorectomy
Hysterectomy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
First posted: 2009-11-04
Enrollment: 20
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a pilot study to assess the feasibility of conducting a randomized, blinded, controlled trial of bilateral salpingo-oophorectomy (BSO, removal of the ovaries and fallopian tubes) versus ovarian conservation among premenopausal women age 40 years and greater who plan to undergo hysterectomy for a benign gynecologic condition. Subjects will be randomized to BSO or ovarian conservation concomitant with hysterectomy and remain blinded to group assignment. The primary goal of this pilot is to determine the feasibility of recruiting and retaining study participants in anticipation of conducting a larger, multi-centered trial. However, the investigators will also obtain baseline data and follow-up measures at 6 weeks and 6 months after surgery. Outcomes will be assessed in several domains that the investigators hypothesize may be effected by oophorectomy: cardiovascular health, skeletal health, sexual functioning, and health-related quality-of-life.


Eligibility criteria: Inclusion Criteria:

1. Plans to undergo hysterectomy for any non-cancerous gynecologic condition, including symptomatic fibroids, abnormal bleeding, pelvic pain, or pelvic organ prolapse. Hysterectomy may be done abdominally, vaginally or laparoscopically
2. Premenopausal defined as having at least one menses in the 3 months prior to surgery
3. Age \> or = 40 years
4. Speaks English or Spanish

Exclusion Criteria:

1. Personal or family history of breast and/or ovarian cancer (at least one first degree relative with a diagnosis of breast or ovarian cancer) or a known BRCA mutation
2. Known or suspected adnexal mass by physical exam or radiologic imaging study
3. Gynecologist recommends BSO for treatment of pelvic pain and/or endometriosis
4. Known history of coronary heart disease defined as any of the following: prior myocardial infarction, history of angioplasty, history of angina, admission to the hospital for evaluation of chest pain, or use of nitroglycerin to treat angina
5. History of stroke
6. History of osteoporosis

Primary outcomes:
measure: Recruitment rate
timeFrame: start of study
measure: Flow-mediated diameter of the brachial artery
timeFrame: Baseline and 6 months follow-up
measure: Serum bone turnover markers
timeFrame: Baseline and 6 months follow-up
measure: Sexual functioning and quality-of-life questionnaires
timeFrame: Baseline and 6 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Francisco
country: United States
facility: University of California, Sans Francisco
state: California
Study officials:
References: