Bilateral Oophorectomy Versus Ovarian Conservation

NCT01007305 | Completed DMC

• 1 other identifier: BSO 01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Oophorectomy; Hysterectomy

Outcome Measures

Primary Outcomes (4)

• Recruitment rate

  start of study

• Flow-mediated diameter of the brachial artery

  Baseline and 6 months follow-up

• Serum bone turnover markers

  Baseline and 6 months follow-up

• Sexual functioning and quality-of-life questionnaires

  Baseline and 6 month follow-up

Study Arms (2)

Bilateral salpingo-oophorectomy

EXPERIMENTAL

Removal of both ovaries and fallopian tubes at the time of hysterectomy for benign conditions.

Procedure: Bilateral salpingo-oophorectomy

Ovarian conservation

ACTIVE COMPARATOR

No ovaries or fallopian tubes removed at the time of hysterectomy for benign conditions.

Procedure: Ovarian conservation

Interventions

Bilateral salpingo-oophorectomy PROCEDURE

Removal of both ovaries and fallopian tubes at the time of hysterectomy

Bilateral salpingo-oophorectomy

Ovarian conservation PROCEDURE

Both ovaries and fallopian tubes not removed at the time of hysterectomy

Ovarian conservation

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Premenopausal defined as having at least one menses in the 3 months prior to surgery
• Age \> or = 40 years
• Speaks English or Spanish

You may not qualify if:

• 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
• Known or suspected adnexal mass by physical exam or radiologic imaging study
• Gynecologist recommends BSO for treatment of pelvic pain and/or endometriosis
• 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
• History of stroke
• History of osteoporosis

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of Alabama at Birmingham: collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Location

University of California, Sans Francisco

San Francisco, California, 94115, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 3, 2009
• First Posted: November 4, 2009
• Study Start: May 1, 2009
• Primary Completion: April 1, 2011
• Last Updated: August 5, 2011

Record last verified: 2009-11

Locations

US (2)