Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Alabama at Birmingham | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral salpingo-oophorectomy | Experimental | Removal of both ovaries and fallopian tubes at the time of hysterectomy for benign conditions. |
|
| Ovarian conservation | Active Comparator | No ovaries or fallopian tubes removed at the time of hysterectomy for benign conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral salpingo-oophorectomy | Procedure | Removal of both ovaries and fallopian tubes at the time of hysterectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | United States | |||
| University of California, Sans Francisco |
Not provided
Not provided
Not provided
Not provided
Not provided
| Ovarian conservation | Procedure | Both ovaries and fallopian tubes not removed at the time of hysterectomy |
|
| San Francisco |
| California |
| 94115 |
| United States |