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COMPLETED NA

Bilateral Oophorectomy Versus Ovarian Conservation

NCT01007305 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • PROCEDURE Bilateral salpingo-oophorectomy
  • PROCEDURE Ovarian conservation

Study Locations (2)

Alabama

  • University of Alabama at Birmingham — Birmingham

California

  • University of California, Sans Francisco — San Francisco

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2009-05
Phase NA

Sponsor

University of California, San Francis

1,574 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01007305

The ClinicalTrials.gov registry entry for NCT01007305 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francis, which has 1,574 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Hysterectomy appearing as the primary indexed condition, and to 2 interventions — of which Bilateral salpingo-oophorectomy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01007305 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Alabama, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01007305 about?

NCT01007305 is a clinical study titled "Bilateral Oophorectomy Versus Ovarian Conservation". 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 f...

What is the current status of trial NCT01007305?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2009-05.

What conditions does trial NCT01007305 study?

This clinical trial studies the following conditions: Hysterectomy, Oophorectomy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01007305?

The interventions under investigation include: Bilateral salpingo-oophorectomy (PROCEDURE), Ovarian conservation (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01007305?

This trial is sponsored by University of California, San Francis, which has 1,574 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01007305 being conducted?

This trial has 2 study locations across Alabama, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial