NCT01280045

Brief Summary

The investigators aimed to assess if use of aromatase inhibitors could decrease volume of uterine leiomyoma and cause same percentage of adverse effects during its use compared to GnRH analogs.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 20, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

2.3 years

First QC Date

January 10, 2011

Last Update Submit

August 12, 2020

Conditions

UTERINE LEIOMYOMA

Outcome Measures

Primary Outcomes (1)

  • Operative Time

    Intra-operative time

    Intra-operative

Secondary Outcomes (1)

  • Uterine Leiomyoma Volume

    3 Months After Treatment, During Surgery

Study Arms (2)

AROMATASE INHIBITOR

EXPERIMENTAL

this would be compared before and after VAGINAL HYSTERECTOMY

Procedure: VAGINAL HYSTERECTOMY

GNRH ANALOG

ACTIVE COMPARATOR

this would be compared before and after VAGINAL HYSTERECTOMY

Procedure: VAGINAL HYSTERECTOMY

Interventions

VAGINAL HYSTERECTOMYPROCEDURE

GOSERELINE ACETATE 10.8 MG FOR THREE MONTHS; ANASTROZOL ACETATE FOR THREE MONTHS

Also known as: None declared
AROMATASE INHIBITORGNRH ANALOG

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • WOMEN OVER 40 YEARS, UTERINE VOLUME HIGHER THAN 300 ML, MINIMAL ANATOMIC CONDITIONS FOR VAGINAL SURGERY

You may not qualify if:

  • ACTIVE GYNECOLOGIC MALIGNANCY

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Parsanezhad ME, Azmoon M, Alborzi S, Rajaeefard A, Zarei A, Kazerooni T, Frank V, Schmidt EH. A randomized, controlled clinical trial comparing the effects of aromatase inhibitor (letrozole) and gonadotropin-releasing hormone agonist (triptorelin) on uterine leiomyoma volume and hormonal status. Fertil Steril. 2010 Jan;93(1):192-8. doi: 10.1016/j.fertnstert.2008.09.064. Epub 2009 Jan 9.

    PMID: 19135657RESULT

MeSH Terms

Conditions

Myofibroma

Interventions

Hysterectomy, Vaginal

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

HysterectomyGynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: We woudl be comparing aromatase inhibitors versus GnRH analogs
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Physician, MD, PhD

Study Record Dates

First Submitted

January 10, 2011

First Posted

January 20, 2011

Study Start

January 1, 2011

Primary Completion

May 1, 2013

Study Completion

January 1, 2015

Last Updated

August 13, 2020

Record last verified: 2020-08