NCT00898170

Brief Summary

The effect of myoma removal was studied on 28 patients with hypertension and myoma by holter monitoring and erythropoetin level check.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

May 12, 2009

Status Verified

May 1, 2009

Enrollment Period

10 months

First QC Date

May 11, 2009

Last Update Submit

May 11, 2009

Conditions

MyomaHypertension

Keywords

myomahypertensionerythropoetinblood pressureerythropoetin level

Outcome Measures

Primary Outcomes (1)

  • 24 hour holter monitoring of blood pressure

    6 weeks

Secondary Outcomes (1)

  • erythropoetin level

    6 weeks

Study Arms (1)

myoma, with or without hypertension

EXPERIMENTAL

those with myoma with or without hypertension in holter monitoring

Procedure: myoma removal

Interventions

myoma removalPROCEDURE

surgical removal of myoma by hysterectomy

myoma, with or without hypertension

Eligibility Criteria

Age22 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • candidate for myoma removal by hysterectomy
  • operable
  • hysterectomy is indicated

You may not qualify if:

  • patient refusal
  • inoperable patients
  • other secondary cases of hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Ward Shiraz University of Medical Sciences

Shiraz, Fars, 51318, Iran

Location

MeSH Terms

Conditions

MyomaHypertension

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsVascular DiseasesCardiovascular Diseases

Study Officials

  • javad kojuri, M.D.

    Shiraz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 11, 2009

First Posted

May 12, 2009

Study Start

May 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

May 12, 2009

Record last verified: 2009-05

Locations

IR(1)