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IUD Uterine Vascularization and Side Effects

This study has been completed.
Sponsor:
Collaborators:
UFRGS
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00489463
First received: June 19, 2007
Last updated: June 20, 2007
Last verified: January 2006
History of Changes
  Purpose

The aim of this study was to evaluate the effect of the LNG-IUS and TCU 380A users on the sub-endometrial vascularization and the uterine artery blood flow using power Doppler analysis and ultrasonography pulsed color Doppler during the precise mid-luteal phase.


Condition Intervention
Healthy
 Device: intra-uterine device (TCu 380A)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: The Effect of the Levonorgestrel-Releasing Intrauterine System and the Copper-Intrauterine Device (TCu 380A) on Subendometrial Microvascularization and Uterine Artery Blood Flow.

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Ultra-sound doppler, IP and IR indexes [ Time Frame: 3 mo ]

Secondary Outcome Measures:
  • pelvic pain, uterine bleediing [ Time Frame: 3 mo ]

Enrollment: 63
Study Start Date: January 2004
Study Completion Date: November 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Regularly menstruating women (menstrual cycle varying between 24-35 days);
  • Normal serum TSH, FSH and prolactin levels (as measured on day-3) and with less than 40 years. Contraceptive pills or any kind of hormonal medication had not been taken for (at least) 3 months prior to the study and any intrauterine device had necessarily been removed at least 3 months earlier. Patients were allowed to not use non-steroidal anti-inflammatory drugs (NSAID) within 24 h prior to any examination.

Exclusion Criteria:

  • Pregnancy, acute or chronic pelvic inflammatory disease, menorrhagia for unknown reason, copper allergy, cervicitis, dysplasia in the cervix or genital tumor. All patients underwent a gynecological examination and had a Papanicolaou smear taken during the previous 12 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489463

Locations
Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, RGS, Brazil, 90003051
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
UFRGS
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
Principal Investigator: Joao Cunha-Filho, PhD Professor UFRGS
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00489463     History of Changes
Other Study ID Numbers: IUD vascularization
Study First Received: June 19, 2007
Last Updated: June 20, 2007
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:
LNG-IUS
TCu 380A
Ultrasonography
Doppler color
 power Doppler
female
Volunteers

ClinicalTrials.gov processed this record on May 23, 2013