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IUD Uterine Vascularization and Side Effects

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ClinicalTrials.gov Identifier: NCT00489463
Recruitment Status : Completed
First Posted : June 21, 2007
Last Update Posted : June 21, 2007
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Healthy Device: intra-uterine device (TCu 380A)

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single
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.
Study Start Date : January 2004
Study Completion Date : November 2006
Arms and Interventions

Outcome Measures

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

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

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00489463

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

ClinicalTrials.gov Identifier: NCT00489463     History of Changes
Other Study ID Numbers: IUD vascularization
First Posted: June 21, 2007    Key Record Dates
Last Update Posted: June 21, 2007
Last Verified: January 2006

Keywords provided by Hospital de Clinicas de Porto Alegre:
TCu 380A
Doppler color
power Doppler