NCT00489463

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable healthy

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2007

Completed
Last Updated

June 21, 2007

Status Verified

January 1, 2006

First QC Date

June 19, 2007

Last Update Submit

June 20, 2007

Conditions

Healthy

Keywords

LNG-IUSTCu 380AUltrasonographyDoppler colorpower DopplerfemaleVolunteers

Outcome Measures

Primary Outcomes (1)

  • Ultra-sound doppler, IP and IR indexes

    3 mo

Secondary Outcomes (1)

  • pelvic pain, uterine bleediing

    3 mo

Interventions

intra-uterine device (TCu 380A)DEVICE

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, RGS, 90003051, Brazil

Location

MeSH Terms

Interventions

Intrauterine Devices

Intervention Hierarchy (Ancestors)

Contraceptive Devices, FemaleContraceptive DevicesEquipment and Supplies

Study Officials

  • Joao Cunha-Filho, PhD

    Professor UFRGS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 19, 2007

First Posted

June 21, 2007

Study Start

January 1, 2004

Study Completion

November 1, 2006

Last Updated

June 21, 2007

Record last verified: 2006-01

Locations

BR(1)