Comparative Study of the VeraCept Low-Dose Intrauterine Copper Contraceptive vs. the TCu380 Copper IUD
NCT ID: NCT02167763
Last Updated: 2022-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
300 participants
INTERVENTIONAL
2013-11-30
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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VeraCept Intrauterine Contraceptive
The VeraCept low-dose Intrauterine Copper Contraceptive
VeraCept Intrauterine Copper Contraceptive
TCu380
A commercial standard T-shaped copper IUD (TCu380)
TCu380 IUD
Interventions
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VeraCept Intrauterine Copper Contraceptive
TCu380 IUD
Eligibility Criteria
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Inclusion Criteria
* Have had at least one child (parous) and currently seeking long acting reversible contraception
* Normal uterine cavity as determined by ultrasound
* Willing to sign informed consent
* Able and willing to comply with study assessment schedule
Exclusion Criteria
* Pregnant (at time of enrollment)
* Known anatomical abnormalities of uterus, cervix and/or fallopian tubes
* Diagnosed or in treatment for cancer
* Untreated acute cervicitis
* In treatment for active Pelvic Inflammatory Disease
* Unexplained uterine bleeding or menometrorrhagia
* Known allergy to copper (Wilson's Disease) or imaging contrast media
* Unsuitable for study participation in the opinion of the Principal Investigator
18 Years
42 Years
FEMALE
Yes
Sponsors
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Sebela Women's Health Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Juan M. Canela, M.D.
Role: PRINCIPAL_INVESTIGATOR
Clinica Canela
Locations
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Clinica Canela
La Romana, , Dominican Republic
Countries
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Other Identifiers
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CM2010.01
Identifier Type: -
Identifier Source: org_study_id
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