CompletedNCT02167763Updated Apr 12, 2022

Comparative Study of the VeraCept Low-Dose Intrauterine Copper Contraceptive vs. the TCu380 Copper IUD

A Phase 1 interventional study of VeraCept Intrauterine Copper Contraceptive and TCu380 IUD in Prevention of Pregnancy, sponsored by Sebela Women's Health Inc.. Completed at 1 site in Dominican Republic. Open to female participants aged 18 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-12.

Sponsored by Sebela Women's Health Inc. · Phase 1, Interventional, and Prevention

Phase: Phase 1
Study type: Interventional
Enrollment: 300
Allocation: Randomized
Ages: 18 Years to 42 Years
Sex: Female

Study summary

The purpose of this study is to evaluate the safety and effectiveness of the VeraCept Low Dose Intrauterine Copper Contraceptive compared to the standard T shaped copper IUD, the TCu380.

Read the detailed description

This is a prospective, randomized, subject-blinded, two arm controlled study of the Safety, Feasibility and Effectiveness of the VeraCept low-dose intrauterine copper contraceptive as compared to a concurrently controlled, commercially available standard copper "T" IUD (TCu380).

Conditions studied

Prevention of Pregnancy

Keywords

contraception
IUD
copper

In context

Lead sponsor

Sebela Women's Health Inc. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 42 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

Inclusion criteria

Adult females ages 18 to 42 (pre-menopausal)
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

Exclusion Criteria:

Post menopausal
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

Study design

Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 300 participants (estimated)

Study arms

Experimental
VeraCept Intrauterine Contraceptive
The VeraCept low-dose Intrauterine Copper Contraceptive
Device: VeraCept Intrauterine Copper Contraceptive
Active comparator
TCu380
A commercial standard T-shaped copper IUD (TCu380)
Device: TCu380 IUD

Interventions

DeviceVeraCept Intrauterine Copper Contraceptive
DeviceTCu380 IUD

What researchers measure

Primary outcomes

Contraceptive Effectiveness
Number of subjects who become pregnant during the study period
Time frame: 12 Months
Placement Feasibility
Ability of the clinician to successfully place the device
Time frame: At Enrollment

Secondary outcomes

Device Expulsion
Number of subjects identified with partially or fully expelled devices
Time frame: 12 Months
Tolerability
Number of subjects who request device removal due to inability to tolerate the intervention (device)
Time frame: 12 Months
Pain at Insertion
Subject reported pain scores at device insertion
Time frame: At Enrollment

Study locations

1 site

Clinica Canela
La Romana, Dominican Republic

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02167763
Lead sponsor: Sebela Women's Health Inc.
Responsible party: Sponsor
First posted: Jun 19, 2014
Start date: Nov 2013
Primary completion: Dec 2014
Completion: Dec 31, 2017
Last update: Apr 12, 2022

Study contacts

Juan M. Canela, M.D.

principal investigator · Clinica Canela

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Sebela Women's Health Inc.

Start the discussion