Prevention of PregnancyPhase 1NCT02167763
Comparative Study of the VeraCept Low-Dose Intrauterine Copper Contraceptive vs. the TCu380 Copper IUD
A Phase 1 study testing VeraCept Intrauterine Copper Contraceptive and TCu380 IUD in people with Prevention of Pregnancy, run by Sebela Women's Health Inc. at 1 site in Dominican Republic.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prevention of Pregnancy
- What is being tested?
- VeraCept Intrauterine Copper Contraceptive and TCu380 IUD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteDominican Republic
- Study dates
- Nov 2013to 31 Dec 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the VeraCept Intrauterine Device for Long Acting Reversible Contraception
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
- Prevention of Pregnancy
- Being tested
- VeraCept Intrauterine Copper Contraceptive, TCu380 IUD
- Keywords
- contraception, IUD, copper
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VeraCept Intrauterine Copper ContraceptiveDevice
TCu380 IUDDevice
| Study group | Role | What they receive |
|---|---|---|
| VeraCept Intrauterine Contraceptive | Experimental | The VeraCept low-dose Intrauterine Copper Contraceptive Receives: Device: VeraCept Intrauterine Copper Contraceptive |
| TCu380 | Active comparator | A commercial standard T-shaped copper IUD (TCu380) Receives: Device: TCu380 IUD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contraceptive Effectiveness
Number of subjects who become pregnant during the study period
Measured: 12 Months
Placement Feasibility
Ability of the clinician to successfully place the device
Measured: At Enrollment
Secondary outcomes (3)
Device Expulsion
Number of subjects identified with partially or fully expelled devices
Measured: 12 Months
Tolerability
Number of subjects who request device removal due to inability to tolerate the intervention (device)
Measured: 12 Months
Pain at Insertion
Subject reported pain scores at device insertion
Measured: At Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study startNov 2013
- Primary completionDec 2014
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sebela Women's Health Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juan M. Canela, M.D., Principal investigator, Clinica Canela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167763
- Sponsor's protocol ID
- CM2010.01
- Status last verified
- Apr 2022
- First submitted
- 17 Jun 2014
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the VeraCept Intrauterine Device for Long Acting Reversible Contraception
- ClinicalTrials.gov ID
- NCT02167763
- Acronym / sponsor ID
- CM2010.01
- Conditions
- Prevention of Pregnancy
- Keywords
- contraception, IUD, copper
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sebela Women's Health Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 19 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VeraCept Intrauterine Contraceptive | Experimental | Device: VeraCept Intrauterine Copper ContraceptiveThe VeraCept low-dose Intrauterine Copper Contraceptive |
| TCu380 | Active comparator | Device: TCu380 IUDA commercial standard T-shaped copper IUD (TCu380) |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VeraCept Intrauterine Copper Contraceptive | Device | VeraCept Intrauterine Contraceptive |
| TCu380 IUD | Device | TCu380 |
Primary outcome
Contraceptive Effectiveness
Time frame: 12 Months
Number of subjects who become pregnant during the study period
Placement Feasibility
Time frame: At Enrollment
Ability of the clinician to successfully place the device
3 secondary outcomes
Device Expulsion
Time frame: 12 Months
Tolerability
Time frame: 12 Months
Pain at Insertion
Time frame: At Enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
Related trials for Prevention of Pregnancy
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
RecruitingObservational study
Urinary Biomarker-Based Diagnostic and Monitoring System for Chronic Kidney Disease and Real-World Effectiveness of SGLT2 Inhibitors
Chronic Kidney Disease
Recruiting
Use Misoprostol to Optimize Prevention of Cervical Cancer
Cervical Cancers
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan M. Canela, M.D. principal investigator
Clinica Canela
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VeraCept Intrauterine Copper Contraceptive and TCu380 IUD in people with Prevention of Pregnancy, run by Sebela Women's Health Inc. at 1 site in Dominican Republic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contraceptive Effectiveness (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.