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

Prevention of Pregnancy Clinical Trial

Official title:

Study of the VeraCept Intrauterine Device for Long Acting Reversible Contraception

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02167763
• Other study ID #: CM2010.01
• Status: Completed
• Phase: Phase 1
• Start date: November 2013
• Est. completion date: December 31, 2017

Study information

• Verified date: April 2022
• Source: Sebela Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 31, 2017
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Prevention of Pregnancy

Intervention

Device:
• VeraCept Intrauterine Copper Contraceptive

• TCu380 IUD

Locations

Country	Name	City	State
Dominican Republic	Clinica Canela	La Romana

Sponsors (1)

Lead Sponsor	Collaborator
Sebela Women's Health Inc.

Country where clinical trial is conducted

Dominican Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contraceptive Effectiveness	Number of subjects who become pregnant during the study period	12 Months
Primary	Placement Feasibility	Ability of the clinician to successfully place the device	At Enrollment
Secondary	Device Expulsion	Number of subjects identified with partially or fully expelled devices	12 Months
Secondary	Tolerability	Number of subjects who request device removal due to inability to tolerate the intervention (device)	12 Months
Secondary	Pain at Insertion	Subject reported pain scores at device insertion	At Enrollment