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

Sebela Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Prevention of Pregnancy

Treatments: Device: VeraCept Intrauterine Copper Contraceptive; Device: TCu380 IUD

Study type: Interventional

Funder types: Industry

Identifiers

NCT02167763

CM2010.01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

VeraCept Intrauterine Contraceptive

Experimental group

Description:

The VeraCept low-dose Intrauterine Copper Contraceptive

Treatment:

Device: VeraCept Intrauterine Copper Contraceptive

TCu380

Active Comparator group

Description:

A commercial standard T-shaped copper IUD (TCu380)

Treatment:

Device: TCu380 IUD