Evaluation of ContraMed VeraCept Intrauterine Copper Contraceptive for Long Acting Reversible Contraception

Contraception Clinical Trial

Official title: Evaluation of the Effectiveness, Safety and Tolerability of the ContraMed VeraCept Intrauterine Copper Contraceptive for Long-Acting Reversible Contraception

Status Completed

Clinical Trial Summary

Prospective, multi-center, single-arm, open-label, Phase II clinical study to evaluate the effectiveness, device placement, safety, and tolerability of VeraCept to support commencing a Phase III Clinical Study

Clinical Trial Description

Up to 250 subjects will be consented, screened and have VeraCept placed, with a goal to have 2240 evaluable cycles at 12 months. It is planned that 225 of the 250 subjects will be within the 18-35 year age range, with a total of 2015 evaluable cycles. The remaining 25 subjects will be within the 35-40 year age range.

Follow-up: Physical assessment (office visit) will occur at weeks 6, 13, 26 and 52 after placement, with monthly telephone contact. For those subjects who wish to continue study device use after 12 months, follow-up office visits will occur every 6 months. Additional visits will be conducted if necessary for safety issues.

Follow-up after early study device removal:

Subjects requesting VeraCept removal to become pregnant will be followed to pregnancy or until the subject changes their mind about trying to get pregnant. All subjects in whom VeraCept is removed prior to 12 months, for any reason, will be required to use an alternative contraceptive for the first two weeks following removal. Progestin-only pills will be provided by the sponsor as a contraceptive option during this time unless the subject has a category 4 condition precluding their use.

Study Population: Pre-menopausal women ages 18 - 40, at risk for pregnancy, who are interested in using an intrauterine contraceptive for birth control will be eligible for this study. Subjects must provide written informed consent and meet the study subject selection criteria without any exclusions as outlined in the Clinical Investigation Plan (CIP).

Primary Effectiveness Outcome: The primary outcome measure is effectiveness, evaluated as the absence of pregnancy by 12 months, failure will be calculated by the Pearl Index.

Safety and Other Outcome

Measures: Safety and other outcome measures include:

Study Device Placement:

• Ease of placement

• Placement success

Safety:

• Serious Adverse Events

• Adverse Events

Tolerability:

• Bleeding and spotting patterns

• Discontinuation rate and reasons for discontinuation ;

Related Conditions & MeSH terms

• Contraception

• NCT number: NCT02446821
• Study type: Interventional
• Source: Sebela Pharmaceuticals Inc.
• Status: Completed
• Phase: Phase 2
• Start date: June 2015
• Completion date: March 22, 2019