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

• Sponsor: Sebela Women's Health Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02167763
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 2
• Duration (Months): 50
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prevention of Pregnancy	Device: VeraCept Intrauterine Copper Contraceptive; Device: TCu380 IUD	Phase 1

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

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Study of the VeraCept Intrauterine Device for Long Acting Reversible Contraception
• Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Contraceptive Effectiveness [12 Months]

   Number of subjects who become pregnant during the study period

2. Placement Feasibility [At Enrollment]

   Ability of the clinician to successfully place the device

Secondary Outcome Measures

1. Device Expulsion [12 Months]

   Number of subjects identified with partially or fully expelled devices

2. Tolerability [12 Months]

   Number of subjects who request device removal due to inability to tolerate the intervention (device)

3. Pain at Insertion [At Enrollment]

   Subject reported pain scores at device insertion

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 42 Years
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinica Canela	La Romana		Dominican Republic

Sponsors and Collaborators

• Sebela Women's Health Inc.

Investigators

• Principal Investigator: Juan M. Canela, M.D., Clinica Canela

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sebela Women's Health Inc.
• ClinicalTrials.gov Identifier: NCT02167763
• Other Study ID Numbers: CM2010.01
• First Posted: Jun 19, 2014
• Last Update Posted: Apr 12, 2022
• Last Verified: Apr 1, 2022

• Keywords provided by Sebela Women's Health Inc.: contraception; IUD; copper
• Additional relevant MeSH terms: Copper; Contraceptive Agents

Study Results

No Results Posted as of Apr 12, 2022