ContraMed is on the move:
- – ContraMed Completes Enrollment in U.S. Phase 2 Study for LevoCept
ContraMed today announced that it has completed enrollment in its U.S. Phase 2 Clinical Study of LevoCept, a levonorgestrel-based long acting reversible contraceptive device. Over 275 subjects were enrolled at over 14 centers across the U.S. The LevoCept Phase 2 Study is a multicenter study designed to evaluate the safety and effectiveness of LevoCept in a population of parous and nulliparous women seeking long acting, reversible contraception.
- – VeraCept U.S. Phase 2 Study Achieves Primary Endpoints
ContraMed today announced that its U.S. Phase 2 Study of VeraCept, a ground-breaking new hormone-free IUD, had achieved its primary study endpoints as defined in the study protocol. Primary efficacy and safety endpoints at 1 year, as well as secondary endpoints at 1 year were all achieved. Longer term study follow up has been initiated, with subjects allowed to continue for up to 3 years of use. VeraCept is a low-dose copper IUD currently undergoing clinical evaluation in the U.S.
- – Publication of VeraCept Randomized Clinical Study Results
ContraMed today announced the publication of the results of a prospective, randomized clinical evaluation of VeraCept compared to a standard copper IUD. The paper, “A randomized comparison of a novel nitinol fame low-dose copper intrauterine contraceptive and a copper T380S intrauterine contraceptive” reports primary and secondary comparative outcomes over 24 months of use.
Published online at the journal Contraception.
- – ContraMed Begins Second U.S. Phase 2 Clinical Study
ContraMed is pleased to announce the first enrollments in our latest U.S. Phase 2 Clinical Study, this one for the LevoCept Intrauterine Contraceptive. LevoCept is the second entry in the ContraMed portfolio of advanced intrauterine devices for long acting reversible contraception. LevoCept, a new generation of hormonal IUD, joins the VeraCept hormone-free IUD in clinical evaluation at a dozen clinical centers across the U.S. A total of six subjects were enrolled at the first two centers of the multi-center study designed to evaluate the safety and effectiveness of LevoCept in a population of parous and nulliparous women. The VeraCept U.S. Phase 2 study is ongoing and rapidly approaching its primary study endpoints. ContraMed is the only Women’s Health company developing an integrated portfolio of both hormone-free and hormonal intrauterine devices. Caution: VeraCept and LevoCept are not approved for commercial use, and are limited by Federal law to investigational use only.
- – ContraMed Announces the Addition of David Thompson as Vice President, Operations
ContraMed today announced the addition of medical device veteran Dave Thompson to the senior management team. Dave takes on the newly created position of Vice President, Operations bringing more than 20 years of device development and manufacturing experience to the organization. Dave was most recently Vice President, Manufacturing at PneumRx, an implantable device company with bronchial applications that was acquired by BTG International in late 2014.
- – ContraMed Completes Enrollment in U.S. Phase 2 Clinical Study for VeraCept
ContraMed today announced that it has completed enrollment in its groundbreaking U.S. Phase 2 Clinical Study of the VeraCept Low Dose Copper Contraceptive. Over 250 subjects have been enrolled at 12 centers across the U.S. The VeraCept Phase 2 Study is a multicenter study designed to evaluate the safety and effectiveness of VeraCept in a population of parous and nulliparous women seeking long acting, reversible contraception.
- – ContraMed Begins U.S. Phase 2 Clinical Study Enrollment
ContraMed announces its first enrollments in its U.S. Phase 2 Clinical Study of the VeraCept Low Dose Copper Contraceptive. A total of five (5) subjects were enrolled at the first two centers of its ten center study designed to evaluate the safety and effectiveness of VeraCept in a study population of parous and nulliparous women seeking long acting, reversible contraception.
- – ContraMed Receives Upgraded Quality Systems Certification
ContraMed receives its upgraded Quality Systems Certification in accordance with ISO 13485:2003 covering the Design, Development, Production and Sterilization of Long Acting Reversible Contraceptive products for Women. The company intends to proceed with the activities necessary for the submission of a CE Mark application for VeraCept, its low-dose Intrauterine Copper Contraceptive for parous and nulliparous women.
- – ContraMed Presents at ACOG
ContraMed highlights the successful presentation at the American College of Obstetrics and Gynecology (ACOG), San Francisco, CA, of the company’s initial clinical evaluation of the VeraCept Low Dose Copper Contraceptive. The study, “A Randomized Single-Blinded Trial of VeraCept, a Novel Low-dose Copper Intrauterine Contraceptive compared to the Copper T380”, was presented by Matthew Reeves, M.D, on behalf the clinical investigation team.
- – VeraCept Phase 2 Clinical Study Receives Clearance
ContraMed receives clearance for the initiation of its ground-breaking Phase 2 Clinical Study of the VeraCept Low Dose Copper Contraceptive.