The objective of this open randomized study was to compare the clinical performance of Nova T��380 and Gyne T��380 Slimline copper intrauterine devices (IUDs).
Materials and Methods
Eligible for analyses were 957 Norwegian parous women aged 18���45 years. Clinical performance was measured upon the removal of IUD due to contraceptive failure, expulsion, bleeding, pain, pelvic inflammatory disease and other medical reasons during a 5-year study period.
The discontinuation rate due to contraceptive failure was significantly higher in the first year for Nova T��380 users than for Gyne T��380 Slimline users, whereas no differences were observed thereafter (the 5-year cumulative failure rates were 4.4% and 2.2%, respectively, per 100 women). However, the partial expulsion rate was significantly higher in the first year for Gyne T��380 Slimline users than for Nova T��380 users (the 5-year cumulative rates were 3.4% and 1.1,% respectively, per 100 women). No other major differences in reasons for discontinuation were found between the study groups. There was a slight nonsignificant increase in hemoglobin levels for both study groups over the course of the study.
Clinical performance was considered satisfactorily high for both devices.
To read this article in full you will need to make a payment
Purchase one-time access:Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
One-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:Subscribe to Contraception
Already a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
- IUDs ��� an update. Population reports (B6).Johns Hopkins School of Public Health, Population Information Program, Baltimore (Md)1995
- Hormonally impregnated intrauterine systems (IUSs) versus other forms of reversible contraceptives as effective methods of preventing pregnancy.Cochrane Database Syst Rev. 2004; 3 ([art. no. CD001776])https://doi.org/10.1002/14651858.CD001776.pub2
- Medical eligibility criteria for contraceptive use.3rd ed. World Health Organization, Geneva2004
- Selected practice recommendations for contraceptive use.2nd ed. World Health Organization, Geneva2004
- A plethora of IUDs: but how safe, how effective?.Prog Reprod Health Res. 2002; 60: 3
- Choice of contraceptive modality by women in Norway.Acta Obstet Gynecol Scand. 1994; 73: 48-52
- US women's perceptions of and attitudes about the IUD.Obstet Gynecol Surv. 1996; 51: 30-34
- Perpetuating negative attitudes about the intrauterine device: textbooks lag behind the evidence.Contraception. 2002; 65: 389-395
- Intrauterine devices.Best Pract Res Clin Obstet Gynaecol. 2002; 16: 155-168
- The intrauterine device today.J SOGC. 1993; 15: 921-924
- The GyneFix implant systems for interval, postabortal and postpartum contraception: a significant advance in long-term reversible contraception. International Study Group on Intrauterine Drug Delivery.Eur J Contracept Reprod Health Care. 1997; 2: 1-13
- Intrauterine device and upper-genital-tract infection.Lancet. 2000; 356: 1013-1019
- Four-year experience in a randomized study of the Gyne T 380 Slimline and the standard Gyne T 380 intrauterine copper device.Contraception. 1993; 47: 37-42
- Five-year clinical experience with Nova T380 copper IUD.Contraception. 2002; 66: 309-314
- Clinical performance of the Nova T380 intrauterine device in routine use by the UK Family Planning and Reproductive Health Research Network: 5-year report.J Fam Plann Reprod Health Care. 2002; 28: 69-72
- Random allocation of patients to different treatments.in: Guide to MEDSTAT, version 2.12. Statistical program for the analysis of the results of controlled therapeutic trials and other types of clinical research. Department of Medical Gastroenterology C, Herlev University Hospital, Copenhagen1988
- IUD users in Norway are at low risk for genital C. trachomatis infection.Contraception. 1996; 54: 209-212
- Clinical performance of the Nova-T380 IUD in routine use by the UK Family Planning and Reproductive Health Research Network: 12-month report.Br J Fam Plann. 2000; 26: 148-151
- Research on intrauterine devices.in: UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction. Annual technical report 1995, Part 1. World Health Organization, Geneva1996: 137-148
- Dose- and age-dependent ectopic pregnancy risks with intrauterine contraception.Obstet Gynecol. 1991; 78: 291-298
Published online: October 30, 2006
Accepted: September 7, 2006
Received in revised form: September 5, 2006
Received: July 3, 2006
���This study has been financially supported by Schering Oy (formerly Leiras Oy).
© 2007 Elsevier Inc. Published by Elsevier Inc. All rights reserved.