New IUDs may expand contraceptive choices
New IUDs may expand contraceptive choices
Where does intrauterine contraception fit in the array of family planning choices you offer your patients? If you never or rarely perform intrauterine device (IUD) insertions, new devices now under development may lead you to give the method a second look.
The Belgian research organization Contrel is testing a T-shaped levonorgestrel-releasing intrauterine system (IUS), which it has trademarked as Femilis, with a smaller version for nulliparous women trademarked as Femilis Slim. Both devices release a daily dose of 20 mcg levonorgestrel, similar to the currently available Mirena IUS (Berlex, Montville, NJ.) Femilis is in clinical development for the treatment of menorrhagia, for endometrial suppression during estrogen replacement therapy, and for contraception, states Dirk Wildemeersch, MD, founder of Contrel.
T-shaped IUDs have been used for several decades. Health care providers are familiar with their insertion, and fitting requires minimal training, he reports. The combination of drug delivery technology with a conventional IUD frame is therefore attractive for use by such nonspecialist providers as nurses, midwives, and general practitioners, as well as those who are not inserting IUDs on a regular basis, he states. Femilis is especially designed for this target group of health care provider, says Wildemeersch. While Femilis utilizes a push-in technique, Mirena is released into the uterus by pulling back a "slider" mechanism.
"To minimize problems at insertion, an easy and safe push-in technique has been developed," he states. "The simplicity of this technique may make the method more accessible to women in remote places."
Review the research
Research has just been published on the ease of insertion, contraceptive efficacy, and safety of the two Femilis designs, as well as an analysis of the impact of the Femilis IUS on menstrual blood loss in women with and without menorrhagia.1,2
In the first study, 142 parous women were fitted with the Femilis device, with 92 women receiving the Femilis Slim device. The devices were inserted using the simplified push-in technique. Insertion was reported as "easy" in 97.9% of all women; pain at insertion was absent in 24.7% of study participants and described as "mild" in 67.7% of women.1
At the time of study analysis, 76 women had the Femilis IUS in place for periods in excess of one year. No pregnancies had been observed, investigators report. There was one expulsion in the nulliparous group and one in the parous group. Ten removals, mainly for bleeding and pain, were performed for medical reasons. One pelvic infection, caused by Chlamydia trachomatis, occurred in a nulliparous woman. The infection was resolved without removing the IUS. No other serious adverse events were reported.1
In the second published study, 60 women used the Femilis IUS for four to more than 30 months, with investigators analyzing menstrual blood use using the visual assessment technique. Twenty-eight women had normal menstrual periods at baseline, and 32 women had idiopathic menorrhagia.
Study findings indicate that menstrual blood loss scores dropped significantly during the observation period in almost all the study participants. The median menstrual score at baseline in women with normal menstrual bleeding was 140 (range 80-160) and dropped to a median score of 5 (range 0-150) at follow-up, resulting in a decrease of 96%.
In the 32 women with menorrhagic bleeding at baseline, menstrual flow dropped from a median score of 232 (range 185-450) at baseline to a median score of 3 (range 0-50) at follow-up, which is a decrease of 99%. Twenty women developed amenorrhea (33%), which was distributed equally among the normal/menorrhagic groups.2
The impact on menstrual blood loss of the Femilis system confirms other studies with devices releasing the same or lower amounts of levonorgestrel.3 The device’s impact in suppressing the endometrium could offer a health benefit and improvement in quality of life, particularly in women with heavy bleeding and anemia, the researchers conclude.2
Contrel also has developed the GyneFix, a frameless IUD, which is available in Europe and China. The device’s design consists of several copper cylinders tied together on a string and is anchored 1 cm deep into the top of the uterus.4 Its design is intended to cause less pain and bleeding than framed devices.5 It is not yet available in the United States. It could be marketed in the U.S. in cooperation with a suitable partner, says Wildemeersch.
The company also is developing FibroPlant-LNG, a levonorgestrel-releasing IUS. Based on the same design as the GyneFix IUD, it delivers a daily dose of 14 mcg levonorgestrel. Initial studies indicate that the device may be highly acceptable and be effective in reducing bleeding.6,7
"A greater variety of intrauterine systems will encourage use by women who have been denied this safe and effective method: younger women and those who have not had children," says Philip Darney, MD, MSc, professor of obstetrics and gynecology at University of California, San Francisco, and chief of obstetrics, gynecology, and reproductive sciences at San Francisco General Hospital. "These new systems will also treat conditions like abnormal uterine bleeding, uterine myomata, and endometriosis, making risky surgery less common just as current intrauterine contraceptives have made sterilization operations less frequent."
References
- Wildemeersch D, Janssens D, Vrijens M, et al. Ease of insertion, contraceptive efficacy and safety of new T-shaped levonorgestrel-releasing intrauterine systems. Contraception 2005; 71:465-469.
- Wildemeersch D, Rowe PJ. Assessment of menstrual blood loss in Belgian users of a new T-shaped levonorgestrel-releasing intrauterine system. Contraception 2005; 71:470-473.
- Hurskainen R, Paavonen J. Levonorgestrel-releasing intrauterine system in the treatment of heavy menstrual bleeding. Curr Opin Obstet Gynecol 2004; 16:487-490.
- Upadhyay, UD. New contraceptive choices. Population Reports, Series M, No. 19. Baltimore, The Johns Hopkins Bloom-berg School of Public Health, The INFO Project, April 2005.
- Masters T, Everett S. Intrauterine and barrier contraception (a practical review of recent developments). Current Obstetrics and Gynaecology 2005; 15:31-37.
- Wildemeersch D, Schacht E, Wildemeersch P. Contraception and treatment in the perimenopause with a novel "frameless" intrauterine levonorgestrel-releasing drug delivery system: An extended pilot study. Contraception 2002; 66:93-99.
- Wildemeersch D. Schacht E, Wildemeersch P, et al. Development of a miniature, low-dose, frameless intrauterine levonorgestrel-releasing system for contraception and treatment: A review of initial clinical experience. Reproductive Biomedicine Online 2002; 4:71-82.
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