Si está buscando comprar medicamentos en línea en España, es importante elegir una farmacia en línea de confianza y segura para garantizar que los medicamentos que reciba sean auténticos y de alta calidad. En comprar-farmacia.es, ofrecemos una amplia selección de medicamentos, incluido Cialis para la disfunción eréctil (DE), y trabajamos con farmacias acreditadas para garantizar la calidad y la autenticidad de nuestros productos.
Visite nuestro sitio web en comprar-farmacia.es para obtener más información sobre nuestros productos y servicios. Nuestro equipo de atención al cliente está disponible para ayudarlo en todo momento y garantizar una experiencia de compra en línea segura y satisfactoria.
Doi:10.1016/j.contraception.2004.02.006
Assessment of menstrual blood loss in Belgian users of the frameless
copper-releasing IUD with copper surface area of 200 mm2 and users
of a copper-levonorgestrel-releasing intrauterine system
bReproductive Health Consultant, Vesancy, France
Received 5 January 2003; received in revised form 3 February 2004; accepted 16 February 2004
Abstract Objective: This study was conducted to evaluate the effect of a miniaturized frameless copper IUD (GyneFix 200 small) and a copper-levonorgestrel (GynePlant™) intrauterine system (IUS) on the amount of menstrual blood loss (MBL). Methods: In 60 Belgian women using GyneFix 200 and 21 using GynePlant, MBL was assessed with the visual assessment technique. Results: MBL scores in GyneFix 200 users did not change from baseline during the mean observation period of 31 months. In GynePlant users, mean MBL scores decreased by at least 50% in all but one user. Conclusion: The impact of copper IUDs on MBL can be minimized by reducing the surface area of the foreign body. Reduction of MBL, without causing amenorrhea, can be obtained by adding levonorgestrel. 2004 Elsevier Inc. All rights reserved. Keywords: GyneFix copper contraceptive; Anchored IUS; Frameless IUD; GynePlant
1. Introduction
IUD As the increase in MBL in IUD users is propor-tional to the size of the IUD, it seemed logical to experiment
The standard GyneFix with effective copper surface
with copper IUD models that have no plastic frame to limit
area of 330 mm2 is a highly effective intrauterine contra-
the size of the foreign body. The present study reports on the
ceptive device (IUD). Cumulative failure rates range from
MBL observed during use of the small GyneFix 200 IUD,
0.0/100 users to 2.5/100 users up to 10 years of use (data
compared with before use. Previous studies demonstrated
from published and unpublished randomized and nonran-
the high efficacy of the small frameless IUD in a 3-year
domized comparative clinical trials) The high efficacy
of the GyneFix IUD is attributed to the fact that the frame-
Furthermore, the knowledge that intrauterine progestin-
less device is anchored to the fundus of the uterus, elimi-
release drastically reduces MBL prompted the authors to
nating downward displacement, which increases the failure
assess the effect of a combined copper-levonorgestrel-re-
rate, and because the total surface area of the copper sleeves
(inner and outer surfaces) is available for release of copperions.
An important drawback of IUDs is their tendency to
2. Materials and methods
cause heavy, sometimes painful, menstrual bleeding. Heavybleeding is the most common cause for IUD discontinua-
The use of the study products was approved by the
tion. The GyneFix standard also increases menstrual blood
loss (MBL), although to a lesser degree than the TCu380A
2.1. Description of the IUD and IUS
The two intrauterine devices are described briefly below
* Corresponding author, present affiliation. Piers de Raveschootlaan
(see They use the same anchoring system as de-
125, 8300 Knokke, Belgium. Tel.: ϩ32-50-600900; fax: ϩ32-50-622429. E-mail address: [email protected] (D. Wildemeersch).
0010-7824/04/$ – see front matter 2004 Elsevier Inc. All rights reserved. doi:10.1016/j.contraception.2004.02.006
D. Wildemeersch, P.J. Rowe / Contraception 70 (2004) 169 –172
Fig. 1. GyneFix 200 (small) (left), GynePlant™ (right).
The GyneFix 200 (small) IUD consists of four copper
sleeves only, with total length of 2 cm, and with total
The statistical significance in the studies using the visual
surface area of copper, including the inner and outer sur-
assessment technique was calculated according to the Wil-
coxon signed-rank test, p Ͻ 0.05 denoting significance.
The GynePlant IUS consists of the same number of
3. Results
copper sleeves as the GyneFix 200 IUD. Attached to thelower copper tube extends a fibrous delivery system of
1.2 mm in diameter and 1.5 cm in length deliveringapproximately 5 g of levonorgestrel (LNG) per day for
MBL was assessed in 60 Belgian parous (n ϭ 23) and
nulliparous women (n ϭ 37) using the visual assessmentscoring technique as described. The trial covers a periodfrom a minimum of 9 months to more than 3 years. Women
2.2. Assessment of MBL using the visual assessment
subjectively reported similar menstruation patterns with the
GyneFix 200 IUD when compared with MBL before inser-tion. This corresponds closely with the menstrual scores
Women with normal and with heavy menstrual periods
The median bleeding score before treatment was
were admitted in the study. A visual assessment tech-
110.5 (range, 28 –265) and 110 (range, 28 –260) after 3–51
nique was used as described by Janssen et al. Infor-
months follow-up, which is not statistically different (p ϭ
mation on menstrual bleeding was obtained by interview
prior to entering the study using a pictorial chart form todescribe the degree to which the sanitary wear wassoiled. A score was calculated by multiplying the numberof slightly, moderately and heavily soiled pads and tam-pons by 1, 5 and 20 for pads and 1, 5 and 10 for tampons,respectively, according to their degree of staining The visual assessment technique does not yield anexact flow in milliliters but, in practice, the sensitivityand specificity is reasonably high and superior to a wom-an’s subjective assessment of MBL. For purposes ofevaluating the effect of treatment, the visual assessmenttechnique is highly practical compared with the quanti-tative method as women no longer have to carry used
Fig. 2. The pictorial chart form. The numbers 1– 8 represent the consecu-
D. Wildemeersch, P.J. Rowe / Contraception 70 (2004) 169 –172
however, does not affect MBL. Milson et al. showed that
Characteristics of the study groupa and analysis of the visual menstrual
women using MLCu250 do not have reduced MBL compared
bleeding scores (MS) before and after use of the GyneFix® 200 IUD
to women wearing a high-load MLCu375 IUD Further
reduction of MBL can be achieved by adding a hormone-
releasing system. Levonorgestrel has been extensively studied
in this respect. The advantage of GynePlant is that the efficacy
of the device is not dependent on the LNG release as its 200
mm2 of copper surface area exposed to the uterine environ-
ment provides high contraceptive protection similar to the high
copper-load conventional IUDs, which have a much lower
Wilcoxon matched-pair signed-rank test: p ϭ 0.596 (NS).
proportion of exposed copper surface area
a N ϭ 60, parous n ϭ 23, nulliparous n ϭ 37.
A considerable reduction in MBL was seen in all but one
woman treated with the “low-dose” (5 g/d) GynePlant
copper-releasing IUS. The development of the framelessdevice is a response to the growing need to develop high-
MBL was assessed in 21 Belgian parous (n ϭ 7) and
performing, long-acting, reversible and acceptable contra-
nulliparous women (n ϭ 14) using the visual assessment
ceptives with a high continuation of use. The GynePlant is
scoring technique. The trial period ranged from 8 months to
a further development that may offer additional advantages,
more than 2 years. All women reported reduced bleeding
particularly with respect to reduced bleeding. This device
except one. In the latter, menstrual bleeding remained the
could be useful in women with heavy menstruation and who
same as before. No cases of amenorrhea (absence of men-
do not accept the amenorrhea associated in many cases with
strual bleeding during a period of 3 months) resulting from
the levonorgestrel intrauterine system. Another advantage
endometrial suppression were encountered The
of the GynePlant is that the contraceptive efficacy should be
mean bleeding score before treatment was 222.6 (range,
maintained after the drug reservoir is exhausted.
40 –530) and dropped to a mean score of 64.4 (range,5–150) after 8 –28 months follow-up, which is highly sta-tistically significant (p Ͻ 0.001). 5. Conclusion
The impact on MBL with copper IUDs can be minimized
4. Discussion
by reducing the surface area of the foreign body. Reduction ofMBL, without causing amenorrhea, can be obtained by adding
This article evaluated ways to minimize the effect on
levonorgestrel. The small frameless GyneFix IUD minimizes
MBL and to reduce the amount of menstrual bleeding with
the impact on MBL. It would appear likely that the contracep-
copper-releasing IUDs. Although the mechanism by which
tive efficacy of the GynePlant will even be enhanced due to the
this occurs is complex, the remedy seems to be simple. The
effect of the added potent contraceptive hormone.
present studies suggest that by significantly reducing thesurface area of the foreign body, the impact on the amountof menstrual bleeding will be minimized. A previous MBL
Acknowledgments
study found that the frameless copper-releasing IUD hasless impact on MBL than the larger TCu380A IUD The
The authors greatly acknowledge Prof. Dr. G. Van
frameless IUD may also reduce prolonged or intermenstrual
Maele, Dr. Sc., of the Department of Medical Informatics
bleeding due to the absence of a frame, eliminating the risk
and Statistics, University Hospital Ghent, Belgium, for pro-
of endometrial trauma. Reducing the copper surface area,
viding statistical data analysis for the study. Dirk Wilde-meersch is a Belgian gynecologist and Medical Director ofContrel Research, a company that was established to man-
age clinical research and to develop and study innovative
Visual menstrual bleeding scores (MS) before and during treatment
drug delivery technologies (www.contrel.be). Contrel is the
(observation from 8 months to 24 months) in 21 GynePlant™ users
manufacturer of GyneFix and GynePlant. References
[1] Wildemeersch D, Bata´r I, Affandi B, et al. The ‘frameless’ intrauterine
system for long-term, reversible contraception: a review of 15 years of
clinical experience. J Obstet Gynaecol Res 2003;290:160 –9.
Wilcoxon matched-pair signed-rank test: p Ͻ 0.001 (highly significant).
[2] Andrade ATL, Souza JP, Andrade GN, Rowe PJ, Wildemeersch D. D. Wildemeersch, P.J. Rowe / Contraception 70 (2004) 169 –172
Assessment of menstrual blood loss in Brazilian users of the frameless
[5] Janssen CA, Scholten PC, Heintz APM. A simple visual assessment
copper-releasing IUD with copper surface area of 330 mm2 and users
technique to discriminate between menorrhagia and normal menstrual
of the levonorgestrel-releasing intrauterine system. Contraception
blood loss. Obstet Gynecol 1995;85:977– 82.
[6] Milson I, Rybo G, Lindstedt G. The influence of copper surface area on
[3] Cao X, Zhang W, Zhao X, et al. Three-year efficacy and acceptability
menstrual blood loss and iron stores in women fitted with an IUD.
of the GyneFix® 200 intrauterine system (IUS). Contraception 2004;
[7] Wildemeersch D, Dhont M, Temmerman M, et al. GyneFix®-LNG:
[4] Wu S, Hu J, Wildemeersch D. Performance of the Frameless GyneFix
preliminary clinical experience with a copper and levonorgestrel re-
and the TCu380A IUDs in a three-year multicenter randomized com-
leasing intrauterine system. European J Contracept Reprod Health Care
parative trial in parous women. Contraception 2000;61:91–9.
XXIX CONVENCION DE UPADI 2004 DECLARACIÓN DE MEXICO En Ciudad de México, reunidos varios centenares de ingenieros de todas las latitudes delcontinente en la 29º Convención Panamericana de Ingenieros, convocada por UPADI, paraconcurrir a las reuniones de gobierno de la entidad y a 13 (trece) congresos panamericanos sobredistintos aspectos de la ingeniería (algunos congresos tan tradi
East Carolina Gastroenterology, PA Peter A. Eweje, MD 4, Office Park Drive Jacksonville, NC 28546, 910 353 6158 INSTRUCTIONS FOR MIRALAX PREP Your procedure is scheduled at our Endoscopy Center/OMH on You should expect to be at the endoscopy center for about 2 to 2 1/2 hours. Obtain your bowel prep products from your pharmacy and buy Gas-X from over-4 D