Silverlily and Goldlily IUDs: - The European Society of Contraception ...
Silverlily and Goldlily IUDs: - The European Society of Contraception ...
Silverlily and Goldlily IUDs: - The European Society of Contraception ...
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<strong>Silverlily</strong> <strong>and</strong> <strong>Goldlily</strong> <strong>IUDs</strong><br />
April 2006 IB * UDMHSC 7<br />
<strong>Silverlily</strong> <strong>and</strong> <strong>Goldlily</strong> <strong>IUDs</strong><br />
Clinical study characteristics 2.<br />
Patient characteristics<br />
Average age (years)<br />
Average # <strong>of</strong> birth (n)<br />
Average # <strong>of</strong> living children (n)<br />
Average # <strong>of</strong> ind. abortion (n)<br />
Average # <strong>of</strong> spont. abortion (n)<br />
Average # <strong>of</strong> ectopic pregn. (n)<br />
<strong>Silverlily</strong><br />
31.49<br />
2.05<br />
2.02<br />
0.94<br />
0.25<br />
0.02<br />
0.23<br />
0.01<br />
April 2006 IB * UDMHSC 9<br />
<strong>Silverlily</strong> <strong>and</strong> <strong>Goldlily</strong> <strong>IUDs</strong><br />
Terminations<br />
Pregnancy<br />
Expulsion<br />
Removal for<br />
bleeding/pain<br />
other medical reasons<br />
Competing risks, total<br />
<strong>Silverlily</strong><br />
1-12<br />
months<br />
LT rates<br />
0.7<br />
1.9<br />
6.1<br />
2.2<br />
13.7 *<br />
1-120<br />
months<br />
<strong>Goldlily</strong><br />
32.42<br />
1,96<br />
1.95<br />
0.84<br />
April 2006 IB * UDMHSC 11<br />
P.I.<br />
1,09<br />
1,33<br />
4,79<br />
2,41<br />
14,46<br />
<strong>Goldlily</strong><br />
1-12<br />
months<br />
LT rates<br />
0.7<br />
2.0<br />
5.3<br />
2.2<br />
11.8 *<br />
1-120<br />
months<br />
1,23<br />
1,52<br />
4,24<br />
2,06<br />
12,60<br />
LT rates calculated for 100 users P.I. = calculated for 100 users/one year<br />
* Chi-Square = 4.2673; Probability < 0.05<br />
P.I.<br />
<strong>Silverlily</strong> <strong>and</strong> <strong>Goldlily</strong> <strong>IUDs</strong><br />
Clinical study characteristics 1.<br />
Type <strong>of</strong> study<br />
• Human phase IV<br />
(post marketing)<br />
• Prospective<br />
• Non r<strong>and</strong>omized<br />
• Open label<br />
Statistical method<br />
• Life table<br />
- gross cumulative<br />
- first year <strong>of</strong> use<br />
• Pearl-index<br />
cumulative use (10 years)<br />
• c 2 calculation<br />
April 2006 IB * UDMHSC 8<br />
<strong>Silverlily</strong> <strong>and</strong> <strong>Goldlily</strong> <strong>IUDs</strong><br />
Clinical study characteristics 3.<br />
Characteristics<br />
Insertions (n)<br />
At risk (n), 1 st year<br />
10 th year<br />
CWMU (month)*, 1 st year<br />
10 th year<br />
<strong>Silverlily</strong><br />
3,290<br />
1,954<br />
63<br />
27,762<br />
102.725<br />
* CWMU = Cumulative Woman-month <strong>of</strong> Use<br />
<strong>Silverlily</strong> 1990-2005, <strong>Goldlily</strong> 1993-2005<br />
<strong>Goldlily</strong><br />
4,055<br />
2,253<br />
63<br />
32,628<br />
114.840<br />
April 2006 IB * UDMHSC 10<br />
<strong>Silverlily</strong> <strong>and</strong> <strong>Goldlily</strong> <strong>IUDs</strong><br />
Conclusions<br />
• Both devices provide good protection<br />
against unwanted pregnancy<br />
• Relevant termination rates are low<br />
• Continuation rates are high<br />
(first year figures: <strong>Silverlily</strong> 86.3%, <strong>Goldlily</strong> 88.2% )<br />
• Using alloy <strong>of</strong> Cu/Ag <strong>and</strong> Cu/Au provides a<br />
new possibility in intrauterine contraception<br />
(longer life span, less side effects )<br />
• Copper/noble metal alloys may create a new<br />
generation <strong>of</strong> <strong>IUDs</strong><br />
April 2006 IB * UDMHSC 12<br />
2
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