Alexander Teichmann, MD, PhD 1 1 Frauenklinik, Klinikum Aschaffenburg, Aschaffenburg, Germany

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Continuous LNG/EE, a Low-dose Continuous-use Oral Contraceptive, Provides Similar Efficacy and Safety to a Monthly Cyclic Oral Contraceptive. Alexander Teichmann, MD, PhD 1 1 Frauenklinik, Klinikum Aschaffenburg, Aschaffenburg, Germany. - PowerPoint PPT Presentation

Transcript of Alexander Teichmann, MD, PhD 1 1 Frauenklinik, Klinikum Aschaffenburg, Aschaffenburg, Germany

PowerPoint PresentationAlexander Teichmann, MD, PhD1
On behalf of:
2Gaubius Laboratory, TNO Quality of Life, Biomedical Research,
Leiden, The Netherlands; 3Research Headquarters, Wyeth Research, Collegeville, PA, USA; 4Wyeth Research, Paris, France.
Study funded by Wyeth Research, Collegeville, PA, USA.
*
Continuous levonorgestrel (LNG)/ethinyl estradiol (EE) is taken every day, 365 days a year, without a hormone-free interval
Elimination of the hormone-free interval may reduce the total number of bleeding days
Contains LNG (90 µg) and EE (20 µg) at the lowest combination of doses currently available in the United States
*
Secondary objective
To compare continuous LNG/EE to a similarly formulated 21/7 cyclic OC (LNG 100 µg/
*
Study Design
Phase III, randomized, open-label, 1-year study conducted at 44 sites in Europe
Czech Republic, Finland, Germany, Hungary, Italy, The Netherlands, Norway, Poland
Women were randomly assigned to take
*
Key Inclusion Criteria
Healthy women aged 18 to 49 years who were sexually active and willing to rely on a combination OC as their only means of contraception
*
per day
Use of any of the following within 60 days
of screening:
Hepatic enzyme-inducing drugs
*
Study Procedures
Women were instructed to begin taking the study drug on the first day of their menstrual bleeding
Women recorded vaginal bleeding and adverse events (AEs) on daily diary cards
Bleeding terms were defined according to the World Health Organization
Bleeding: required sanitary protection
Amenorrhea: no bleeding or spotting
A subset of women who met predetermined criteria were also screened for 4 metabolic panels
Included carbohydrate, fasting lipid, hemostasis, and bone maker panels
*
treatment group N = 651
No drug taken
n = 641
Completed continuous
LNG/EE arm
n = 216
P value
Contraceptive Efficacy
There were no on-treatment pregnancies among women in the continuous LNG/EE group
*
*
*
For continuous LNG/EE, the percentage
of women achieving amenorrhea generally increased with each pill pack to 53% at pill pack 13
The median number of bleeding/
spotting days decreased over time
for both study groups
0 for pill pack 2 to 13 for continuous LNG/EE
Median number of spotting days was 0 for pill packs
8 to 13 for continuous LNG/EE
*
Total treatment-emergent AEs
1 (0.3)
2 (0.6)
*
*
*
*
*Vaginal bleeding is a combination of COSTART terms metrorrhagia, menorrhagia,
and vaginal and uterine hemorrhage.
Vaginal bleeding*
Breast pain
Continuous LNG/EE
105 (32.5)
22 (6.8)
23 (7.1)
38 (11.9)
22 (6.9)
31 (9.7)
P value
Continuous LNG/EE
41 (15.8)
2 (0.8)
7 (2.7)
29 (10.4)
13 (4.6)
20 (7.1)
P value
*P <0.01 vs. baseline.
Mean weight at baseline, kg
63.5
64.2
+0.56*
+0.39
0.516
*
Blood Pressure
Continuous LNG/EE
Pill pack 3
*
Satisfactory for evaluation
ASCUS
250
245
Safety Summary
There was no statistical difference in the total number of AEs reported by each study group
Significantly more women reported metrorrhagia
(P <0.001) and vaginal hemorrhage (P = 0.011) in the continuous LNG/EE group
The bleeding-related treatment-emergent AEs that were initially significantly higher for continuous LNG/EE in pill packs 1 to 6 were no longer different by pill packs 7 to 13
During pill packs 7 to 13, women in the
*
Twenty-nine metabolic parameters were assessed and 20 were not significantly different between study groups
Those that were statistically significantly different were not deemed clinically important
These results have been presented elsewhere
*
Continuous LNG/EE demonstrated a similar safety profile to an established 21/7-day cyclic OC
Over time, continuous LNG/EE offered women the ability to achieve amenorrhea and reduce the number of bleeding days
Continuous LNG/EE did not demonstrate clinically important differences compared to the LNG 100/EE 20 cyclic 21/7-day OC in metabolic parameters commonly affected by OCs
There were no on-treatment pregnancies in the continuous LNG/EE group and 3 in the
LNG 100/EE 20 cyclic 21/7-day OC group
0
2
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8
10
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10
20
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50
Headache
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60
80
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Percentage of women
AmenorrheaSpotting onlyBleeding +/- spotting