Abstract
Objective(s)
To investigate the bleeding pattern and cycle control parameters of a contraceptive
patch containing 0.55mg ethinyl estradiol (EE) and 2.1mg gestodene (GSD) compared with a patch containing 0.6mg EE and 6mg norelgestromin (NGMN).
Study design
In this phase III, open-label, randomized, parallel-group trial, healthy women aged
18–35 years (smokers aged 18–30 years) received either the EE/GSD patch (n=200) or the EE/NGMN patch (n=198). Treatment consisted of one patch per week for 3 weeks followed by a 7-day, patch-free
interval for seven cycles. Bleeding control was assessed in two 90-day reference periods.
Results
In reference period 1, mean number of bleeding/spotting days was comparable across
treatment groups (p>0.05). However, in reference period 2, there were fewer bleeding/spotting
days in the EE/GSD patch group (15.7 versus 18.4; p<0.0001). Mean number of bleeding/spotting
episodes was comparable across groups for both reference periods, but bleeding/spotting
episodes were shorter for the EE/GSD patch than the EE/NGMN patch during reference
period 1 (5.13 days versus 5.53 days, respectively; p<0.05) and reference period 2
(5.07 versus 5.66; p=0.0001). Both treatment groups showed a similar frequency of
withdrawal bleeding episodes; however, across all seven cycles, the length of these
episodes was consistently shorter with the EE/GSD patch (p<0.01). There were no notable
treatment differences in intracyclic bleeding.
Conclusion(s)
Bleeding pattern and cycle control achieved with the EE/GSD patch was similar to that
of the EE/NGMN patch.
Implications statement
The paper presents data on the bleeding pattern and cycle control parameters of an
investigational transdermal contraceptive patch containing EE and GSD compared with
an approved contraceptive patch containing EE and NGMN. This descriptive study found
that bleeding patterns associated with the EE/GSD patch were similar to those of an
EE/NGMN patch providing higher EE exposure.
Keywords
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References
- World contraceptive use 2011.(Available at:) (Last accessed: 23 September 2014)
- The Coraliance study: non-compliant behavior. Results after a 6-month follow-up of patients on oral contraceptives.Eur J Contracept Reprod Health Care. 2004; 9: 267-277
- Pharmacology of estrogens and progestogens: influence of different routes of administration.Climacteric. 2005; : 3-63
- Intra- and interindividual variations in contraceptive steroid levels during 12 treatment cycles: no relation to irregular bleedings.Contraception. 1990; 42: 423-438
- Pharmacokinetics of ethinyl estradiol and mestranol.Am J Obstet Gynecol. 1990; 163: 2114-2119
- Transdermal hormonal contraception: benefits and risks.Am J Obstet Gynecol. 2007; 197: 134.e1-134.e6
- Combined ethinylestradiol/gestodene contraceptive patch: two-center, open-label study of ovulation inhibition, acceptability and safety over two cycles in female volunteers.Eur J Contracept Reprod Health Care. 2004; 9: 173-181
- Are all estrogens the same?.Maturitas. 2004; 47: 269-275
- Prospective, open-label, noncomparative study to assess cycle control, safety and acceptability of a new oral contraceptive containing gestodene 60 microg and ethinylestradiol 15 microg (Minesse).Contraception. 2006; 73: 30-33
- Desogestrel, norgestimate, and gestodene: the newer progestins.Ann Pharmacother. 1995; 29: 736-742
- Gestodene. A review of its pharmacology, efficacy and tolerability in combined contraceptive preparations.Drugs. 1995; 50: 364-395
- Clinical profile of contraceptive progestins.Eur J Contracept Reprod Health Care. 2004; 9: 182-193
- Abnormal uterine bleeding associated with hormonal contraception.Am Fam Physician. 2002; 65: 2073-2080
- Pharmacokinetic overview of ethinyl estradiol dose and bioavailability using two transdermal contraceptive systems and a standard combined oral contraceptive.Int J Clin Pharmacol Ther. 2014; https://doi.org/10.5414/CP202064
- A comparison of bleeding patterns and cycle control using two transdermal contraceptive systems: a multicenter, open-label, randomized study.in: Poster presented at European Society for Human Reproduction and Embryology Annual Meeting, London, United Kingdom. 7–10 July 2013
- Bleeding pattern and cycle control with an estradiol-based oral contraceptive: a seven-cycle, randomized comparative trial of estradiol valerate/dienogest and ethinyl estradiol/levonorgestrel.Contraception. 2009; 80: 436-444
- Bleeding pattern and cycle control of a low-dose transdermal contraceptive patch compared with a combined oral contraceptive: a randomized study.Contraception. 2014; https://doi.org/10.1016/j.contraception.2014.10.004
- Bleeding pattern with drospirenone 3mg+ethinyl estradiol 20 mcg 24/4 combined oral contraceptive compared with desogestrel 150 mcg+ethinyl estradiol 20 mcg 21/7 combined oral contraceptive.Contraception. 2009; 80: 445-451
- Effect of a low-dose contraceptive patch on efficacy, bleeding pattern, and safety: a 1-year, multicenter, open-label, uncontrolled study.Reprod Sci. 2014; https://doi.org/10.1177/1933719114532840
- Recommendations for standardization of data collection and analysis of bleeding in combined hormone contraceptive trials.Contraception. 2007; 75: 11-15
Article info
Publication history
Published online: October 10, 2014
Accepted:
October 4,
2014
Received in revised form:
September 25,
2014
Received:
December 20,
2013
Footnotes
☆Submitted as a companion paper to Merz et al. ‘Bleeding pattern and cycle control of a low-dose transdermal contraceptive patch compared with a combined oral contraceptive: a randomized study’.
☆☆Registration no. NCT00984789.
★Acknowledgement of funding. This study was funded by Bayer Pharma AG, Berlin, Germany. Editorial assistance for the manuscript was provided by Ogilvy 4D, Oxford, UK, and also funded by Bayer Pharma AG, Berlin, Germany.
★★Financial disclosures. Doris Gruber has no relevant financial interests to declare. Aleš Skřivánek has no relevant financial interests to declare. Marco Serrani, Vivian Lanius and Martin Merz are salaried employees of Bayer Pharma AG, Berlin, Germany.
Identification
Copyright
© 2015 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
