user experience with an oral contraceptive containing ethinylestradiol 30??g and drospirenone 3mg...

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Treat Endocrinol 2006; 5 (4): 251-256 ORIGINAL RESEARCH ARTICLE 1175-6349/06/0004-0251/$39.95/0 © 2006 Adis Data Information BV. All rights reserved. User Experience with an Oral Contraceptive Containing Ethinylestradiol 30μg and Drospirenone 3mg (Yasmin ® ) in Clinical Practice Beate Schultz-Zehden 1 and Ewald Boschitsch 2 1 Charit´ e Universit¨ atsmedizin Berlin, Center for Human and Health Sciences, Institute of Medical Psychology, Berlin, Germany 2 Ambulatorium KLIMAX, Vienna, Austria Objectives: To assess the reasons why women chose the combined oral contraceptive (COC) containing Abstract ethinylestradiol 30μg and drospirenone 3mg, their perception of it, and their satisfaction with it when used in clinical practice. Methods: This was an uncontrolled survey of women using the ethinylestradiol 30μg/drospirenone 3mg COC in 15 European countries from September to December 2004. The women were invited to participate in this study by their general practitioner, gynecologist, or other family planning provider. The women were asked to complete a four-part questionnaire retrospectively about why they chose the ethinylestradiol 30μg/drospirenone 3mg COC and their experiences with it. Results: A total of 10 947 questionnaires were returned and included in the analysis. Of the respondents, 7694 (70%) had switched to the ethinylestradiol 30μg/drospirenone 3mg COC from other oral contraceptives. About two-thirds (6797 [62%]) of respondents stated that they felt better while using the ethinylestradiol 30μg/ drospirenone 3mg COC compared with the time before they started using it. The severity of premenstrual symptoms including depressed mood, irritability, breast tenderness or pain, abdominal bloating or swelling, skin and hair problems, and swelling of the extremities all improved during treatment with the ethinylestradiol 30μg/ drospirenone 3mg COC. Overall, 10 441 (95%) respondents were satisfied or very satisfied with the ethinylestra- diol 30μg/drospirenone 3mg COC and 9016 (82%) would recommend it to a friend. Conclusion: The additional non-contraceptive benefits of the ethinylestradiol 30μg/drospirenone 3mg COC are important factors that influence patients’ perceptions of this oral contraceptive and their satisfaction with its use. Since their introduction in the 1960s, combined oral contracep- COCs put themselves at increased risk of unintended pregnancies because they incorrectly or inconsistently use them or discontinue tives (COCs) have become the method of choice for the prevention treatment completely. [2-5] of unintended pregnancy for many women in Europe. [1] Moreover, considerable efforts have been made to improve the tolerability Improving rates of the correct and consistent use of COCs is the profile of earlier formulations through reduction of the estrogen joint responsibility of family planning providers, women and, to dose. The introduction of new progestogenic agents that provide some extent, the manufacturers of COCs. [6,7] Minimizing the like- good cycle control, and with minimal adverse effects as well as lihood of unintended pregnancies in women who choose COCs additional non-contraceptive benefits, has also contributed to im- depends on maximizing correct and consistent use and continua- provements in their overall clinical profile. Consequently, women tion rates, and importantly, satisfaction, by selecting a formulation today have a greatly expanded choice of COCs from which to that meets the woman’s requirements. Adequate counseling about select a formulation that most closely meets their preferences and potential treatment-related difficulties, particularly at the start of needs. Nevertheless, a significant number of women who use treatment, as well as awareness of additional non-contraceptive

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Page 1: User Experience with an Oral Contraceptive Containing Ethinylestradiol 30??g and Drospirenone 3mg (Yasmin??) in Clinical Practice

Treat Endocrinol 2006; 5 (4): 251-256ORIGINAL RESEARCH ARTICLE 1175-6349/06/0004-0251/$39.95/0

© 2006 Adis Data Information BV. All rights reserved.

User Experience with an Oral ContraceptiveContaining Ethinylestradiol 30μg andDrospirenone 3mg (Yasmin®) in Clinical PracticeBeate Schultz-Zehden1 and Ewald Boschitsch2

1 Charite Universitatsmedizin Berlin, Center for Human and Health Sciences, Institute of Medical Psychology,Berlin, Germany

2 Ambulatorium KLIMAX, Vienna, Austria

Objectives: To assess the reasons why women chose the combined oral contraceptive (COC) containingAbstractethinylestradiol 30μg and drospirenone 3mg, their perception of it, and their satisfaction with it when used inclinical practice.Methods: This was an uncontrolled survey of women using the ethinylestradiol 30μg/drospirenone 3mg COC in15 European countries from September to December 2004. The women were invited to participate in this studyby their general practitioner, gynecologist, or other family planning provider. The women were asked tocomplete a four-part questionnaire retrospectively about why they chose the ethinylestradiol 30μg/drospirenone3mg COC and their experiences with it.Results: A total of 10 947 questionnaires were returned and included in the analysis. Of the respondents, 7694(70%) had switched to the ethinylestradiol 30μg/drospirenone 3mg COC from other oral contraceptives. Abouttwo-thirds (6797 [62%]) of respondents stated that they felt better while using the ethinylestradiol 30μg/drospirenone 3mg COC compared with the time before they started using it. The severity of premenstrualsymptoms including depressed mood, irritability, breast tenderness or pain, abdominal bloating or swelling, skinand hair problems, and swelling of the extremities all improved during treatment with the ethinylestradiol 30μg/drospirenone 3mg COC. Overall, 10 441 (95%) respondents were satisfied or very satisfied with the ethinylestra-diol 30μg/drospirenone 3mg COC and 9016 (82%) would recommend it to a friend.Conclusion: The additional non-contraceptive benefits of the ethinylestradiol 30μg/drospirenone 3mg COC areimportant factors that influence patients’ perceptions of this oral contraceptive and their satisfaction with its use.

Since their introduction in the 1960s, combined oral contracep- COCs put themselves at increased risk of unintended pregnanciesbecause they incorrectly or inconsistently use them or discontinuetives (COCs) have become the method of choice for the preventiontreatment completely.[2-5]of unintended pregnancy for many women in Europe.[1] Moreover,

considerable efforts have been made to improve the tolerability Improving rates of the correct and consistent use of COCs is theprofile of earlier formulations through reduction of the estrogen joint responsibility of family planning providers, women and, todose. The introduction of new progestogenic agents that provide some extent, the manufacturers of COCs.[6,7] Minimizing the like-good cycle control, and with minimal adverse effects as well as lihood of unintended pregnancies in women who choose COCsadditional non-contraceptive benefits, has also contributed to im- depends on maximizing correct and consistent use and continua-provements in their overall clinical profile. Consequently, women tion rates, and importantly, satisfaction, by selecting a formulationtoday have a greatly expanded choice of COCs from which to that meets the woman’s requirements. Adequate counseling aboutselect a formulation that most closely meets their preferences and potential treatment-related difficulties, particularly at the start ofneeds. Nevertheless, a significant number of women who use treatment, as well as awareness of additional non-contraceptive

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252 Schultz-Zehden & Boschitsch

benefits beyond fertility regulation are important elements in symptoms), and whether these symptoms improved while usinghelping women use COCs more consistently.[6] The role of the the ethinylestradiol 30μg/drospirenone 3mg COC. Other questionsmanufacturer is to provide physicians and other family planning included whether they had ever postponed their menstruation withproviders with comprehensive information on new and existing extended treatment, whether they had experienced changes informulations through robust and well designed clinical trials, post- bodyweight, and those about satisfaction with their current skinmarketing safety surveillance, and post-marketing research, as appearance and bodyweight using a four-grade scale of ‘veryappropriate, so as to enable an informed decision as to which satisfied’, ‘satisfied’, ‘unsatisfied’, and ‘very unsatisfied’. Theformulation to use. Moreover, understanding the reasons why third part included questions about the patient’s general satisfac-women experience difficulties with COCs, and therefore switch tion with the ethinylestradiol 30μg/drospirenone 3mg COC, suchbetween COCs, is an important element in helping to counsel as whether they felt better, worse, or no different compared withthem, and ultimately prescribing formulations that closely match before treatment, how they felt in the week before completing thetheir needs, preferences, and lifestyles. questionnaire (using question nine from the Short Form-36 quali-

ty-of-life questionnaire[14]), their likelihood of switching from theThe COC containing ethinylestradiol 30μg plus drospirenoneethinylestradiol 30μg/drospirenone 3mg COC to another contra-3mg is an effective oral contraceptive that contains a uniqueceptive, and whether they would recommend the ethinylestradiolprogestogen. Drospirenone has, in addition to its progestogenic30μg/drospirenone 3mg COC to a friend. In the fourth part of theactivity, both anti-mineralocorticoid and anti-androgenic proper-questionnaire women were asked about their age, height, andties, unlike other progestogens commonly used in COC formula-bodyweight.tions.[8] Clinical studies have shown it to be an effective COC that

reduces water retention-related weight gain and improves acne The women were instructed to return the completed question-lesions.[9-13] The ethinylestradiol 30μg/drospirenone 3mg COC has naires to the sponsor of the study by mail using prepaid envelopes,now been on the market in >100 countries for over 5 years and or through their respective general practitioner, gynecologist, orsubstantial data regarding its performance in clinical practice are family planning provider. Incentives were given for returning theavailable. The objective of this study was to assess the reasons completed questionnaire. No formal hypotheses were tested in thiswhy women chose the ethinylestradiol 30μg/drospirenone 3mg study and descriptive statistical analyses were calculated.COC, their perception of it, and their satisfaction with it when used

Resultsin clinical practice.

A total of 10 947 questionnaires were returned and included inMethodsthe analysis. Of the respondents, 7694 (70.3%) had switched to the

Women using the ethinylestradiol 30μg/drospirenone 3mg ethinylestradiol 30μg/drospirenone 3mg COC from other oral(Yasmin®; Schering AG, Berlin, Germany)1 COC between 1 Sep- contraceptives, and the other 3253 (29.7%) were considered astember and 31 December 2004 in 15 European countries (Austria, being new starters of oral contraceptives (i.e. women who indicat-Belgium, Czech Republic, Denmark, Finland, France, Germany, ed that they were not using another oral contraceptive immediatelyIceland, Hungary, Netherlands, Norway, Spain, Slovakia, Sweden, prior to the ethinylestradiol 30μg/drospirenone 3mg COC). Al-and the UK) were invited to participate in this study by their though some patients may have given a number of reasons forgeneral practitioner, gynecologist, or other family planning pro- starting or switching to the ethinylestradiol 30μg/drospirenonevider. The women were asked to retrospectively complete a four- 3mg COC, the main reasons included a need for contraceptionpart questionnaire about why they chose the ethinylestradiol 30μg/ (42%; n = 4636), weight gain (30%; n = 3254), and adverse effectsdrospirenone 3mg COC and their experiences with it.2 (25%; n = 2735) associated with the use of other oral contraceptive

The first part of the questionnaire included questions on previ- formulations or methods. Figure 1 summarizes the reasons givenous oral contraceptive usage, reasons for switching to or starting for using the ethinylestradiol 30μg/drospirenone 3mg COC inthe ethinylestradiol 30μg/drospirenone 3mg COC, and the dura- switchers and new starters. Of the new starters, 2505 (77%)tion of its use. The second part included questions on whether the initiated the ethinylestradiol 30μg/drospirenone 3mg COC be-patient suffered from acne or other skin-related symptoms (e.g. cause they needed a contraceptive and 907 (28%) because theyoily skin), or premenstrual symptoms (assessed using a ten-point wanted to regulate their menses (figure 1). The vast majority of allseverity scale from 1 for no symptoms to 10 for extremely severe users (9386; 86%) chose the ethinylestradiol 30μg/drospirenone

1 The use of trade names is for product identification purposes only and does not imply endorsement.2 The full questionnaire is available as supplementary material at http://endocrinology.adisonline.com.

© 2006 Adis Data Information BV. All rights reserved. Treat Endocrinol 2006; 5 (4)

Page 3: User Experience with an Oral Contraceptive Containing Ethinylestradiol 30??g and Drospirenone 3mg (Yasmin??) in Clinical Practice

User Experience with Ethinylestradiol 30μg/Drospirenone 3mg OC 253

0 5 10 15 20 25 30 35 40 45

Don't know

Other reasons

Recommendation of a friend

To regulate my menstrual cycle

Weight gain with other method or pill

Hope that the pill will improve skin and hair

Did not tolerate the other pill

Experienced adverse effects with other pill

Health concerns

Want a more effective method

Contraceptive need

0 10 20 30 40 50 60 70 80 90

Proportion of women (%)

ba

Fig. 1. Reasons for using the ethinylestradiol 30μg/drospirenone 3mg combined oral contraceptive in (a) switchers (n = 7694) and (b) new starters (n =3253). Some women may have given more than one reason for using the oral contraceptive from the list of possible reasons supplied.

3mg COC because it was recommended to them by their family from any symptoms in the days preceding their menses. Overall,planning provider. At the time of completing the questionnaire depressed mood, irritability, breast tenderness or pain, abdominal5105 (47%) women were aged between 21 and 30 years. The bloating or swelling, or skin and hair problems were reported bymajority of women (75%) had been using the ethinylestradiol 52–66% of respondents prior to initiating treatment. Swelling of30μg/drospirenone 3mg COC for <2 years: 2823 (26%) for 1–6 the extremities such as hands and ankles was reported by 4093months, 1742 (16%) for 7–11 months, and 3594 (33%) for 1 to ≤2 (37%) respondents. The mean individual symptom scores wereyears. significantly (p < 0.001 for the Sign test and Wilcoxon signed-rank

test) reduced with the ethinylestradiol 30μg/drospirenone 3mgAbout one-third (37%; n = 4098) of respondents stated that theyCOC compared with the time before its use (figure 2). The greatesthad acne or related skin problems before starting the ethinyles-improvements occurred for skin and hair problems, abdominaltradiol 30μg/drospirenone 3mg COC; of these, 3050 (74%) report-bloating or swelling, breast tenderness or pain, and swelling of theed that their skin condition had improved since they started treat-extremities.ment. There was little difference in responses between new starters

and those women who had switched from another oral contracep- When questioned about their satisfaction with their currenttive to the ethinylestradiol 30μg/drospirenone 3mg COC. The bodyweight whilst receiving treatment, 8117 (74%) respondentsproportion of women who reported improvement in their skin stated that they were satisfied or very satisfied with theircondition increased with the duration of use up to 7 months, and bodyweight. When further questioned about bodyweight changesthe proportion of women who did not report improvement de- compared with the time before they were using the ethinylestradiolcreased (data not shown). Moreover, 9883 (90%) women were 30μg/drospirenone 3mg COC, the vast majority (n = 8535; 78%)satisfied or very satisfied with the current appearance of their skin, stated that they had either experienced no change or a weightincluding 3496 (85%) of those who stated that they had acne or reduction (figure 3). Some weight gain was reported by 1838related skin problems when they started treatment. In addition, (17%) women. Of the women who used the ethinylestradiol 30μg/3742 (34%) respondents had extended their active treatment regi- drospirenone 3mg COC for up to 6 months, 933 of 2823 (33%) lostmen (prolonged the duration of active treatment) in order to weight and of those who used the ethinylestradiol 30μg/drospire-postpone menstruation. none 3mg COC for up to 1 year, 1337 of 3594 (37%) lost weight.

Thereafter, the proportion of women who reported weight lossAlmost all of the respondents had experienced some premen-decreased gradually with every subsequent year of use. Moreover,strual symptoms in the days preceding their menses prior toof the respondents who had switched to the ethinylestradiol 30μg/initiating the ethinylestradiol 30μg/drospirenone 3mg COC. Onlydrospirenone 3mg COC because of weight problems associatedapproximately 4% of respondents stated that they did not suffer

© 2006 Adis Data Information BV. All rights reserved. Treat Endocrinol 2006; 5 (4)

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254 Schultz-Zehden & Boschitsch

0

1

2

3

4

5

6

7

8

9

10

Depressedmood

Irritability Breasttenderness/

pain

Abdominalbloating/swelling

Skin and hairproblems

Swelling ofextremities

Sco

re

BeforeDuring

Fig. 2. Mean premenstrual symptom rating during use of the ethinylestradiol 30μg/drospirenone 3mg combined oral contraceptive compared with beforeinitiation of this contraceptive (1 = not experienced; 10 = extremely severe). All individual symptoms were significantly reduced (p < 0.001).

with their previous oral contraceptive method, 1804 of 2955 (61%) different. Consistent with the improved well-being, 10 441 (95%)respondents were satisfied or very satisfied with the ethinylestradi-stated that they had lost weight while using it, whereas 129 of 299ol 30μg/drospirenone 3mg COC (figure 4), with no difference in(43%) new starters lost weight (p < 0.001 for the Pearson Chi-response between switchers and new starters. In addition, 9501square test).(87%) respondents were unlikely or very unlikely to switch from

The ethinylestradiol 30μg/drospirenone 3mg COC had a posi-the ethinylestradiol 30μg/drospirenone 3mg COC, and 9016

tive effect on the respondents’ well-being with 6797 (62%) report-(82%) would recommend it to a friend.

ing that they felt better during its use compared with how they hadfelt during the time before treatment initiation. Interestingly, two-

Discussionthirds of respondents who had switched to the ethinylestradiol30μg/drospirenone 3mg COC felt better with treatment compared This Europe-wide study provides a valuable insight into pa-with approximately half of new starters; the majority of the others tients’ perception of the ethinylestradiol 30μg/drospirenone 3mg(30% of switchers and 44% of new starters), did not feel any COC and satisfaction with the product in clinical practice. Overall,

the vast majority of respondents were satisfied or very satisfiedwith the ethinylestradiol 30μg/drospirenone 3mg COC, and re-ported additional tangible benefits with regard to water retention-related symptoms, acne and other skin-related problems, andpremenstrual symptoms in general. These non-contraceptive bene-fits are consistent with the known pharmacology of the ethinyles-tradiol 30μg/drospirenone 3mg COC, and drospirenone in particu-lar. Indeed, the main reasons of experienced users of oral contra-ceptives for switching to the ethinylestradiol 30μg/drospirenone3mg COC were because of weight gain (39%) and the adverseeffects associated with other methods (33%). In contrast, the mainreasons given by new starters of oral contraceptives for choosingthe ethinylestradiol 30μg/drospirenone 3mg COC were contracep-tive protection (77%) and to regulate menstruation (28%). Thediscrepancies in the reasons given for choosing the ethinylestradi-ol 30μg/drospirenone 3mg COC between new starters and switch-ers may reflect that women initiate oral contraceptive usage prima-

0 10 20 30 40 50 60 70 80 90 100

Newstarters

Switchers

All users

Proportion of respondents (%)

Lost weightNo changeGained weightNo reponse/don’t know

Fig. 3. Summary of the perception of the bodyweight changes experiencedwith the ethinylestradiol 30μg/drospirenone 3mg combined oral contracep-tive.

© 2006 Adis Data Information BV. All rights reserved. Treat Endocrinol 2006; 5 (4)

Page 5: User Experience with an Oral Contraceptive Containing Ethinylestradiol 30??g and Drospirenone 3mg (Yasmin??) in Clinical Practice

User Experience with Ethinylestradiol 30μg/Drospirenone 3mg OC 255

rily for fertility control and the associated menstrual regulation, after with every subsequent year of use – a trend that is consistentbut once they become experienced with the use of oral contracep- with data obtained in clinical studies.[9-11] Moreover, a highertives and their associated issues, then benefits beyond contracep- proportion of switchers reported that they experienced weighttive protection become important aspects to consider. Neverthe- reduction compared with new starters. However, it is important toless, although the findings of this study may not be generalized to note that the ethinylestradiol 30μg/drospirenone 3mg COC shouldother COCs, they suggest that choosing an appropriate oral contra- not be used as a weight reduction method because the weightceptive with additional benefits will achieve high satisfaction reduction associated with its use does not represent true weightratings (95% were satisfied or very satisfied with the ethinyles- loss associated with fat loss. Nevertheless, water retention-relatedtradiol 30μg/drospirenone 3mg COC) among both new starters weight reduction has been confirmed as a beneficial aspect of theand switchers of oral contraceptives. By comparison, clinical clinical profile of the ethinylestradiol 30μg/drospirenone 3mgstudies with other COCs have shown satisfaction ratings (propor- COC. Indeed, a survey of the contraceptive use and behavior oftions of recipients who were satisfied or very satisfied with treat- women aged 15–49 years across five European countries foundment) ranging between 65% and 86%.[15,16] The results of our that approximately 8% of respondents discontinued oral contra-survey are consistent with those of another survey in three Euro- ceptive use because of weight gain.[1] This discontinuation rate ispean countries (Belgium, Germany, and The Netherlands), which much lower than the 39% of switchers choosing the ethinylestradi-showed that women who took the ethinylestradiol 30μg/drospire- ol 30μg/drospirenone 3mg COC because of weight gain associatednone 3mg COC for a trial period felt worse once they returned to with their previous contraception in this study. This discrepancytheir usual formulation.[17]

can, in part, be explained by differences in the populations sur-The additional non-contraceptive benefits of the ethinylestradi- veyed – our survey assessed only women who actively changed

ol 30μg/drospirenone 3mg COC reflect the anti-mineralocorticoid their oral contraceptive while the other European survey[1] includ-and anti-androgenic properties of drospirenone. The beneficial ed women who were not currently using oral contraceptives.anti-mineralocorticoid effect of the ethinylestradiol 30μg/dros-

The participants in this study were not selected on the basis ofpirenone 3mg COC on water retention-related weight gain has

their skin condition; however, the vast majority of those whobeen demonstrated in three large efficacy studies.[9-11] In these

reported that they had skin problems before starting the ethinyles-clinical studies, the majority of women who took the ethinyles-

tradiol 30μg/drospirenone 3mg COC stated that their skin condi-tradiol 30μg/drospirenone 3mg COC for up to 2 years either

tion had improved since taking it. Moreover, 90% of respondentsmaintained their initial bodyweight or experienced a small reduc-

were satisfied or very satisfied with the current appearance of theirtion in bodyweight, particularly during the first cycles of use. Thisskin while receiving this oral contraceptive. The results of thisstudy confirms the beneficial effect of the ethinylestradiol 30μg/study are consistent with those of well controlled studies showingdrospirenone 3mg COC on water retention-related weight gain inthat the ethinylestradiol 30μg/drospirenone 3mg COC has a bene-the vast majority of women in clinical practice. A higher propor-ficial effect on acne in young women.[10,12,13] Moreover, thetion of women lost weight during the first year of use and theethinylestradiol 30μg/drospirenone 3mg COC has been shown toproportion of women who lost weight decreased gradually there-reduce sebum production and hair growth on the upper lip andchin, as well as increasing sex hormone-binding globulin levelsand decreasing androgen levels.[13] Indeed, the ethinylestradiol30μg/drospirenone 3mg COC has been shown to be at least aseffective as an oral contraceptive containing cyproterone,[13] butsuperior to a triphasic contraceptive containing norgestimate,[12]

making it a good option for women with acne and other skin-related problems who require contraception.

In this study, the average severity score for the premenstrualsymptoms experienced, including depression, irritability, breasttenderness or pain, abdominal bloating or swelling and swelling ofthe extremities, all decreased with ethinylestradiol 30μg/drospire-none 3mg oral contraceptive treatment compared with before itsuse. These results are consistent with the positive effects of theethinylestradiol 30μg/drospirenone 3mg COC on individual

0

10

20

30

40

50

60

Verysatisfied

Satisfied Unsatisfied Veryunsatisfied

Noanswer

Pro

port

ion

of p

atie

nts

(%)

Fig. 4. Respondent satisfaction with the ethinylestradiol 30μg/drospirenone3mg combined oral contraceptive.

© 2006 Adis Data Information BV. All rights reserved. Treat Endocrinol 2006; 5 (4)

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256 Schultz-Zehden & Boschitsch

3. Rosenberg MJ, Waugh MS. Oral contraceptive discontinuation: a prospectivepremenstrual symptoms that have been demonstrated in clinicalevaluation of frequency and reasons. Am J Obstet Gynecol 1998; 179: 577-82

studies.[11,18,19]4. Potter LS. Oral contraceptive compliance and its role in the effectiveness of the

method. New York: Raven Press Ltd, 1991This survey has a number of limitations that need to be consid-5. Potter L, Oakley D, de Leon-Wong E, et al. Measuring compliance among oralered when assessing its relative generalizability. It was not clear

contraceptive users. Fam Plann Perspect 1996; 28 (4): 154-8whether some of the participating family planning providers who

6. Rosenberg MJ, Waugh MS, Burnhill MS. Compliance, counseling and satisfactiondistributed the questionnaires were selective in their distribution. with oral contraceptives: a prospective evaluation. Fam Plann Perspect 1998; 30

(2): 89-92, 104As an uncontrolled, retrospective before and after survey, the7. Heinemann LA, Thiel C, Assmann A, et al. Frequency and reasons for switching/effect of other possible confounders that may affect patients’

stopping use of oral contraceptives: results of the German Cohort Study onperception of the product, and therefore, satisfaction, could not beWomen Health. Zentralbl Gynakol 2001; 123 (10): 568-77

evaluated. In addition, it is unclear what proportion of question-8. Krattenmacher R. Drospirenone: pharmacology and pharmacokinetics of a unique

naires distributed to patients were completed and returned for progestogen. Contraception 2000 Jul; 62 (1): 29-38

inclusion in the analysis as this was not recorded – a lack of 9. Foidart J-M, Wuttke W, Bouw GM, et al. A comparative investigation of contra-ceptive reliability, cycle control and tolerance of two monophasic oral contra-motivation to complete and return the form by those with negativeceptives containing either drospirenone or desogestrel. Eur J Contracept Reprod

experiences would likely bias the data in favor of the ethinyles- Health Care 2000; 5 (2): 124-34

tradiol 30μg/drospirenone 3mg COC. The exclusion of ex-users of 10. Huber J, Foidart JM, Wuttke W, et al. Efficacy and tolerability of a monophasicoral contraceptive containing ethinylestradiol and drospirenone. Eur J Con-the ethinylestradiol 30μg/drospirenone 3mg COC from participa-tracept Reprod Health Care 2000; 5 (1): 25-34

tion may also have biased the data towards the collation of more11. Parsey KS, Pong A. An open-label, multicenter study to evaluate Yasmin, a low-favorable responses. Moreover, for patients who switched from dose combination oral contraceptive containing drospirenone, a new proges-

togen. Contraception 2000; 61 (2): 105-11one product to another, there may be a tendency to link improve-ments in symptoms (such as acne, weight gain, premenstrual 12. Thorneycroft IH, Gollnick H, Schellschmidt I. Superiority of a combined oral

contraceptive containing drospirenone to a triphasic preparation containingsymptoms) retrospectively to the new product when prompted.norgestimate in acne treatment. Cutis 2004; 74: 123-30

Nevertheless, the results of this study give us a valuable insight13. van Vloten WA, van Haselen CW, van Zuuren EJ, et al. The effect of 2 combined

into which product characteristics likely influence patients’ satis- oral contraceptives containing either drospirenone or cyproterone acetate onacne and seborrhea. Cutis 2002; 69 Suppl. 4: 2-15faction with oral contraceptives.

14. Medical Outcomes Trust and QualityMetric Incorporated. SF-36 health surveyIn conclusion, the perception and satisfaction of women receiv- [online]. Available from URL: http://www.sf-36.org/tools/pdf/SF-

36v1_Standard_Sample.pdf [Accessed 2006 Apr 11]ing a COC are likely to be influenced by additional non-contracep-15. Poindexter AN, Burkman R, Fisher AC, et al. Cycle control, tolerability, andtive benefits. In this respect, the ethinylestradiol 30μg/drospire-

satisfaction among women switching from 30–35 microg ethinyl estradiol-none 3mg COC appears to offer a number of advantages compared containing oral contraceptives to the triphasic norgestimate/25 microg ethinylestradiol-containing oral contraceptive Ortho Tri-Cyclen LO. Int J Fertilwith other low-dose COCs.Womens Med 2003; 48 (4): 163-72

16. Sulak P, Lippman J, Siu C, et al. Clinical comparison of triphasic norgestimate/35micrograms ethinyl estradiol and monophasic norethindrone acetate/20 micro-Acknowledgmentsgrams ethinyl estradiol: cycle control, lipid effects, and user satisfaction.Contraception 1999; 59 (3): 161-6

17. Boschitsch E, Skarabis H, Wuttke W, et al. The acceptability of a novel oralFunding for this study was provided by Schering AG, Berlin, Germany.contraceptive containing drospirenone and its effect on well-being. Eur JEditorial assistance for the development of this manuscript was provided byContracept Reprod Health Care 2000; 5 Suppl. 3: 34-40Richard Glover, with the financial support of Schering AG. Dr Schultz-

18. Freeman EW, Kroll R, Rapkin A, et al. Evaluation of a unique oral contraceptive inZehden has received honoraria from Schering AG. The authors have nothe treatment of premenstrual dysphoric disorder. J Womens Health Gendconflicts of interest that are directly relevant to the content of this study.Based Med 2001; 10 (6): 561-9

19. Brown C, Ling F, Wan J. A new monophasic oral contraceptive containingdrospirenone: effect on perimenstrual symptoms. J Reprod Med 2002; 47 (1):14-22References

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schaften, Institut fur Medizinische Psychologie, Habelschwerdter Allee 45,2. Rosenberg MJ, Waugh MS, Long S. Unintended pregnancies and use, misuse anddiscontinuation of oral contraceptives. J Reprod Med 1995 May; 40 (5): 355-60 Berlin, 14195, Germany.

© 2006 Adis Data Information BV. All rights reserved. Treat Endocrinol 2006; 5 (4)