Pii: s0010-7824(02)00314-

Attitudes and experiences with levonorgestrel 100 ␮g/ethinyl estradiol 20 ␮g among women during a 3-month trial Yolanda H. Wimberlya, Sian Cottona, Abbey M. Wanchicka, Paul A. Succopb, aDepartment of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA bDepartment of Environmental Health, University of Cincinnati College of Medicine, Cincinnati, OH, USA cDepartment of Pediatrics, University of Texas Medical Branch, Galveston, TX, USA Received 10 November 2001; received in revised form 29 January 2002; accepted 5 March 2002 Abstract
To describe attitudes and experiences with a low-dose oral contraceptive pill (Alesse) over 3 months, women aged 18 years and older (n ϭ 218) were enrolled from 16 locations to evaluate their experiences with Alesse. The questionnaire assessed demographic and personalcharacteristics, attitudes and experiences, and satisfaction. The participants had a mean age of 26.7 years and most were single, Caucasian,had completed high school, had a regular sexual partner, and had previously used OCs. Sixty percent of participants could discuss pill useeasily with their mothers, 92% with friends, and 96% with partners; 45% of the women were unsure about their mother’s previous OC use.
Of the 11 side effects assessed, the most frequently anticipated side effect was weight gain. There was a significant relationship betweenanticipated and reported side effects for weight and mood changes; however, there remained a number of women for whom these differed.
Most (90%) were satisfied with Alesse. Even when beginning on 20 ␮g pills, some women may still anticipate side effects such as weightgain typically associated with higher doses of estrogen. Healthcare providers should assess women’s attitudes and anticipated experienceswith OCs and counsel accordingly. 2002 Elsevier Science Inc. All rights reserved.
Keywords: Oral contraceptive pills; Contraception; Satisfaction; Women’s health; Side effects; Weight gain; Levonorgestrel 1. Introduction
2. Describe anticipated and reported side effects with 100 ␮g LNG and 20 ␮g EE (Alesse) at 3 months in The present study assessed attitudes and experiences of adult women, aged 18 years and over, participating in a 3. Describe women’s satisfaction with 100 ␮g LNG and multisite 3-month clinical trial of a low dose OC with 100 20 ␮g EE OC (Alesse) and determine if previous OC ␮g levonorgestrel (LNG) and 20 ␮g EE (Alesse). This use, having a steady partner, and reported side effects formulation contains the lowest doses of LNG and EE available in a monophasic OC and was designed to maintainoptimal contraceptive efficacy of 99% with appropriate us-age and decrease side effects, while providing noncontra-ceptive benefits (i.e., increased cycle regularity, lighter 2. Materials and methods
flow). The specific aims of the current study were to: Two-hundred-eighteen women recruited from their phy- 1. Describe knowledge of the participants’ mothers’ OC sicians’ offices were enrolled from 16 locations (Philadel- use, ease with discussing OC use, and partner support phia, PA; New Brunswick, NJ; Chicago, IL (2 sites); Char- lotte, NC; Albuquerque, NM; Miami Lakes, FL; London,Ontario; Galveston, TX; Tucson, AZ; Seattle, WA; Am-arillo, TX; Minneapolis, MN; Montreal, Quebec; Houston, * Corresponding author. Tel.: ϩ1-409-772-1594; fax: ϩ1-409-747- TX; and Pittsburgh, PA) to participate in an outpatient, open E-mail address: susan.rosenthal@utmb.edu (S.L. Rosenthal).
label, multicenter study. Each site had Institutional Review 0010-7824/02/$ – see front matter 2002 Elsevier Science Inc. All rights reserved.
PII: S 0 0 1 0 - 7 8 2 4 ( 0 2 ) 0 0 3 1 4 - 1 Y.H. Wimberly et al. / Contraception 65 (2002) 403– 406 Board approval, and informed consent was obtained from Each site recruited healthy, premenopausal female sub- jects 18 years of age and older, and who were determined to be appropriate to receive an OC by their physician. Exclu- sion criteria included: contraindications to OC use, over 35 years of age, cigarette smoker, breast feeding, postpartum less than 3 months, use of OC or Norplant system within the last 3 months, less than 6 months from last injection of Depo-Provera, use of investigational drug within past 60 days, use of rifampin, anticonvulsants, or griseofulvin dur- ing past 3 months, or using OC exclusively for cycle con- At the baseline visit, each participant had height and weight recorded and was instructed to complete the initial questionnaire. Upon establishing the presence of inclusion criteria and the absence of exclusion criteria, the participant was given pill-taking instructions and informed to begin Cycle 1 with her next menstrual bleed. The participant was instructed to record her pill-taking, adverse events, and concomitant medications in her subject diary card. At the end of Cycle 3, the same procedure was followed and a 3-month questionnaire was completed.
The baseline questionnaire was divided into three sec- tions that inquired about general demographic and personal characteristics, attitudes of significant others, and side ef-fects. The participants were asked whether they anticipatedexperiencing “less,” “same,” or “more” of any of the fol- used to compare previous OC use, steady current partner, lowing side effects: length of period, menstrual flow, men- strual spotting or bleeding, sexual desire, body weight,upset stomach/nausea, vomiting, acne, headaches, breast 3. Results
tenderness, and mood changes. The 3-month questionnaireasked the participants to report side effects experienced and satisfaction. For purposes of analysis, anticipating or report-ing “less” symptoms was collapsed with anticipating or The demographic characteristics of the 218 participants reporting the “same” degree of symptoms, and then was are listed in Table 1. The mean age was 26.7 years. The compared to “more” symptoms. The one exception was majority of participants were single, Caucasian, had com- “sexual desire,” for which “less” was compared to a col- pleted high school, had a regular sexual partner, and had lapsed category of “more” or the “same.” The Statistical Analysis System (SAS) [1] was used to Of the 218 participants, 169 (78%) completed the perform statistical analyses. Descriptive statistics were used 3-month visit. Reasons for noncompletion by the 49 women to describe the participants. Differences in demographic and were: 6 for medical reasons, 3 for accidental pregnancies, 3 personal characteristics between completers and noncompl- for personal reasons, 27 failed to return for follow-up, and eters were analyzed using contingency tables and analysis 10 had no 3-month data collected by their site investigator.
of variance procedures. Descriptive statistics were per- Demographic characteristics (age, race/ethnicity, marital formed to describe their perceptions of the attitudes of status, education, and previous OC use) were compared significant others and their reported side effects and satis- between completers and noncompleters (see Table 1). Be- faction. Those side effects for which more than 80% of cause of the small sample size, race/ethnicity was collapsed individuals anticipated fewer or no side effects (for sexual into White versus non-White. No significant differences desire—increase or no change) were not included in anal- were found for any of the comparisons.
yses as there was not sufficient variance to evaluate rela-tionships. To evaluate the relationship between anticipated 3.2. Knowledge of mothers’ OC use, ease with and reported side effects, percent agreement and a Kappa discussions of use, and partner support for OC use statistic were used. The Landis and Koch [2] criteria fordetermining the level of agreement (“excellent,” “good,” With regards to knowledge of their mothers’ OC use, 98 and “marginal”) was used. A contingency table analysis was (45%) women were unsure, 67 (31%) reported that their Y.H. Wimberly et al. / Contraception 65 (2002) 403– 406 Number (%) of participants’ anticipated and reported side effects (n ϭ 169) Percent agreement/Kappa for each side effect a One subject did not answer the question.
a Significant, 95% confidence interval does not include zero.
mothers had used OCs, and 53 (24%) reported that theirmothers had not used OCs. The participants were asked if they could easily discuss their feelings about pill use withparents, friends, and partners. Among completers and non- One-hundred (60%) participants were very satisfied, 52 completers (N ϭ 218), the following percent of participants (31%) were somewhat satisfied, and 16 (9%) were not at all answered positively: 60% with parents (119/199); 92% with satisfied with Alesse. In addition, 156 (93%) of those who friends (201/218); and 96% with partners (181/189). When were very or somewhat satisfied were likely to recommend asked about partners’ attitudes toward OC use, 90% (165/ Alesse to a friend. For those women who had previously 183) stated that their partner agreed with their OC use, 1% used OCs (n ϭ 123), 105 (85%) liked Alesse more than or (2/183) reported partners disagreed, and 9% (16/183) were not sure of their partners’ attitudes.
The women who were “very satisfied” and “somewhat 3.3. Anticipated and reported side effects satisfied” at 3 months were then collapsed into one groupand compared with those who were “not at all” satisfied.
The anticipated and side effects reported by the 168 There was no significant relationship between satisfaction participants who completed the questions on side effects are with Alesse and having used OCs previously or having a listed in Table 2. One participant did not complete the regular partner. Satisfaction was compared between less/ symptom questions at either baseline or at 3 months. Of the same and more side effects for the five side effects (men- 11 side effects, menstrual spotting or bleeding, body weight, strual spotting or bleeding, body weight, upset stomach/ upset stomach/nausea, breast tenderness, and mood changes nausea, breast tenderness, and mood changes) for which met the criteria of having more than 20% or more of par- more than 20% of the participants reported side effects (see ticipants anticipating an increase. The percent agreement Table 4). The only significant relationship was that fewer and Kappa statistic for each of these five side effects are participants were satisfied who reported upset stomach/nau- presented in Table 3. These results indicate that the percent sea than anticipated experiencing upset stomach/nausea.
agreement ranges from 60% to 92%. The Kappa statistic,which controls for chance agreement, only indicated “mar-ginal” (Ͻ0.40) agreement for each of the side effects. How- ever, the Kappa for body weight and mood changes was Number (%) of participants who reported either less/same or more side significant (i.e., the 95% confidence interval does not in- clude zero). This indicates that there was agreement be- tween anticipated and reported body weight and mood changes; that is, more participants had anticipated and re- ported the same thing than would be expected by chance.
Two participants declined to be weighed. Fifty-eight (35%) participants actually gained weight as defined by two or more pounds (mean ϭ 6.16 lbs, range 2 to 16) and 37 (22%) lost weight (mean ϭ 4.78 lbs, range 2 to 14 lbs).
Y.H. Wimberly et al. / Contraception 65 (2002) 403– 406 4. Discussion
this visit or during previous OC experiences). However,because all women starting on OCs should receive counsel- Oral contraceptive pills are a primary method women use ing, this might mirror the real world of OC use. Another to prevent pregnancy [3], yet OC use remains fraught with limitation is the inability to discern if attitudes and experi- misconceptions. This study examined the experiences of ences with OC use vary by race/ethnicity because of the women taking a low dose OC with 100 ␮g LNG and 20 ␮g small numbers of Hispanic and African-American women EE (Alesse) in a multisite study and found that, in general, the women were satisfied with Alesse.
Despite these limitations, the result of this multisite study Being prepared for the physical changes associated with showed that women are satisfied with a low dose pill such OC use, particularly those that may be transient, may lead to as Alesse (20 ␮g). Some women may still anticipate side greater OC satisfaction. Also, reduction of side effects is effects typically associated with higher doses of estrogen, important to women to increase both adherence and satis- and there is little agreement between anticipated side effects faction. However, as evidenced by the results of this study, and reported side effects at 3 months. Future studies should the nature of these relationships is unclear. This is likely examine the impact of counseling focused on women’s because of the fact that individual women’s tolerance for anticipated and reported experiences to determine if this side effects varies, there are different levels of motivation impacts continued use and satisfaction with their OC.
for OC use, and the meaning of satisfaction with contracep-tion is not well defined and differs among women. Largetrials are needed to have sufficient sample size to investigate Acknowledgments
the subtleties of all of these relationships. This is especiallytrue given the small number of women who anticipate and The authors would like to acknowledge the support of experience side effects on the low dose formulations.
Wyeth-Ayerst Pharmaceuticals, Deborah Stewart, and Jen- Weight is a salient issue for most American women. Two nifer Fende for their data collection and management sup- randomized placebo-controlled trials comparing a 20 ␮g pill port, Linda Potter, Ph.D. for her helpful editorial comments and placebo demonstrated similar changes in mean body and the site investigators: Gloria Bachmann, M.D., Kurt weight from baseline between participants in each group Barnhart, M.D., Eric Bieber, M.D., Abbey Berenson, M.D., with a mean change in weight less than 1 kg for both groups Mitchell Creinin, M.D., Richard Derman, M.D., Frank Har- [4]. Despite these findings, women remain concerned about rison, M.D., M. Wayne Heine, M.D., John C. Jennings, weight gain (e.g., 42% in this sample) before starting on M.D., Mark Martens, M.D., Carlos Medina, M.D., Leslie OCs. Most of the women in our study (43%) experienced no Miller, M.D., Michelle Miller, M.D., Alfred Poindexter III, change in body weight, and women both lost (22%) and M.D., Elizabeth Smith, M.D., and Daniel Wiener, M.D.
gained weight (35%). This study was not designed to eval-uate weight change as a result of OC use, in that diet was not References
monitored, other reasons for losing or gaining weight werenot assessed, and there was no comparison group. However, [1] SAS Institute. SAS/STAT User’s Guide. Cary NC: SAS Institute, these results support others’ findings [5] about the impor- tance of addressing the weight concerns of some OC users, [2] Landis JR, Koch GG. An application of hierarchical kappa-type since 97 (58%) women in this study anticipated and/or statistics in the assessment of majority agreement among multiple experienced body weight gain during the 3 months.
observers. Biometrics 1977;33:366 –74.
[3] Rosenberg MJ, Meyers A, Roy V. Efficacy, cycle control, and side These women were comfortable discussing pill use with effects of low-, and lower-dose oral contraceptives: a randomized trial friends and partners, but they knew very little about their of 20 ␮g and 35 ␮g estrogen preparations. Contraception 2000;60: mothers’ own personal experiences with OC use. Adoles- cent girls’ choice of contraception has been found to be [4] Coney P, Washenik K, Langley R, DiGiovanna J, Harrison D. Weight influenced by their mothers’ attitudes [6], but mothers may change and adverse event incidence with a low dose oral contracep-tive: two randomized placebo-controlled trials. Contraception 2001; not share their personal OC history.
There are several limitations worth noting. First, the lack [5] Risser WL, Gefter LR, Barratt MS, Risser JMH. Weight change in of difference in demographic characteristics between com- adolescents who used hormonal contraception. J Adolesc Health pleters and noncompleters may be because of the fact that the study noncompleters may not have discontinued their [6] Cromer BA, Smith D, Blair JM, Dwyer J, Brown RT. A prospective study of adolescents who choose among Levonorgestrel implant OCs. Second, the participants’ description of their antici- (Norplant), medroxyprogesterone acetate (Depo-Provera), or the pated side effects may have been influenced by counseling combined oral contraceptive pill as contraception. Pediatrics 1994; they received before completing the questionnaire (either at

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