Cycle control, quality of life and acne with two low-dose oral contraceptives containing 20 μg ethinylestradiol

doi:10.1016/j.contraception.2003.12.017

Contraception

Volume 69, Issue 6, June 2004, Pages 469-476

https://doi.org/10.1016/j.contraception.2003.12.017 Get rights and content

Abstract

Objectives

Poor cycle control and tolerability can be reasons for irregular pill intake. This study compared the tolerability of two low-dose oral contraceptives and their effect on cycle control.

Methods

In this open, group-comparative, randomized multicenter trial in Germany and the Netherlands, women received either 20 μg ethinylestradiol plus 150 μg desogestrel (20EE/DSG; n = 500) or 20 μg ethinylestradiol plus 100 μg levonorgestrel (20EE/LNG; n = 498) for six treatment cycles. Cycle control, dysmenorrhea and premenstrual syndrome (PMS) were assessed using diary cards. Tolerability was assessed using the self-administered questionnaires Psychological General Well-Being Index (PGWBI) and the Profile of Mood States (POMS). Acne was assessed by objective (acne counts) and subjective (no, moderate, mild, severe) acne scoring of the facial area at baseline and treatment cycles 1, 3 and 6.

Results

A total of 404 (78.1%) and 384 (75.3%) women in the 20EE/DSG and 20EE/LNG groups, respectively, completed the trial. The occurrence rate of irregular bleeding and spotting was statistically significantly higher with 20EE/LNG than with 20EE/DSG (0.18 vs. 0.13; p < 0.05). The mean number of bleeding-spotting days per cycle was statistically significantly higher with 20EE/LNG than with 20EE/DSG (0.63 vs. 0.48; p < 0.05). Early withdrawal bleeding was more frequent with 20EE/LNG (0.15 vs. 0.08; p < 0.005), whereas continued withdrawal bleeding was more frequent with 20EE/DSG (0.32 vs. 0.45; p < 0.001); absence of withdrawal bleeding was comparable (0.06 vs. 0.04, respectively). Thirteen subjects in the 20EE/LNG group and three in the 20EE/DSG group discontinued due to unacceptable bleeding (p < 0.05). Dysmenorrhea and PMS decreased comparably in both groups. There were no differences between groups for the mean total scores of PGWBI or POMS at all time-points. Fewer acne lesions were counted with 20EE/DSG vs. 20EE/LNG after six cycles (p < 0.05). The subjective acne scores supported this finding.

Conclusions

20EE/DSG provided better cycle control than 20EE/LNG with less treatment discontinuation due to unacceptable bleeding. There were no apparent differences between the two groups regarding tolerability and quality of life. There was less acne with 20EE/DSG.

Introduction

Since their introduction in the 1960s, oral contraceptives (OCs) have undergone significant changes, from reduction of the estrogen content to modification of the progestogen component. These changes have all been implemented to reduce unwanted side effects associated with the high dosages of the earlier pills [1], [2], [3], [4], [5], [6], [7], [8], [9]. In the 1980s, the estrogen dose was reduced to as little as 30 μg per pill, which still provided good cycle control with little spotting or breakthrough bleeding and high efficacy. Recently, several 20 μg ethinylestradiol-containing OCs have been developed, which also claim good cycle control and efficacy comparable to other higher-dosed pills due to the high selectivity of modern progestogens [10], allowing reduction of ethinylestradiol dose without loss of efficacy and cycle control. In the current trend for women to use less hormones, these low-dose pills suit their needs. Poor cycle control and low tolerability can be a reason for low pill compliance. Ethinylestradiol is the main component of the combined OC, regulating cycle control and also inducing (subjective) side effects [11], [12]. These symptoms can also affect a woman's self-perception and her quality of life. Data on quality of life in young healthy pill users is very limited. This study was performed to compare two different low-dose combined OCs containing 20 μg ethinylestradiol and either desogestrel or levonorgestrel on their effect on cycle control and quality of life. It is thought that desogestrel, having a significantly stronger affinity for the progestogen receptor and a lower affinity for the androgen receptor than levonorgestrel [10], would have a better effect on cycle control, quality of life and acne.

Section snippets

Methods

This was an open-label, randomized, controlled, multicenter clinical trial performed in 50 general practitioner and gynecological practices in Germany and the Netherlands. Eligible participants were women between 18 and 45 years of age, in good physical and mental condition, sexually active, with a body mass index between 18 and 29 kg/m². Women could not participate if their menstrual cycle was shorter than 24 days or longer than 35 days, if they were older than 35 years and smoking, if they

Demographics

A total of 1027 women were enrolled and randomized to treatment (517 women received 20EE/DSG, 510 received 20EE/LNG). Of these, 404 (78.1%) and 384 (75.3%) completed the trial, respectively. Mean age was 28.2 years (range 17–45). There was no clinically significant change in blood pressure or body weight. In both groups there were more pill switchers than pill starters. Pill compliance was high in both groups (>98%) and mean follow-up time was a little over five cycles. More demographic details

Discussion and conclusion

To our knowledge, this is the first randomized clinical trial in which two low-dose combined OCs containing 20 μg ethinylestradiol were compared.

A better cycle control was achieved with 20EE/DSG than with 20EE/LNG. Irregular bleeding and spotting occurred statistically significantly more in the 20EE/LNG group, the difference being caused rather by spotting than by irregular bleeding. The results from this study support earlier findings that 20EE/DSG provides good cycle control [15]. As stated

Acknowledgments

This study was kindly sponsored by NV Organon, Oss, the Netherlands. The authors wish to thank the following persons for their contribution to this study: Germany: Sylvia Zuckschwerdt, Ulrich-J. Koch, Viola Glanz, Barbara Börner, Sylvia Gramatte, Berlin; Bianca Opelka, Oranienburg; Ralf Bensch, Wittenburg; Roswitha Hellmich, Ursula Schlenk, Dresden; Victoria Piesold, Erfurt; Laslo Koos, Barbara Doll, Kurt Stahmer, Hamburg; Robert Hoene, Ahrensburg; Gabriele Simko-Leonhard, Wiesbaden; Sybille

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Original research articleCycle control, quality of life and acne with two low-dose oral contraceptives containing 20 μg ethinylestradiol

Abstract

Objectives

Methods

Results

Conclusions

Introduction

Section snippets

Methods

Demographics

Discussion and conclusion

Acknowledgments

Contraception

Am J Obstet Gynecol

Lancet

Contraception

Contraception

Contraception

Contraception

Hormonal content and potency of oral contraceptives and breast cancer risk among young women

Br J Cancer

Oral contraceptives and myocardial infarction

Br J Fam Plann

Original research article
Cycle control, quality of life and acne with two low-dose oral contraceptives containing 20 μg ethinylestradiol