ACCEPTABILITY OF ULTRA LOW-DOSE ORAL CONTRACEPTIVES CONTAINING 20 µg ETHINYL ESTRADIOL AND 75 µg GESTODENE IN YOUNG FEMALES IN A MULTICENTER CLINICAL STUDY

  • Bojana Pinter Ginekološka klinika Klinični center Šlajmerjeva ul. 3 1000 Ljubljana
  • Alenka Pretnar Darovec Ginekološka klinika Klinični center Šlajmerjeva ul. 3 1000 Ljubljana
  • Ivan Verdenik Ginekološka klinika Klinični center Šlajmerjeva ul. 3 1000 Ljubljana
  • Alojzija Anderle Zasebna ordinacija za ginekologijo in porodništvo Kopališka cesta 7 4240 Radovljica
  • Lara Beseničar Služba za varstvo žena Zdravstveni dom Nova Gorica Rejčeva ul. 4 5000 Nova Gorica
  • Martina Bučar Dispanzer za ženske Zdravstveni dom Novo mesto Kandijska cesta 4 8000 Novo mesto
  • Cvetka Fakin Dispanzer za ženske Zdravstveni dom Trbovlje Rudarska cesta 12 1420 Trbovlje
  • Vilma Kovač Služba za ginekologijo in perinatologijo Splošna bolnišnica Maribor Ljubljanska ul. 5 2000 Maribor
  • Danilo Maurič Dispanzer za ženske Zdravstveni dom dr. Adolfa Drolca Maribor Vošnjakova ul. 2–4 2000 Maribor
  • Dragoslav Mugoša Dispanzer za ženske Zdravstveni dom Sežana Partizanska c. 24 6210 Sežana
  • Marjeta Podlipnik Dispanzer za žene Zdravstveni dom Kranj Gosposvetska ul. 10 4000 Kranj
  • Nives Rožič Vičič Dispanzer za ženske Zdravstveni dom Izola Ul. oktobrske revolucije 11 6310 Izola
Keywords: contraceptive pills, side effects, sex hormones, continuation of use, body weight

Abstract

Background. The acceptability of ultra low-dose oral contraception (OC) among young females after three and six cycles of treatment was assessed.

Methods. In the clinical prospective study, carried out in 10 outpatient clinics in Slovenia, 240 healthy women aged 16– 30 years choosing ultra low-dose OC (20 µg ethinyl estradiol and 75 µg gestodene) were included.

Results. The average age was 20.6 (± 3.5) years. After three cycles (N = 228) there were no changes in body weight or blood pressure; one tenth (9.6%) of women reported irregular bleeding and 3.9% weight gain while other side effects occurred rarely. After three cycles 88.3% of the women initially included continued OC use (5% discontinued the use due to side effects). After six cycles (N = 195) there were no changes in blood pressure; body weight statistically significantly increased for 0.5 kg providing the weight changes during the time were not considered. Fewer women reported side effects (3.6% irregular bleeding, 2.6% weight gain and rarely other side effects). After six cycles 75.0% of the women initially included continued the OC use (7.5% discontinued the use due to the side effects).

Conclusions. The study has shown good clinical acceptability of ultra low-dose OC by young females.

Downloads

Download data is not yet available.

References

Poindexter A. The emerging use of the 20-µg oral contraceptive. Feril Steril 2001; 75: 457–65.

Endrikat J, Duesterberg B, Ruebig A, Gerlinger C, Strowitzki. Comparison of efficacy, cycle control, and tolerability of two low-dose oral contraceptives in a multicenter clinical study. Contraception 1999; 60: 269–74.

Girolami A, Spiezia L, Rossi F, Zanon E. Oral contraceptives and venous thromboembolism: which are the safest preparations available. Clin Appl Thrombosis/Hemostasis 2002; 8: 157–62.

Lech MM, Ostrowska L. Effects of low-dose OCs on weight in women with Central European nutritional habits and lifestyle. Contraception 2002; 65: 159–62.

Endrikat J, Gerlinger C, Cronin M et al. Body weight change during use of a monophasic oral contraceptive containing 20 µg ethinylestradiol and 75 µg gestodene with a comparison of the women who completed versus those who prematurely discontinued intake. Eur J Contracept Reprod Health Care 2001; 6: 199–204.

Lello S, Monterbbianesi M, Guardianelli F, Bianchi C, Simonelli C. Clinical trial of a monophasic estroprogestin oral formulation containing 20 µg ethinyl estradiol and 75 µg gestodene. Gynecol Endocrinol 2001; 15: 265–71.

Endrikat J, Mueller U, Duesterberg B. A twelve-month comparative clinical investigation of two low-dose oral contraceptives containing 20 µg ethinylestradiol/75 µg gestodene and 30 µg ethinylestradiol/75 µg gestodene, with respect to efficacy, cycle control, and tolerance. Contraception 1997; 5: 131–7.

Endrikat J, Cronin M, Gerlinger C, Ruebig A, Schmidt W, Duesterberg B. Double-blind, multicenter comparison of efficacy, cycle control, and tolerability of a 23-day versus a 21-day low-dose oral contraceptive regimen containing 20 µg ethinyl estradiol and 75 µg gestodene. Contraception 2001; 64: 99–105.

Bassol S, Alvarado G, Arreola RG et al. A 13-month multicenter clinical experience of a low-dose monophasic oral contraceptive containing 20 µg ethinylestradiol and 75 µg gestodene in Latin American women. Contraception 2003; 67: 367–72.

Taneepanichskul S, Kriengsinyot R, Jaisamrarn U. A comparison of cycle control, efficacy, and side effects among healthy Thai women between two low-dose oral contraceptives containing 20 µg ethinylestradiol/75 µg gestodene (Meliane) and 30 µg ethinylestradiol/75 µg gestodene (Gynera). Contraception 2002; 66: 407–9.

Serfaty D, Vree ML. A comparison of the cycle control and tolerability of two ultra low-dose oral contraceptives containing 20 µg ethinylestradiol and either 150 µg desogestrel or 75 µg gestodene. Eur J Contracept Reproduct Health Care 1998; 3: 179–89.

Kahn LS, Halbreich U. Oral contraceptives and mood. Expert Opin Pharmacother 2001; 2: 1367–82.

How to Cite
1.
Pinter B, Pretnar Darovec A, Verdenik I, Anderle A, Beseničar L, Bučar M, Fakin C, Kovač V, Maurič D, Mugoša D, Podlipnik M, Rožič Vičič N. ACCEPTABILITY OF ULTRA LOW-DOSE ORAL CONTRACEPTIVES CONTAINING 20 µg ETHINYL ESTRADIOL AND 75 µg GESTODENE IN YOUNG FEMALES IN A MULTICENTER CLINICAL STUDY. TEST ZdravVestn [Internet]. 1 [cited 5Aug.2024];73(6). Available from: http://vestnik-dev.szd.si/index.php/ZdravVest/article/view/2332
Section
Professional Article