The use of an oral contraceptive containing ethinylestradiol and drospirenone in an extended regimen over 126 days.

Abstract

OBJECTIVE:

To assess the bleeding profile, acceptance and safety of an extended 126-day regimen of the oral contraceptive Yasmin [30 microg ethinylestradiol (EE) and 3 mg drospirenone (DRSP)].

METHODS:

Using daily diaries, 177 women recorded bleeding events throughout the 126-day cycle. At end of treatment, the women completed questionnaires reflecting their satisfaction with the extended regimen. A subset of 30 women underwent endometrial histology sampling after completion of the extended regimen.

RESULTS:

Of 177 women assigned to the extended regimen, 80.8% completed the extended 126-day regimen. Approximately 40% of the women reported complete absence of bleeding, while in 60% a shift towards less intense bleeding was observed. The first onset of bleeding occurred after a median of 99.0 days into the extended cycle. The acceptance of the extended regimen was high, with 68.4% of the women expressing satisfaction. The general safety profile with the extended use was comparable to that seen with the conventional 21+7-day regimen. All endometrial biopsies with sufficient material for analysis were normal and supported the endometrial safety of the extended regimen.

CONCLUSION:

This study showed that the continuous use of a 30-microg EE and 3-mg DRSP formulation over 126 days was safe, efficacious, well accepted by the users and resulted in a considerable reduction of bleeding.

• Authors: Jean-Michel Foidart, Patricia J Sulak, Ilka Schellschmidt, Doris Zimmermann, Yasmin Extended Regimen Study Group
• Journal: Contraception (Contraception) Vol. 73 Issue 1 Pg. 34-40 (Jan 2006) ISSN: 0010-7824 [Print] United States
• PMID: 16371292 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)

Chemical References

• Androstenes
• Contraceptives, Oral
• Ethinyl Estradiol
• drospirenone

Topics

• Adult
• Androstenes (administration & dosage)
• Contraceptives, Oral (administration & dosage, adverse effects)
• Ethinyl Estradiol (administration & dosage)
• Female
• Humans
• Menstrual Cycle
• Patient Satisfaction
• Prospective Studies
• Time Factors
• Uterine Hemorrhage (epidemiology)