Bleeding pattern and cycle control of a low-dose transdermal contraceptive patch compared with a combined oral contraceptive: a randomized study

• Published in: Contraception (Stoneham) 2015-02, Vol.91 (2), p.113-120
• Main Authors: Merz, M, Kroll, R, Lynen, R, Bangerter, K
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Amenorrhea - chemically induced; Bleeding pattern; Contraceptive Agents, Female - administration & dosage; Contraceptive Agents, Female - adverse effects; Contraceptive patch; Contraceptives, Oral, Combined - adverse effects; Cycle control; Double-Blind Method; Drug Combinations; Estrogens - administration & dosage; Estrogens - adverse effects; Ethinyl Estradiol - administration & dosage; Ethinyl Estradiol - adverse effects; Female; Female contraception; Humans; Levonorgestrel - administration & dosage; Levonorgestrel - adverse effects; Menorrhagia - chemically induced; Menstrual Cycle - drug effects; Metrorrhagia - chemically induced; Norpregnenes - administration & dosage; Norpregnenes - adverse effects; Obstetrics and Gynecology; Patient Dropouts; Progestins - administration & dosage; Progestins - adverse effects; Transdermal; Transdermal Patch - adverse effects; United States; Young Adult
• ISSN: 0010-7824; 1879-0518
• DOI: 10.1016/j.contraception.2014.10.004

Abstract Objective(s) The aim of this study was to investigate the bleeding pattern and cycle control of a contraceptive patch containing 0.55 mg ethinyl estradiol (EE) and 2.1 mg gestodene (GSD) compared with a combined oral contraceptive (COC) containing 0.02 mg EE and 0.1 mg levonorgestrel (LNG). Study design In this phase III, randomized, controlled, double-blind, double-dummy, multicenter trial, healthy women aged 18–45 years (smokers aged 18–35 years) received either the EE/GSD patch and a placebo tablet ( n = 171), or a placebo patch and the COC ( n = 175) for seven 28-day cycles. Bleeding control was assessed in two 90-day reference periods. Results Mean number of bleeding/spotting days was comparable across treatment groups in both reference periods (p>.05). Mean number of bleeding/spotting episodes was also comparable in reference period 1; however, there were fewer bleeding/spotting episodes for COC in reference period 2 (3.4 versus 3.1; p=.01). Mean length of bleeding/spotting episodes was comparable across treatment groups for both reference periods (p>.05). Withdrawal bleeding occurred consistently in both groups over the entire treatment period, but its absence was more common in the COC group in cycles 4 and 6 of reference period 2 (p