Bleeding pattern and cycle control with an estradiol-based oral contraceptive: a seven-cycle, randomized comparative trial of estradiol valerate/dienogest and ethinyl estradiol/levonorgestrel.

Abstract

BACKGROUND:

This study compared the bleeding pattern, cycle control and safety of an oral contraceptive (OC) comprising estradiol valerate/dienogest (E2V/DNG; administered using a dynamic dosing regimen) with a monophasic OC containing ethinyl estradiol 20 mcg/levonorgestrel 100 mcg (EE/LNG). E2V releases estradiol (E2), which is identical to endogenously produced 17beta-estradiol.

STUDY DESIGN:

This was a randomized, multicenter, double-blind, double-dummy trial lasting seven cycles in healthy women aged 18-50 years.

RESULTS:

Overall, 798 women were randomized and received allocated treatment (399 per group). There were significantly fewer bleeding/spotting days reported by women who received E2V/DNG than those who received EE/LNG [17.3+/-10.4 vs. 21.5+/-8.6, respectively, p<.0001, Reference Period 1 (Days 1-90); and 13.4+/-9.vs. 15.9+/-7.1, respectively, p<.0001, Reference Period 2 (Days 91-180)]. Through Cycles 1-7, the occurrence of scheduled withdrawal bleeding per cycle was 77.7-83.2% with E2V/DNG and 89.5-93.8% with EE/LNG (p<.0001 per cycle). The duration and intensity of scheduled withdrawal bleeding were reduced with E2V/DNG vs. EE/LNG. The incidence of intracyclic bleeding was similar with E2V/DNG (10.5%-18.6%) and EE/LNG (9.9%-17.1%) (p>.05 per cycle). No unintended pregnancies occurred with E2V/DNG, but there was one unintended pregnancy with EE/LNG. Adverse drug reactions occurred in 10.0% and 8.5% of women taking E2V/DNG and EE/LNG, respectively. Overall, 79.4% of women were satisfied with E2V/DNG and 79.9% with EE/LNG.

CONCLUSIONS:

A novel OC composed of E2V/DNG is associated with an acceptable bleeding profile that is comparable to that of an EE-containing OC.

• Authors: Hans-Joachim Ahrendt, Dagmar Makalová, Susanne Parke, Uwe Mellinger, Diana Mansour
• Journal: Contraception (Contraception) Vol. 80 Issue 5 Pg. 436-44 (Nov 2009) ISSN: 1879-0518 [Electronic] United States
• PMID: 19835717 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Contraceptives, Oral, Combined
• Drug Combinations
• estradiol valerate-dienogest
• ethinyl estradiol, levonorgestrel drug combination
• Ethinyl Estradiol
• Estradiol
• Levonorgestrel
• Nandrolone

Topics

• Adolescent
• Adult
• Contraceptives, Oral, Combined (adverse effects, pharmacology)
• Double-Blind Method
• Drug Combinations
• Estradiol (adverse effects, analogs & derivatives, pharmacology)
• Ethinyl Estradiol (adverse effects, pharmacology)
• Female
• Humans
• Levonorgestrel (adverse effects, pharmacology)
• Menstrual Cycle (drug effects)
• Menstruation Disturbances (chemically induced)
• Metrorrhagia (chemically induced)
• Middle Aged
• Nandrolone (adverse effects, analogs & derivatives, pharmacology)
• Patient Satisfaction (statistics & numerical data)
• Treatment Outcome
• Young Adult