NDLI: Estradiol valerate/dienogest: a novel combined oral contraceptive.

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Estradiol valerate/dienogest: a novel combined oral contraceptive.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Borgelt, Laura M. Martell, Chad W.
Description	Country affiliation: United States Author Affiliation: Borgelt LM ( Department of Clinical Pharmacy and Family Medicine, Anschutz Medical Campus, University of Colorado, Aurora, CO, USA.)
Abstract	BACKGROUND: Estradiol valerate/dienogest (E2V/DNG) is a combined oral contraceptive (COC) with 2 new hormonal entities and a unique 4-phasic dosing regimen indicated for women to prevent pregnancy. OBJECTIVE: The purpose of this article is to review the pharmacology, pharmacokinetics, clinical efficacy, tolerability, and cost of E2V/DNG. METHODS: MEDLINE (1966-June 2011) and EMBASE (1966-June 2011) were searched for original research and review articles published in the English language using the terms Natazia or Qlaira or estradiol valerate and dienogest. The reference lists of identified articles were reviewed for additional pertinent publications. Abstracts from the 2005 to 2011 American Society of Reproductive Medicine and American College of Obstetricians and Gynecologists meetings were searched using the same terms. RESULTS: The search provided 56 articles that addressed the pharmacology, pharmacokinetics, pharmacodynamics, clinical efficacy, and tolerability of E2V/DNG in women of reproductive age. Articles reporting efficacy or tolerability in the setting of menopause were excluded. The initial efficacy of E2V/DNG on ovulation inhibition was investigated in 2 prospective, randomized, open-label, Phase II dose-finding studies. The dose that was approved by the Food and Drug Administration resulted in 3.13% of women ovulating in the second cycle of treatment (90% CI, 0.2%-6.05%). Rate of pregnancy prevention with this agent was reported with a Pearl Index ranging from 0.73 to 1.27 (unadjusted) to 0.34 to 0.72 (adjusted for method failure only). The mean duration of withdrawal bleeding was 4.3 days (range, 4.0-4.6 days) among 2266 women receiving 13 treatment cycles. Adverse events reported in >1% of patients included abdominal pain, acne, breast pain, dysmenorrhea, emotional lability, headache, nausea, and weight increase. CONCLUSIONS: Estradiol valerate/dienogest is a new contraceptive formulation. It offers efficacy, tolerability, and an acceptable safety profile with a potentially better bleeding pattern than levonorgestrel-containing COCs. This COC may be especially useful for older women of reproductive age who are adherent to therapy and looking for shorter and/or lighter menstrual cycles. Studies will need to be performed to determine whether clinically significant differences in outcomes exist among E2V/DNG and other available COCs.
File Format	HTM / HTML
ISSN	01492918
Issue Number	1
Volume Number	34
e-ISSN	1879114X
Journal	Clinical Therapeutics
Language	English
Publisher	Elsevier
Publisher Date	2012-01-01
Publisher Place	United States
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Contraceptives, Oral, Combined Therapeutic Use Contraceptives, Oral, Hormonal Estradiol Analogs & Derivatives Nandrolone Administration, Oral Animals Administration & Dosage Adverse Effects Economics Pharmacokinetics Drug Administration Schedule Drug Costs Female Humans Pregnancy Treatment Outcome Journal Article Review
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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Estradiol valerate/dienogest: a novel combined oral contraceptive.

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Estradiol valerate/dienogest: a novel combined oral contraceptive.