Research article summary (published 30 Dec 2008):

Estradiol valerate/dienogest: in oral contraception.

Full Abstract

Estradiol valerate/dienogest is an oral contraceptive for women that combines the natural estrogen estradiol with the 19-nortestosterone derivative dienogest in a four-phasic formulation. Estradiol valerate/dienogest demonstrated contraceptive efficacy in a large (n = 1377), noncomparative, multicentre study in women aged 18-50 years, with 13 pregnancies over 1797.5 women-years of exposure generating an unadjusted Pearl Index (PI) of 0.73 (upper limit of 95% CI 1.24) [primary endpoint]. Six of the pregnancies were attributed to method failure, resulting in an adjusted PI, based on 1786.5 women-years of exposure, of 0.34 (upper limit of 95% CI 0.73). In a double-blind study in 798 women aged 18-50 years, estradiol valerate/dienogest and ethinylestradiol/levonorgestrel demonstrated an acceptable bleeding pattern and level of cycle control, according to several co-primary endpoints. As reported in the UK manufacturer's summary of product characteristics, the unadjusted PI for women aged 18-35 years or 18-50 years in a pooled analysis of clinical studies was 1.01 (upper limit of 95% CI 1.59) and 0.79 (upper limit of 95% CI 1.23). This pooled analysis of three studies excluded those pregnancies occurring within 14 days of the cessation of therapy. Estradiol valerate/dienogest was generally well tolerated in this population, with the nature of adverse events generally similar across the studies and between estradiol valerate/dienogest and ethinylestradiol/levonorgestrel.

Author information

Author/s: Hoy, Sheridan M (SM); Scott, Lesley J (LJ);

Affiliation: Wolters Kluwer Health/Adis, 41 Centorian Drive, Mairangi Bay, North Shore 0754, Auckland, New Zealand. demail(-atsign-)adis.co.nz

Journal and publication information

Publication Type: Journal Article; Review

Journal: Drugs (Drugs), published in New Zealand. (Language: eng)

Reference: 2009-; vol 69 (issue 12) : pp 1635-46

Dates: Created 2009/08/14; Completed 2009/10/30;

PMID: 19678714, status: MEDLINE (last retrieval date: 10/30/2009, IMS Date: )

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Adolescent Adult Chemistry, Pharmaceutical Contraceptives, Oral - administration & dosage; adverse effects Drug Combinations Estradiol - administration & dosage; adverse effects; analogs & derivatives

Female Humans Middle Aged Nandrolone - administration & dosage; adverse effects; analogs & derivatives Pregnancy Young Adult

Associated Chemicals: Contraceptives, Oral (0) ; Drug Combinations (0) ; Nandrolone (434-22-0) ; Estradiol (50-28-2) ; dienogest (65928-58-7) ; estradiol valerate (979-32-8)

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