Climodien® (estradiol valerate 2 mg plus dienogest 2 mg) is safe and effective in the treatment of postmenopausal complaints

Gräser, T; Römer, Thomas; Wiedey, K. D.; Janaud, A

doi:10.1080/713605132

Cited by 3 publications

(1 citation statement)

References 26 publications

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“…La tolérance de Climodiène ® sur le plan des saignements s'est avérée bonne [12], avec 67 et 85 % d'aménorrhées respectivement à trois et 12 mois de traitement. Climodiène ® s'est révélé efficace sur les plaintes climatériques et bien toléré dans une étude de phase III [13] sur 1501 femmes traitées pendant un an.…”

Section: Discussionunclassified

Acceptabilité par les patientes d'un THS combiné continu versus cyclique : une étude clinique randomisée multicentrique française

Drapier-Faure

Azoulay

Abramovici³

2005

Gynécologie Obstétrique & Fertilité

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Section: Discussionunclassified

Acceptabilité par les patientes d'un THS combiné continu versus cyclique : une étude clinique randomisée multicentrique française

Drapier-Faure

Azoulay

Abramovici³

2005

Gynécologie Obstétrique & Fertilité

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Endometrial safety of an oral contraceptive containing estradiol valerate and dienogest

Bitzer

Parke

Roemer³

et al. 2011

IJWH

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Background:The purpose of this study was to investigate the endometrial safety of an oral contraceptive containing estradiol valerate/dienogest (E2V/DNG) administered as an estrogen step-down and progestogen step-up regimen in women of reproductive age (18–50 years), using histological assessment of endometrial biopsy samples.Methods:Endometrial biopsies were taken in a subset of healthy women who took part in a multicenter, open-label, noncomparative study assessing the contraceptive efficacy and safety of an E2V/DNG oral contraceptive. In each 28-day cycle, women received E2V 3 mg on days 1–2, E2V 2 mg/DNG 2 mg on days 3–7, E2V 2 mg/DNG 3 mg on days 8–24, E2V 1 mg on days 25–26, and placebo on days 27–28. Women underwent endometrial biopsy between days 12 and 19 of the cycle, both at screening and at cycle 20 (or at the final examination).Results:Of the 283 women who underwent an endometrial biopsy at screening, 218 underwent a follow-up biopsy at cycle 20. At screening, abnormal biopsy results, both classified as “simple hyperplasia without atypia”, were seen in two women, who were withdrawn from the trial. At cycle 20, there were no abnormal findings of endometrial hyperplasia or malignancy, and 80.9% of women had atrophic, inactive, or secretory endometrium.Conclusion:After 20 cycles of treatment, an oral contraceptive containing E2V and DNG is safe and effective to transform the endometrium into a secretory/inactive or atrophic status, and exhibits no deleterious effects on endometrial histology in women aged 18–50 years.

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Estradiol Valerate/Dienogest

Wellington¹,

Perry²

2002

Drugs

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Estradiol valerate 2mg/dienogest 2mg is an oral estrogen/ progestogen formulation that has been approved throughout the European Union for the treatment of climacteric symptoms in postmenopausal women. Dienogest is a progestogen that combines the properties of both progesterone and 19-nortestosterone derivatives. It has moderate affinity for the progesterone receptor, significant antiproliferative and antiandrogenic activity, and produces secretory transformation of the endometrium. Estradiol valerate is an esterified form of natural 17beta-estradiol, the most potent endogenous human ovarian estrogen, and is hydrolysed to estradiol soon after oral administration. Results from a randomised, double-blind, multicentre trial showed that oral estradiol valerate 2mg/dienogest 2mg and estradiol valerate 2mg/dienogest 3mg once daily for 1 year were each as effective as estradiol 2mg/estriol 1mg/norethisterone acetate 1mg in the treatment of climacteric symptoms in 581 postmenopausal women; reductions from baseline in Kupperman Index scores were 78.5, 74.5 and 75.0%, respectively. The number of days without any type of bleeding was lowest in patients treated with estradiol valerate 2mg/dienogest 2mg (8.7 days), and highest in the estradiol valerate 2mg/ dienogest 3mg group (12.1 days). During the twelfth month of treatment with estradiol valerate 2mg/dienogest 2mg, the percentage of patients who reported bleeding was 14.5%. Endometrial biopsy results were similar in patients treated with estradiol valerate 2mg/dienogest 2mg, estradiol valerate 2mg/dienogest 3mg or estradiol 2mg/estriol 1mg/norethisterone acetate 1mg once daily for 1 year; 90.8, 87.4 and 87.5% of samples, respectively, contained atrophic material. Proliferative material was found in 4.2, 2.5 and 4.4% of the biopsies, respectively; there was no incidence of hyperplasia in any of the treatment groups. A noncomparative multicentre study in 1501 postmenopausal women demonstrated that adverse events associated with estradiol valerate 2mg/dienogest 2mg once daily for 48 weeks included breakthrough bleeding, mastalgia, headache, abdominal pain, hypertension, thrush, migraine, weight gain, increase in endometrial thickness and metrorrhagia.

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Climodien® (estradiol valerate 2 mg plus dienogest 2 mg) is safe and effective in the treatment of postmenopausal complaints

Abstract: Continuous combined estrogen-progestin therapy with Climodien is effective, safe and well tolerated in postmenopausal women, with a profile and incidence of adverse events consistent with those of existing HRT preparations.

Cited by 3 publications

References 26 publications

Acceptabilité par les patientes d'un THS combiné continu versus cyclique : une étude clinique randomisée multicentrique française

Acceptabilité par les patientes d'un THS combiné continu versus cyclique : une étude clinique randomisée multicentrique française

Endometrial safety of an oral contraceptive containing estradiol valerate and dienogest

Estradiol Valerate/Dienogest

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