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Common name
Klimodien (dienogest and estradiol valerat)
Synonyms: Klimodien
Description
Klimodien is a continuous combined hormone replacement therapy (HRT) for oral use in women with an intact uterus. The product consists of a fixed combination of two active ingredients, estradiol valerate 2 mg and dienogest 2 mg. For The Netherlands, dienogest, a derivative of nortestosterone, is a new progestagen. Dienogest is the active ingredient of two oral combined contraceptives that are marketed only in Germany in 1991 and 1995, respectively Certostat (ethinyl estradiol 50 mg + dienogest 2 mg) and its successor Valette (30 mg ethinyl estradiol + dienogest 2 mg). The rationale for the development of a new progestagen like dienogest was to have a progestagen with strong anti-estrogenic and progestational effect and no androgenic effect.
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Active Ingredients:
Dienogest and estradiol valerat
Therapeutic actions:
The estrogenic component, estradiol valerate, is a prodrug of estradiol. The esterification leads to a greater bioavailability of estradiol. Estradiol valerate as monotherapy is since long registered for estrogen replacement therapy under the name of Progynova and is also a component of a number of combined HRT is.
What is it used for?:
(Indications:)
Hormone replacement therapy for estrogen deficiency symptoms in women who are at least one year postmenopausal and who still have their uterus. Additional claims proposed for inclusion under Pharmacodynamic effects of the SPC included a positive effect on postmenopausal sleeping disorders and a statement on direct action of estrogens on the vasculature, that is not diminished by the addition of dienogest. These claims could not be allowed. The dose recommendation is one tablet daily.
Side effects:
The most frequently (3.2%) reported adverse events, which by the investigators were assessed as related to Klimodien included (in order of their frequency): breakthrough bleeding/metrorrhagia (22.9%), mastalgia (13.2%), headache (5.5%), hypertension/aggravated hypertension (3.7%), thrush (2.6%), migraine (2.3%), increase in endometrial thickness (2.2%) and weight increase (2.1%). In the comparative study versus Klimodien 2/3 and Kliogest, the most frequently (?1%) reported adverse events with possible relationship to study medication did not indicate clear differences between treatment groups.
Interactions:
In studies in which different amounts of estradiol and dienogest were co-administered dienogest did not influence the pharmacokinetics of estradiol. Nifedipine was administered without dienogest and after treatment for 21 days with Certostat (30 mg ethinyl estradiol and 2 mg dienogest). No differences were found between the two treatments with nifedipine, indicating that dienogest does not affect CYP 3A4 metabolic system. This is in conformity with pre-clinical studies
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