Trial Profile

Open-label, Randomized, Cross-over Study to Investigate the Bioequivalence of Estradiol Valerate (EV), Dienogest (DNG) and Levomefolate Calcium After Single Oral Administration of a Tablet Formulation Containing 2 mg Estradiol Valerate and 3 mg Dienogest Without and With 0.451 mg Levomefolate Calcium and a Tablet Formulation Containing 0.451 mg Levomefolate Calcium in 42 Healthy Postmenopausal Women.

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 18 Sep 2021

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At a glance

Drugs Estradiol valerate/dienogest; Estradiol valerate/dienogest/levomefolic acid; Levomefolic acid
Indications Menopausal syndrome
Focus Pharmacokinetics

01 Aug 2016 Biomarkers information updated
14 Apr 2010 Actual patient number (60) added as reported by ClinicalTrials.gov.
14 Jan 2010 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.

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