Assessment of therapeutical equivalence of a newly developed vaginal tablet containing 10 µg of estradiol in comparison with a marketed reference product (Vagifem®) – a double-blind, double-dummy, multiple dose, parallel-group, placebo- and active-controlled trial with additional characterisation of systemic exposure in postmenopausal female volunteers suffering from vaginal atrophy - Therapeutical equivalence of estradiol vaginal tablets in postmenopausal women with vaginal atrophy

Helm AG0 sites50 target enrollmentApril 13, 2017

Overview

No summary available.

Registry

who.int

Start Date

April 13, 2017

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Helm AG

•1\. Age: 18 years or older
•2\. Good state of health commensurate with age
•3\. Postmenopausal state defined as follows:
•\- last spontaneous menstruation at least 1 year prior to the study and FSH (plasma) \>\= 40 IU/l, estradiol (serum) \<\= 20 pg/ml, or
•\- bilateral ovariectomy with or without hysterectomy at least 3 months prior to individual enrolment
•4\. Maturation value \= 50 %
•5\. Vaginal pH \> 5\.0
•6\. Investigator’s assessment of vaginal health: visually assessed signs of vaginal atrophy (a thinned vaginal mucosa or a mucosa with flattening of folds; a dry, fragile, or pale vaginal mucosa; the presence of petechiae or any other alteration that the investigator considers indicative of vaginal atrophy)
•7\. At least one urogenital symptom self\-assessed by the subjects (vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, dysuria, dyspareunia, vaginal bleeding associated with sexual activity, recurrent vaginal infections, hyperactive bladder with urge incontinence or stress incontinence
•8\. Non\-smoker or ex\-smoker for at least 6 months

•Safety concerns
•1\. Existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
•2\. Existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient
•3\. History of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
•4\. Known allergic reactions/hypersensitivity to the active ingredient used or to constituents of the pharmaceutical preparations
•5\. Subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
•6\. Systolic blood pressure \> 145 mmHg
•7\. Diastolic blood pressure \>90 mmHg
•8\. Pulse rate \< 50 bpm or \> 100 bpm
•9\. Any laboratory value outside of normal and judged by investigator as relevant for participation under safety considerations