Characterization of ovulation inhibition of a new vaginal delivery system containing trimegestone - an open-label, single-centre study in healthy females of childbearing potential - Ovulation inhibition study with trimegestone

Evestra GmbH0 sites100 target enrollmentApril 10, 2018

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Investigation of ovulation inhibition for indication of contraception
Sponsor: Evestra GmbH
Enrollment: 100
Status: Active, not recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

April 10, 2018

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

Evestra GmbH

•1\. written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in the clinical trial
•2\. sex: female
•3\. age: 18 years to 38 years inclusive
•4\. body\-mass index (BMI): \>\= 18 kg/m² and \= 30\.0 kg/m²
•5\. good state of health
•6\. non\-smoker or ex\-smoker for at least 3 months aged \>30 years or moderate smoker (10 cigarettes or 2 cigars or 2 pipes per day) aged \= 30 years only; questioned at screening examination
•7\. both ovaries visible upon transvaginal ultrasonography; observed at screening examination
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•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 (e.g. severe renal insufficiency or acute renal failure) or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient
•3\. existing diseases or pathological findings of genital organs, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
•4\. history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
•5\. known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations
•6\. subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
•7\. systolic blood pressure \< 80 or \>\= 140 mmHg
•8\. diastolic blood pressure \< 50 or \>\= 90 mmHg
•9\. pulse rate \< 50 bpm or \> 90 bpm
•10\. laboratory values out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator