EUCTR2016-000115-32-DE
Active, not recruiting
Phase 1
Characterization of ovulation inhibition of a new vaginal delivery system (EVE 112, Evestra/Germany) containing etonogestrel and ethinylestradiol – an open label, single centre, comparative, parallel-group study in healthy females of childbearing potential - Ovulation inhibition study with etonogestrel and ethinylestradiol
Evestra GmbH0 sitesJanuary 27, 2016
DrugsNuvaRing®
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Evestra GmbH
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Sex: female
- •2\.Age: \= 18 years and \= 35 years
- •3\.Body\-mass index (BMI): \= 18\.5 kg/m² and \= 30\.0 kg/m²
- •4\.Good state of health
- •5\.Non\-smoker, ex\-smoker for at least 3 months or moderate smoker (10 cigarettes or 2 cigars or 2 pipes per day) aged \=30 years only; questioned at screening examination
- •6\.Both ovaries visible upon transvaginal ultrasonography; observed at screening examination
- •7\.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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •1\.Existing cardiac and/or haematological diseases or pathological findings which might interfere with the efficacy, safety and/or tolerability of the active ingredients
- •2\.Existing hepatic and/or renal diseases or pathological findings which might interfere with the efficacy, the safety and/or tolerability of the active ingredients
- •3\.Existing diseases or pathological findings of genital organs which might interfere with efficacy, safety and/or tolerability of the IMPs
- •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 \> 140 mmHg
- •8\.Diastolic blood pressure \> 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
Outcomes
Primary Outcomes
Not specified
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