Characterization of ovulation inhibition of a new vaginal ring (EVE 112, Evestra/Germany) containing the hormones etonogestrel and ethinylestradiol – an open label, single centre, comparative, parallel-group study in healthy females of childbearing potential

Phase 1

• Conditions: Investigation of ovulation inhibition for indication of contraception.; MedDRA version: 19.0Level: LLTClassification code 10073728Term: Hormonal contraceptionSystem Organ Class: 100000004865; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2016-000115-32-DE
• Lead Sponsor: Evestra GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-27
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

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
F.1.2.1 Number of subjects for this age range 88
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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
11.Positive anti-HIV-test (if positive to be verified by western blot), HBs-AG-test (if positive to be verified by test for HBc-IgM) or anti-HCV-test
12.Presence or history of venous or arterial thrombosis (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction or prodromal conditions (e.g. angina pectoris, transient ischaemic attack)), cerebrovascular accident, inborn or acquired predisposition for venous or arterial thrombosis
13.Anamnestic hints for increased risk of thrombosis events in family history
14.Known hereditary or acquired predisposition for venous thromboembolism, such as APC resistance, antithrombin-III-deficiency, protein-C or –S-deficiency
15.Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant)).
16.Known medical factors coming along with an increased risk of venous and/or arterial thromboembolism as e.g. systemic lupus erythematosus, haemolytic uraemic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), sickle cell disease, and dyslipoproteinaemia
17.Presence or history of liver tumours (benign or malignant) or known or suspected sex-hormone influenced malignancies of the genital organs or breasts
18.Severe lipopathy
19.Diabetes mellitus
20.Unclarified vaginal bleeding
21.Existing cervicitis, vaginitis or bleeding cervical erosions
22.Diagnosis of a cervical smear: Bethesda classification AGC, LISL or HSIL (corresponds to Papanicolaou class III or higher)
23.Prolapse of uterine cervix, cystocele and/or rectocele
24.Severe or chronic constipation
25.History of migraine with focal neurological symptoms
26.Acute or chronic diseases which may interfere with the aims of the clinical trial
27.History of or current drug or alcohol dependence
28.Regular intake of alcoholic food or beverages of = 20 g pure alcohol per day
29.Blood donation or other blood loss of more than 400 mL within the last 2 months prior to individual start of pre-treatment cycle of the subject
30.Participation in a clinical trial during the last 2 months prior to individual start of pre-treatment cycle of the subject
31.Regular treatment with any systemically available medication during the last 2 weeks prior to start of pre-treatment cycle which might interfere with pharmacodynamics or safety of the IM

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified