Characterization of ovulation inhibition of a new vaginal ring containing the hormone trimegestone - an open-label, single-centre study in healthy females of childbearing potential

Phase 1

• Conditions: Investigation of ovulation inhibition for indication of contraception; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2017-004664-36-DE
• Lead Sponsor: Evestra GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-10
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

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
F.1.2.1 Number of subjects for this age range 100
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 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
11. ASAT > 20 % ULN, ALAT > 10 % ULN, bilirubin > 20% ULN (except in case of existing Morbus Gilbert-Meulengracht deduced from anamnesis/medical history)
12. 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
13. 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
14. anamnestic hints for increased risk of thrombosis events in family history
15. known hereditary or acquired predisposition for venous thromboembolism, such as APC resistance, antithrombin-III-deficiency, protein-C or -S-deficiency
16. known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant).
17. 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
18. Presence or history of liver tumours (benign or malignant) or known or suspected malignancies of the genital organs or breasts (mammae), regardless of the hormone status
19. Presence or history of leiomyoma, endometriosis, or endometrial hyperplasia
20. Known severe lipopathy
21. Fibrocystic mastopathy
22. Diabetes mellitus
23. Hereditary angioedema
24. Unclarified vaginal bleeding
25. Existing cervicitis, vaginitis or bleeding cervical erosions at day of randomisation
26. Diagnosis of latest PAP smear: findings classified in a group higher than PAP I
27. Prolapse of uterine cervix, cystocele and/or rectocele
28. History of severe or chronic constipation
29. Presence or history of migraine as defined by criteria of International Headache Society
30. Acute or chronic diseases, which may interfere with the aims of the clinical trial
31. history of or current drug or alcohol dependence
32. regular intake of alcoholic food or beverages of > 20 units alcohol

Study & Design

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