Status:
COMPLETED
Estriol and Trimegestone Dose-response Trial With Single Dose Application of Vaginal Rings
Lead Sponsor:
Galeno Desenvolvimento de Pesquisas Clínicas
Collaborating Sponsors:
SocraTec R&D GmbH
Conditions:
Pregnancy
Eligibility:
FEMALE
18-35 years
Phase:
PHASE1
Brief Summary
This clinical trial is performed as proof of pharmacological action investigation by demonstration of ovulation inhibition (dose-response study) under treatment with three Test vaginal rings releasing...
Detailed Description
The IMPs, releasing either 0.400 mg E3 and 0.06 mg TMG, or 0.300 mg E3 and 0.12 mg TMG, or 0.200 mg E3 and 0.18 mg TMG per 24 h, will be applied intravaginally and remain in the vagina for the subsequ...
Eligibility Criteria
Inclusion
- Under treatment with a commercially available combined oral contraceptive containing 30 µg ethinylestradiol (EE) and 150 µg levonorgestrel (LVN) for the last 3 months prior to enrolment
- Body-mass index (BMI): ≥ 18.5 kg/m² and ≤ 30.0 kg/m²
- Good state of health
- Non-smoker, ex-smoker for at least 3 months
- Regular menstrual cycle with a length between 21 and 35 days
- Written informed consent, after having been informed about benefits and potential risks of the clinical trial
Exclusion
- Existing diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the IMPs
- Subjects with severe allergies or multiple drug allergies
- Positive anti human immunodeficiency virus (anti-HIV) test, hepatitis B surface antigen (HBs-AG) test or anti hepatitis C virus (anti-HCV) test
- Presence or history of venous or arterial thrombosis, cerebrovascular accident, or increased risk of thrombosis
- Diabetes mellitus
- Unclarified vaginal bleeding or frequent infections of the urogenital tract
- Severe or chronic constipation
- Presence or history of migraine
- Drug or alcohol dependence
- Blood donation or other blood loss of more than 400 ml within the last 3 months
- Participation in a clinical trial during the last 6 months
- Pregnant or lactating women
- Subjects who do not agree to apply a barrier method for contraception
Key Trial Info
Start Date :
November 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2018
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03343912
Start Date
November 10 2017
End Date
February 15 2018
Last Update
May 7 2020
Active Locations (1)
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1
Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME
Campinas, São Paulo, Brazil