Hormone Interaction Study in Healthy Subjects
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial does not specify if you must stop all current medications, but you cannot be on sex hormone therapy within one month before the study or strong CYP3A4 inhibitors or inducers within 3 months prior. Check with the trial team for more details.
What data supports the idea that Hormone Interaction Study in Healthy Subjects is an effective drug?
The available research shows that the combination of levonorgestrel (LNG) and ethinyl estradiol (EE) is effective as a contraceptive. Studies indicate that these drugs have consistent effects across different products and locations, suggesting reliability. Additionally, the research highlights that while factors like drug interactions and obesity can affect the drug's effectiveness, it generally remains effective unless combined with certain other drugs or in cases of obesity. This suggests that the drug is a reliable option for most users.12345
What safety data exists for the treatment involving Baxdrostat, CIN-107, EE/LNG, Ethinyl Estradiol/Levonorgestrel?
The safety data for Ethinyl Estradiol/Levonorgestrel (EE/LNG) primarily focuses on its pharmacokinetics and potential drug-drug interactions (DDIs). Studies indicate moderate variability in drug exposure indices across different formulations and conditions. The presence of CYP3A4 inducers can significantly decrease LNG plasma exposure, especially in obese women, potentially affecting contraceptive efficacy. Conversely, CYP3A4 inhibitors can increase LNG exposure. The estrogenic activity of LNG is mediated via the estrogen receptor-alpha, and its interaction with other drugs is a key consideration in clinical trials. Overall, the safety profile is influenced by factors like body mass index, co-administered drugs, and the specific hormonal formulation used.23567
Is the drug EE/LNG a promising treatment in the Hormone Interaction Study in Healthy Subjects?
What is the purpose of this trial?
The main purpose of the study is to assess the effect of multiple doses of baxdrostat on the pharmacokinetics (PK) of a single dose of combined oral ethinyl estradiol (EE) and levonorgestrel (LNG). Safety and tolerability of baxdrostat will be assessed during the study.
Eligibility Criteria
This trial is for healthy postmenopausal women or those who have had certain surgeries to ensure they cannot bear children. They should not be pregnant, lactating, and must have a BMI between 18-30 kg/m2. Women with a history of significant diseases, drug-related liver toxicity, thrombosis risks, cardiovascular issues, or severe allergies are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Period 1
Participants receive oral dose of EE/LNG in the fasted state on Day 1, followed by PK sampling for 120 hours
Period 2
Participants self-administer baxdrostat once a day from Day 6 to Day 16
Period 3
Participants receive baxdrostat once daily and EE/LNG on Day 18, followed by PK sampling for 120 hours
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Baxdrostat
- EE/LNG
EE/LNG is already approved in United States, European Union, Canada, Japan for the following indications:
- Contraception
- Menstrual disorders
- Contraception
- Menstrual disorders
- Dysmenorrhea
- Contraception
- Menstrual disorders
- Contraception
- Menstrual disorders
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology