22 Participants Needed

Hormone Interaction Study in Healthy Subjects

AC
Overseen ByAstraZeneca Clinical Study Information Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 5 JurisdictionsThis treatment is already approved in other countries

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?

Yes, EE/LNG is a promising drug because it has been shown to have consistent effects across different studies and does not significantly impact body weight or metabolism, which can help with patient compliance.23789

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

Have a Body Mass Index (BMI) between 18 and 30 kg/m2
I am not pregnant, breastfeeding, and cannot become pregnant.
I am postmenopausal, confirmed by lack of periods for 12 months, hormone levels, or surgery.

Exclusion Criteria

History of any clinically important disease or disorder which, in the opinion of the Investigator
Participants who are vegans or have medical dietary restrictions and vulnerable participants
Any positive result on screening for serum HBsAg, HBcAb, HCV or HIV
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Period 1

Participants receive oral dose of EE/LNG in the fasted state on Day 1, followed by PK sampling for 120 hours

5 days

Period 2

Participants self-administer baxdrostat once a day from Day 6 to Day 16

11 days

Period 3

Participants receive baxdrostat once daily and EE/LNG on Day 18, followed by PK sampling for 120 hours

7 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

  • Baxdrostat
  • EE/LNG
Trial Overview The study tests how multiple doses of Baxdrostat affect the body's handling of a single dose of combined oral contraceptives (Ethinyl Estradiol and Levonorgestrel). It also evaluates the safety and tolerability of Baxdrostat in these conditions.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Period 3: Baxdrostat + EE/LNGExperimental Treatment2 Interventions
Participants will receive baxdrostat once daily on Day 17 to Day 22 and will receive EE+LNG in the fasted state on Day 18, followed by oral dose of EE/LNG PK sampling for 120 hours (EE=72 hours and LNG=120 hours).
Group II: Period 2: BaxdrostatExperimental Treatment1 Intervention
Participants will self-administer the baxdrostat tablet once a day from Day 6 to Day 16.
Group III: Period 1: Ethinyl estradiol/Levonorgestrel (EE/LNG)Experimental Treatment1 Intervention
Participants will receive oral dose of EE/LNG in the fasted state on Day ,1 followed by PK sampling of EE/LNG for 120 hours (EE 72 hours and LNG 120 hours).

EE/LNG is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Ethinyl Estradiol/Levonorgestrel for:
  • Contraception
  • Menstrual disorders
🇪🇺
Approved in European Union as Ethinyl Estradiol/Levonorgestrel for:
  • Contraception
  • Menstrual disorders
  • Dysmenorrhea
🇨🇦
Approved in Canada as Ethinyl Estradiol/Levonorgestrel for:
  • Contraception
  • Menstrual disorders
🇯🇵
Approved in Japan as Ethinyl Estradiol/Levonorgestrel for:
  • Contraception
  • Menstrual disorders

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

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

Findings from Research

In a study involving 1515 women over 13 to 19 cycles, the new oral contraceptive regimen containing gestodene (60 microg) and ethinylestradiol (15 microg) demonstrated a very low pregnancy rate, with a Pearl index of 0.21, indicating high contraceptive efficacy.
The regimen was generally well-tolerated, although common side effects included headaches (35% of subjects) and absence of bleeding (16%), suggesting that while effective, some users may experience notable adverse effects.
The safety and contraceptive efficacy of a 24-day low-dose oral contraceptive regimen containing gestodene 60 microg and ethinylestradiol 15 microg.[2022]
Recent studies show that the pharmacokinetics of oral contraceptives like ethinyl estradiol (EE) and levonorgestrel (LNG) have moderate variability in drug exposure among women, indicating a more consistent understanding of their behavior in the body.
Over the past two decades, extensive research has been conducted on LNG and EE, leading to 17 publications that demonstrate similar pharmacokinetic profiles across various products and studies, suggesting reliability in their use as reference drugs for assessing drug interactions.
Perspectives on variability in pharmacokinetics of an oral contraceptive product.Jusko, WJ.[2018]
The study found that the effectiveness of levonorgestrel (LNG) in combined oral contraceptives can be significantly reduced by the presence of strong CYP3A4 inducers, leading to a decrease in LNG plasma levels by 50-75% depending on the woman's body mass index (BMI).
In women with a BMI of less than 25 kg/m2, the Pearl Index (a measure of contraceptive effectiveness) increased to 1.2-2.1 when using LNG in conjunction with CYP3A4 inducers, while in obese women, it rose to 1.6-2.85, indicating a higher risk of unintended pregnancies under these conditions.
Determining the Exposure Threshold for Levonorgestrel Efficacy Using an Integrated Model Based Meta-Analysis Approach.Lingineni, K., Chaturvedula, A., Cicali, B., et al.[2022]

References

The safety and contraceptive efficacy of a 24-day low-dose oral contraceptive regimen containing gestodene 60 microg and ethinylestradiol 15 microg. [2022]
Perspectives on variability in pharmacokinetics of an oral contraceptive product. [2018]
Determining the Exposure Threshold for Levonorgestrel Efficacy Using an Integrated Model Based Meta-Analysis Approach. [2022]
Ovulatory dysfunction during continuous administration of low-dose levonorgestrel by subdermal implants. [2017]
Drug-Drug Interaction Studies With Oral Contraceptives: Pharmacokinetic/Pharmacodynamic and Study Design Considerations. [2021]
The intrinsic transcriptional estrogenic activity of a non-phenolic derivative of levonorgestrel is mediated via the estrogen receptor-alpha. [2019]
Quantitative Assessment of Levonorgestrel Binding Partner Interplay and Drug-Drug Interactions Using Physiologically Based Pharmacokinetic Modeling. [2021]
Pharmacokinetics of ethinylestradiol and levonorgestrel after administration of two oral contraceptive preparations. [2013]
Effects on body weight and body composition of a low-dose oral estroprogestin containing ethinyl estradiol 20 microg plus levonorgestrel 100 microg. [2013]
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