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Combined Oral Contraceptives

EE/LNG for Healthy Female Participants

Phase 1
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and day 15
Awards & highlights

Study Summary

This trial will look at the levels of a combination of two birth control hormones, ethinyl estradiol and levonorgestrel, in the blood when taken alone or with the drug zibotentan.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and day 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and day 15 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Apparent total body clearance of drug from plasma (CL/F)
Apparent volume of distribution based on terminal phase (Vz/F)
Area under plasma concentration time curve from zero to infinity (AUCinf)
+2 more
Secondary outcome measures
Area under plasma concentration-time curve in the dose interval (AUCtau)
Maximum observed plasma (peak) drug concentration (Cmax)
Number of participants with adverse events
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Zibotentan and EE/LNGExperimental Treatment2 Interventions
Participants will receive two tablets of combined oral EE/LNG on Day 1 with PK samples obtained from pre-dose on Day 1 until post-dose on Day 6. Participants will receive two capsules of zibotentan orally QD from Day 6 to Day 14. From Day 15 until Day 19 participants will continue to receive two capsules of zibotentan QD administered orally. On Day 15, participants will receive two tablets of combined oral EE and LNG with PK samples obtained pre-dose on Day 15 until post-dose (Day 20).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zibotentan
2019
Completed Phase 2
~810
EE/LNG
2022
Completed Phase 1
~30

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ParexelIndustry Sponsor
303 Previous Clinical Trials
100,802 Total Patients Enrolled
AstraZenecaLead Sponsor
4,262 Previous Clinical Trials
288,595,218 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential dangers are associated with EE/LNG for those undergoing treatment?

"The safety of EE/LNG is tentatively rated at 1, as this initial clinical trial has only provided minimal data to prove its efficacy and security."

Answered by AI

Who might be qualified for participation in this research project?

"This clinical trial is seeking 24 female patients between the ages of 35 and 75 years old to participate. To qualify, volunteers must provide written consent before any study-specific activities, be capable of adhering to all protocol requirements, possess healthy veins for cannulation or repeated venipuncture, have gone through postmenopausal transition (as evidenced by amenorrhea lasting 12 months since ceasing exogenous hormones with FSH levels above 40 mIU/mL), underwent irreversible surgical sterilization such as hysterectomy or bilateral oophorectomy/salpingectomy but not tubal ligation and finally present a BMI ranging from"

Answered by AI

Is this research program presently open for enrollment?

"Affirmative, the research is still recruiting subjects as indicated on clinicaltrials.gov. It was initially posted on August 24th 2022 and updated most recently on November 4th 2022; it seeks to include up to 24 patients from a single site in its trial."

Answered by AI

How many individuals are participating in the experiment?

"Affirmative. Clinicaltrials.gov confirms that this medical trial, which was initially uploaded on August 24th 2022 is in search of participants as its last update was November 4th 2022. The research team has to enlist a total of 24 individuals from 1 site."

Answered by AI

What aims is the research attempting to accomplish?

"The primary endpoint of this research is AUClast, which will be evaluated over the span of Day 1 and 15. Secondary objectives encompass Cmax, tmax, and a count of participants with adverse events. The pharmacokinetics (PK) properties in healthy female volunteers not capable of having children are also being assessed to determine safety and tolerability when combined with EE & LNG drugs."

Answered by AI

Is this research initiative available to seniors?

"For this clinical trial, only individuals between the ages of 35 and 75 are eligible to enroll."

Answered by AI
~9 spots leftby Apr 2025