Estetrol (E4)/Drospirenone (DRSP) Drug-drug Interaction (DDI) Study
NCT ID: NCT03512860
Last Updated: 2018-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2018-04-12
2018-10-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
E4/DRSP Single and Multiple Dose PK and Early QT Study
NCT02874248
Safety, Compliance and Pharmacokinetics of Estetrol Monohydrate/Drospirenone 15/3 mg in Post-menarchal Female Adolescents
NCT04792385
Effect of Food on the Bioavailability of 15 mg Estetrol/3 mg Drospirenone Tablets in Healthy Female Volunteers
NCT02852681
Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea
NCT00461305
"E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study"
NCT02957630
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
E4/DRSP (Treatment A) - E4/DRSP + VAL (Treatment B)
Sequence A-B: A single oral dose of E4 combined with DRSP (Treatment A) will be administered during the Period 1. After a washout, subjects will enter into the Period 2. They will receive the Treatment B which consists in multiple oral doses of VAL for 12 consecutive days and one single oral dose of E4/DRSP on Day 5 of the VAL administration.
E4/DRSP
Administered as specified in the treatment arm.
VAL
Administered as specified in the treatment arm.
E4/DRSP + VAL (Treatment B) - E4/DRSP (Treatment A)
Sequence B-A: During Period 1, subjects will receive the Treatment B (multiple oral doses of VAL for 12 consecutive days and one single oral dose of E4/DRSP on Day 5 of the VAL administration) . After a washout, subjects will enter into the Period 2 and receive the Treatment A (a single oral dose of E4 combined with DRSP).
E4/DRSP
Administered as specified in the treatment arm.
VAL
Administered as specified in the treatment arm.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
E4/DRSP
Administered as specified in the treatment arm.
VAL
Administered as specified in the treatment arm.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* For subjects who are sexually active and are of childbearing potential: willing to use a highly effective non-hormonal method of contraception from screening until the follow-up assessment, such as (but not limited to): non-hormonal intra-uterine device (copper IUD), bilateral tubal occlusion, vasectomised partner, or sexual abstinence in a heterosexual relationship; this is acceptable when it is in line with the subject's preferred and usual lifestyle. If a subject is usually not sexually active but becomes active, they, with their partner, must comply with the contraceptive requirements as stated earlier.
* Body weight ≥45 kg, and a body mass index between 18.0 and 30.0 kg/m² (inclusive).
* Negative serum pregnancy test at screening and a negative urine pregnancy test at Day -1.
Exclusion Criteria
* any prescription drugs, including oral or vaginal hormonal contraceptives, from 28 days prior to first dose administration until study completion;
* any herbal medication or dietary supplements acting on cytochrome P450 3A4 (CYP3A4) functions (i.e., St John's Wort), from 28 days prior to first dose administration until study completion;
* any over-the-counter medication (including paracetamol or dietary supplements (including vitamins and herbal products ), from 14 days prior to first dose administration until study completion. Limited use (i.e., up to 1200 mg/day) of ibuprofen is allowed;
* any depot progestogen preparations or an injectable hormonal method of contraception, from 6 months prior to the first dose administration until study completion.
* History of hypersensitivity, serious adverse reaction, or existing contraindication to E4, DRSP or VAL, or excipients.
18 Years
45 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Quotient Sciences
INDUSTRY
Estetra
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sharan Sidhu
Role: PRINCIPAL_INVESTIGATOR
Quotient Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Quotient Sciences
Ruddington, Nottingham, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-004280-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MIT-Es0001-C110
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.