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ContraceptionPhase 1NCT03512860

Estetrol (E4)/Drospirenone (DRSP) Drug-drug Interaction (DDI) Study

A Phase 1 study testing E4/DRSP and VAL in people with Contraception, run by Estetra at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The present study is designed to determine the effect of valproic acid (VAL), a UGT2B7 inhibiting drug, on the pharmacokinetics (PK) of estetrol (E4) Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception
What is being tested?
E4/DRSP and VAL
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited Kingdom
Study dates
12 Apr 2018to 8 Oct 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy premenopausal, aged 18-45 years (inclusive) at the time of signing informed consent.
  • 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.

Who cannot join

  • The use of:
  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Quotient Sciences

    Ruddington, Nottingham, NG11 6JS

Other trials in United Kingdom

About this study

Official title: An Open-label, Two-way Cross-over Study to Determine the Effect of Multiple Doses of Valproic Acid on the Pharmacokinetics and Safety of a Single Oral Dose of Estetrol/Drospirenone in Healthy Female Subjects

The present study is designed to determine the effect of valproic acid (VAL), a UGT2B7 inhibiting drug, on the pharmacokinetics (PK) of estetrol (E4)

Read the detailed description

In the present study, E4/DRSP will be administered alone (Treatment A) and in combination with VAL (Treatment B) following two sequences A-B or B-A.

Conditions
Contraception
Being tested
E4/DRSP, VAL
Keywords
Estetrol, Drospirenone, Uridine diphosphate glucuronosyltransferase-2B7, Drug-drug interaction, Valproic acid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E4/DRSPDrug

    Also called E4 and DRSP combined tablet

    Administered as specified in the treatment arm.

  • VALDrug

    Also called Valproic acid, Depakote®

    Administered as specified in the treatment arm.

Study groups in NCT03512860
Study groupRoleWhat they receive
E4/DRSP (Treatment A) - E4/DRSP + VAL (Treatment B)ExperimentalSequence 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.
Receives: Drug: E4/DRSP; Drug: VAL
E4/DRSP + VAL (Treatment B) - E4/DRSP (Treatment A)ExperimentalSequence 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).
Receives: Drug: E4/DRSP; Drug: VAL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum concentration (Cmax) of E4

    PK sampling

    Measured: 0-168 hr post E4/DRSP dose in both periods 1 and 2 of the two sequences A-B and B-A

  2. Area under the plasma concentration versus time curve from time 0 to the last determined concentration (AUC0-tdlc) of E4

    PK sampling

    Measured: 0-168 hr post E4/DRSP dose in both periods 1 and 2 of the two sequences A-B and B-A

  3. Area under the plasma concentration versus time curve from time 0 to infiny (AUC0-inf) of E4

    PK sampling

    Measured: 0-168 hr post E4/DRSP dose in both periods 1 and 2 of the two sequences A-B and B-A

Secondary outcomes (7)

  1. Number of subjects with adverse events as a measure of safety and tolerability

    Measured: The total study duration (between 50 and 86 days)

  2. Cmax of DRSP

    PK sampling

    Measured: 0-168 hr post E4/DRSP dose in both periods 1 and 2 of the two sequences A-B and B-A

  3. Cmax of E4-glucuronide metabolites

    PK sampling

    Measured: 0-168 hr post E4/DRSP dose in both periods 1 and 2 of the two sequences A-B and B-A

  4. AUC0-tdlc of DRSP

    PK sampling

    Measured: 0-168 hr post E4/DRSP dose in both periods 1 and 2 of the two sequences A-B and B-A

  5. AUC0-tdlc of E4-glucuronide metabolites

    PK sampling

    Measured: 0-168 hr post E4/DRSP dose in both periods 1 and 2 of the two sequences A-B and B-A

  6. AUC0-inf of DRSP

    PK sampling

    Measured: 0-168 hr post E4/DRSP dose in both periods 1 and 2 of the two sequences A-B and B-A

  7. AUC0-inf of E4-glucuronide metabolites

    PK sampling

    Measured: 0-168 hr post E4/DRSP dose in both periods 1 and 2 of the two sequences A-B and B-A

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2018
  2. Study start12 Apr 2018
  3. Primary completion8 Oct 2018
  4. Study completion8 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03512860
Sponsor's protocol ID
MIT-Es0001-C110
Other IDs
2017-004280-12, 2017
Status last verified
Dec 2018
First submitted
19 Apr 2018
Last updated
14 Dec 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing E4/DRSP and VAL in people with Contraception, run by Estetra at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum concentration (Cmax) of E4 (time frame: 0-168 hr post E4/DRSP dose in both periods 1 and 2 of the two sequences A-B and B-A). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03512860.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2018.

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