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Healthy WomenPhase 1NCT05994599

Comparative Bioavailability Study of Ethinyl Estradiol/Etonogestrel Vaginal Ring

A Phase 1 study testing EVE119 vaginal ring and Nuvaring vaginal ring in people with Healthy Women and Female, run by Evestra Inc. at 1 site in Canada.

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

Single Dose Crossover Comparative Bioavailability Study of Ethinyl Estradiol/Etonogestrel Vaginal Ring (Delivering 0.015 mg/0.12 mg Per Day) Worn for 21 Days in Healthy Female Subjects 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
Healthy Women, Female, Contraception
What is being tested?
EVE119 vaginal ring and Nuvaring vaginal ring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteCanada
Study dates
29 Jul 2023to 11 Dec 2023
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

  • Provision of signed and dated Informed Consent Form (ICF)
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Healthy adult female
  • Meets 1 of the following criteria:
  • Is of childbearing potential and agrees to use an acceptable contraceptive method. Acceptable contraceptive methods include:
  • Abstinence from heterosexual intercourse from the Screening visit through to at least 28 days after the last vaginal ring removal
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  • The following double-barrier contraceptive methods, used from the Screening visit through to at least 28 days after the last vaginal ring removal:
  • Male condom with spermicide Or
  • Is of non-childbearing potential, defined as surgically sterile (ie, tubal ligation)
  • Aged at least 18 years but not older than 45 years in pre-menopausal state
  • Body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively
  • Non- or ex-smoker (An ex-smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first vaginal ring insertion)
  • Normal pap test result on file at Altasciences in the previous 12 months prior to the first vaginal ring insertion or normal pap test result at Screening
  • Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including breast and gynecological examination) and/or electrocardiogram (ECG), as determined by an Investigator

Who cannot join

  • Female who is lactating
  • Female who is pregnant according to the pregnancy test at Screening or prior to the first vaginal ring insertion
  • Use of the following systemic contraceptives: oral, patch, or vaginal ring, in the 28 days prior to the first vaginal insertion and until completion of the study
  • Use of hormone replacement therapy in the 28 days prior to the first vaginal insertion and until completion of the study
  • Use of the following systemic contraceptives: injections or implant, or hormone-releasing intrauterine device (IUD) in the 13 weeks prior to the first vaginal insertion and until completion of the study
  • Has contraindication for contraceptive steroids
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  • Post-menopausal status (minimum of a year without menses) and/or has undergone a complete hysterectomy or bilateral oophorectomy
  • Seated blood pressure higher than 140/90 mmHg at the Screening visit and prior to the first vaginal ring insertion, unless deemed non-significant by an Investigator
  • History of significant hypersensitivity to ethinyl estradiol, etonogestrel, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
  • Presence or history of significant genital, gastrointestinal, liver or kidney disease, or any other condition that is known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects
  • History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease, as defined by the Investigator
  • Presence of clinically significant ECG abnormalities at the Screening visit, as defined by the Investigator
  • Known presence or history of thrombophlebitis or any thromboembolic disorders (eg, venous thrombosis, arterial thrombosis), with or without pulmonary embolism
  • Known predisposition for venous or arterial thrombosis, with or without hereditary involvement such as Activated Protein C-resistance (including Factor V Leiden), antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia, and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant)
  • Known presence or history of classic migraine
  • Known presence of ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields
  • Known presence, suspected presence or history of cervical, breast, uterine, estrogen-dependent, or progestin-dependent cancer or other sex-steroid sensitive malignancies
  • Known presence or history of undiagnosed abnormal vaginal bleeding
  • Known presence of any condition that makes the use of the vaginal ring difficult such as prolapse of the uterine cervix, cystocele, and/or rectocele, severe or chronic constipation
  • Any other vaginal condition that would interfere with the vaginal ring or cause an increased health risk
  • Scheduled immunization with a Coronavirus Disease 2019 (COVID-19) vaccine during the study that, in the opinion of an Investigator, could potentially interfere with subject participation, subject safety, study results, or any other reason
  • Major surgery with prolonged immobilisation in the previous 6 months prior to the first vaginal ring insertion
  • Planned major elective surgery in the 3 months following removal of the vaginal ring
  • Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
  • Any clinically significant illness in the 28 days prior to the first vaginal ring insertion
  • Use of any prescription drugs in the 28 days prior to the first vaginal ring insertion, that in the opinion of an Investigator would put into question the status of the participant as healthy
  • Use of St. John's wort in the 28 days prior to the first vaginal ring insertion
  • Any history of tuberculosis
  • Positive test result for alcohol and/or drugs of abuse at Screening or prior to the first vaginal ring insertion
  • Positive screening results to HIV Ag/Ab combo, hepatitis B surface antigen, or hepatitis C virus tests
  • Serum ferritin value below 24 μg/L at Screening
  • Any other clinically significant abnormalities in laboratory test results at Screening that would, in the opinion of an Investigator, increase the subject's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data
  • Inclusion in a previous group for this clinical study
  • Intake of ethinyl estradiol or etonogestrel in the 28 days prior to the first vaginal ring insertion
  • Intake of an IP in the 28 days prior to the first vaginal ring insertion
  • Donation of 50 mL or more of blood in the 28 days prior to the first vaginal ring insertion
  • Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the 56 days prior to the first vaginal ring insertion
  • Hemoglobin laboratory values below the lower limit of the reference at Screening -

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Altasciences

    Mount Royal, Quebec

Other trials in Canada

About this study

Official title: SINGLE DOSE CROSSOVER COMPARATIVE BIOAVAILABILITY STUDY OF ETHINYL ESTRADIOL/ETONOGESTREL VAGINAL RING (DELIVERING 0.015 mg/0.12 mg PER DAY) WORN FOR 21 DAYS IN HEALTHY FEMALE SUBJECTS

Single Dose Crossover Comparative Bioavailability Study of Ethinyl Estradiol/Etonogestrel Vaginal Ring (Delivering 0.015 mg/0.12 mg Per Day) Worn for 21 Days in Healthy Female Subjects

Being tested
EVE119 vaginal ring, Nuvaring vaginal ring

What participants receive

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

  • EVE119 vaginal ringCombination product

    EVE119 (ethinyl estradiol/etonogestrel) vaginal ring delivering 0.015 mg/0.12 mg dose per day

  • Nuvaring vaginal ringCombination product

    Nuvaring® (ethinyl estradiol/etonogestrel) vaginal ring delivering 0.015 mg/0.12 mg dose per day

Study groups in NCT05994599
Study groupRoleWhat they receive
EVE119 vaginal ringExperimentalEVE119 (ethinyl estradiol/etonogestrel) vaginal ring delivering 0.015 mg/0.12 mg dose per day
Receives: Combination Product: EVE119 vaginal ring
Nuvaring vaginal ringActive comparatorNuvaring® (ethinyl estradiol/etonogestrel) vaginal ring delivering 0.015 mg/0.12 mg dose per day
Receives: Combination Product: Nuvaring vaginal ring

What is being measured

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

  1. Bioequivalence: evaluate and compare the bioavailability and therefore to assess the bioequivalence of 2 different formulations of ethinyl estradiol/etonogestrel vaginal ring

    The primary study endpoints are the pharmacokinetic (PK) parameter is the Cmax.

    Measured: Up to 24 days post ring insertion per period

  2. Bioequivalence: evaluate and compare the bioavailability and therefore to assess the bioequivalence of 2 different formulations of ethinyl estradiol/etonogestrel vaginal ring

    The primary study endpoints are the pharmacokinetic (PK) parameter is AUC0-T of ethinyl estradiol and etonogestrel.

    Measured: Up to 24 days post ring insertion per period

  3. Bioequivalence: evaluate and compare the bioavailability and therefore to assess the bioequivalence of 2 different formulations of ethinyl estradiol/etonogestrel vaginal ring

    The primary study endpoints are the pharmacokinetic (PK) parameter is and AUC0-∞ of ethinyl estradiol and etonogestrel.

    Measured: Up to 24 days post ring insertion per period

Secondary outcomes (2)

  1. Safety and tolerability of the vaginal rings

    Incidence and severity of treatment emergent adverse events (TEAEs) and serious TEAEs

    Measured: through study completion, expected 102 days

  2. Evaluate the vaginal local irritation and occurrence of bleeding/spotting

    Assessment of vaginal irritation and occurrence of bleeding/spotting through subject questionnaire/diary.

    Measured: through study completion, expected 102 days

Timeline

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

  1. First posted16 Aug 2023
  2. Study start29 Jul 2023
  3. Primary completion11 Dec 2023
  4. Study completion11 Dec 2023

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
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05994599
Sponsor's protocol ID
EVE-P6-604
Status last verified
Jun 2024
First submitted
1 Aug 2023
Last updated
24 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing EVE119 vaginal ring and Nuvaring vaginal ring in people with Healthy Women and Female, run by Evestra Inc. at 1 site in Canada.

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 14 inclusion and 38 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 24 Jun 2024. 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 Canada. 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?

Bioequivalence: evaluate and compare the bioavailability and therefore to assess the bioequivalence of 2 different formulations of ethinyl estradiol/etonogestrel vaginal ring (time frame: Up to 24 days post ring insertion per period). 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 NCT05994599.

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 24 Jun 2024.

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