Trials Sponsors Conditions Drugs Pricing

Conditions

Contraception Female Healthy Women

Outcome Measures

Primary Outcomes (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 the Cmax.
Up to 24 days post ring insertion per period
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.
Up to 24 days post ring insertion per period
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.
Up to 24 days post ring insertion per period

Secondary Outcomes (2)

Safety and tolerability of the vaginal rings
through study completion, expected 102 days
Evaluate the vaginal local irritation and occurrence of bleeding/spotting
through study completion, expected 102 days

Study Arms (2)

EVE119 vaginal ring

EXPERIMENTAL

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

Combination Product: EVE119 vaginal ring

Nuvaring vaginal ring

ACTIVE COMPARATOR

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

Combination Product: Nuvaring vaginal ring

Interventions

EVE119 vaginal ringCombination product

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

EVE119 vaginal ring

Nuvaring vaginal ringCombination product

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

Nuvaring vaginal ring

Eligibility Criteria

Age18 Years - 45 Years

Sexfemale(Gender-based eligibility)

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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

Sponsors & Collaborators

Evestra Inc.
Industrylead

Study Sites (1)

Altasciences

Mount Royal, Quebec, Canada

Study Officials

Ze'ev Shaked, PhD
Evestra CEO
STUDY DIRECTOR

Enrollment

36 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Masking Details: Laboratory Blinded
Purpose: PREVENTION
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 1, 2023

First Posted

August 16, 2023

Study Start

July 29, 2023

Actual (reported)

You may not qualify if:

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
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
+22 more criteria

Comparative Bioavailability Study of Ethinyl Estradiol/Etonogestrel Vaginal Ring

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (2)

Study Arms (2)

EVE119 vaginal ring

Nuvaring vaginal ring

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (2)

Study Arms (2)

EVE119 vaginal ring

Nuvaring vaginal ring

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations