Comparative Bioavailability Study of Ethinyl Estradiol/Etonogestrel Vaginal Ring

NCT05994599 | Completed Phase 1 FDA Drug

• 1 other identifier: EVE-P6-604
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy Women; Female; Contraception

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 ring COMBINATION_PRODUCT

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

EVE119 vaginal ring

Nuvaring vaginal ring COMBINATION_PRODUCT

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

Nuvaring vaginal ring

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (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
• 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
• 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

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

Sponsors & Collaborators

• Evestra Inc.: lead

Study Sites (1)

Altasciences

Mount Royal, Quebec, Canada

Location

Study Officials

• Ze'ev Shaked, PhD

  Evestra CEO

  STUDY DIRECTOR

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
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)