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Hormone Therapy
Vaginal Rings for Birth Control in Healthy Women
Phase 1
Recruiting
Research Sponsored by Evestra Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, expected 102 days
Awards & highlights
Study Summary
This trial tested if a vaginal hormone ring is safe and effective in releasing hormones for 21 days in healthy female subjects.
Eligible Conditions
- Healthy Women
- Female
- Birth Control
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, expected 102 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, expected 102 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bioequivalence: evaluate and compare the bioavailability and therefore to assess the bioequivalence of 2 different formulations of ethinyl estradiol/etonogestrel vaginal ring
Secondary outcome measures
Evaluate the vaginal local irritation and occurrence of bleeding/spotting
Safety and tolerability of the vaginal rings
Side effects data
From 2009 Phase 4 trial • 273 Patients • NCT0063557068%
Headaches
61%
Nausea
55%
Vaginal discomfort
54%
Bloating
52%
Breast swelling
34%
Vaginal discharge
12%
Weight gain
10%
Irregular menstruation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Contraceptive Vaginal Ring
Oral Contraceptive Pill
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: EVE119 vaginal ringExperimental Treatment1 Intervention
EVE119 (ethinyl estradiol/etonogestrel) vaginal ring delivering 0.015 mg/0.12 mg dose per day
Group II: Nuvaring vaginal ringActive Control1 Intervention
Nuvaring® (ethinyl estradiol/etonogestrel) vaginal ring delivering 0.015 mg/0.12 mg dose per day
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Evestra Inc.Lead Sponsor
Ze'ev Shaked, PhDStudy DirectorEvestra CEO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a significant history of genital, gastrointestinal, liver, or kidney disease, or any other condition that can affect how the drug works in your body or cause unwanted side effects.You have a history of serious heart, lung, blood, brain, mental health, hormone, immune system, or skin conditions.You cannot take birth control pills for medical reasons.You have a history of frequent severe headaches called "classic migraines."You have had unexplained abnormal vaginal bleeding in the past or currently.You have used St. John's wort in the 28 days before using the vaginal ring.You have had tuberculosis in the past.You must use a male condom with spermicide during the study.You have a problem with your eyes that affects your vision, such as loss of vision or visual field defects.You have any other vaginal condition that may make it difficult to use the vaginal ring or could increase your risk of health problems.You have had serious allergic reactions to ethinyl estradiol, etonogestrel, or similar medications, or experienced severe reactions like angioedema to any medications.You have a history of blood clots in your veins or arteries, which can include conditions like deep vein thrombosis or pulmonary embolism.You have had or may have had certain types of cancers related to the reproductive system or hormone sensitivity.You are currently on any medication for long-term treatment, or have had a significant history of drug addiction or alcohol abuse.
Research Study Groups:
This trial has the following groups:- Group 1: EVE119 vaginal ring
- Group 2: Nuvaring vaginal ring
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What assessments have been made to ascertain the security of EVE119 vaginal ring?
"Our team at Power rates EVE119 vaginal ring's safety as a 1 since this is an early-stage trial with limited evidence of efficacy and safety."
Answered by AI
What is the highest capacity of participants in this clinical research?
"Affirmative, the details on clinicaltrials.gov confirm that this research endeavour has begun searching for participants and was posted on July 28th 2023 with edits made 8 days later. 36 people are to be chosen from one medical facility."
Answered by AI
Is it possible for me to participate in this clinical research?
"This study seeks to enrol 36 women between the ages of 18 and 45. Those interested must meet this age and gender criteria in order to qualify for participation."
Answered by AI
Does the clinical trial accept participants who are over 25 years of age?
"This trial mandates that all participants be aged 18-45, abiding by the eligibility criteria."
Answered by AI
Is this research initiative recruiting participants?
"Affirmative. The clinicaltrials.gov webpage indicates that this medical experiment, which was first announced on July 28th 2023, is actively recruiting participants. A total of 36 people are sought for the trial at a single location."
Answered by AI
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