Ignite Creation Date:
2024-05-06 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03432416
Status:
UNKNOWN
Last Update Posted:
2019-05-20
First Post:
2018-01-22
Brief Title:
Study of Efficacy Cycle Control and Safety of a NES-E2 Contraceptive Vaginal Ring
Sponsor:
Health Decisions
Organization:
Health Decisions
Study Overview
Official Title:
A Multicenter Open-label Randomized Study on the Efficacy Cycle Control and Safety of a Contraceptive Vaginal Ring Delivering a Daily Dose of Nestorone and Estradiol NES-E2 CVR
Status:
UNKNOWN
Status Verified Date:
2019-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This will be a multi-site open-label randomized clinical trial The investigators will randomize 300 eligible participants in a 11 ratio to two different treatment regimens that are to be followed when using a contraceptive vaginal ring delivering a daily dose of Nestorone and estradiol NES-E2 CVR
Detailed Description:
The total duration of the study for each participant is expected to be approximately 135-155 months including screening and enrollment up to 8 weeks 12 months of participation and a post-removal follow up period removal of at least 17 days After enrollment subject visits occur at day 31 92 183 274 and 364 with telephone calls at day 60 120 150 210 240 300 and 330 Subjects will use a home pregnancy test 17 days post-removal of the ring and will call the site report the result and for safety follow-up Another phone call will be required after that if the subject chooses not to being a hormonal contraceptive this call will occur at the time of the subjects first spontaneous menses
Subject recruitment is expected to begin Q1 in the first quarter of 2018 and is planned to continue through Q1 2019 However if the enrollment rate declines the enrollment period may be extended beyond this date If this enrollment timeline is met all subjects should finish active treatment by approximately the end of Q1 2020 The end of the study will occur when the last subject to be enrolled has completed her post-removal telephone calls
Preliminary results of the study are expected to be available Q3 of 2020 based on the current study plan
Subject recruitment is expected to begin Q1 in the first quarter of 2018 and is planned to continue through Q1 2019 However if the enrollment rate declines the enrollment period may be extended beyond this date If this enrollment timeline is met all subjects should finish active treatment by approximately the end of Q1 2020 The end of the study will occur when the last subject to be enrolled has completed her post-removal telephone calls
Preliminary results of the study are expected to be available Q3 of 2020 based on the current study plan
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None