Trial Outcomes & Findings for Ethylvinyl Acetate (EVA) Vaginal Ring Delivery System Study (NCT NCT00706784)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

6 participants

Primary outcome timeframe

8 hours

Results posted on

2014-06-26

Withdrawal data not reported

Ethylvinyl Acetate (EVA) Vaginal Ring Delivery System Study

Baseline characteristics by cohort
Measure	18 mg Leuprolide for 3 Days n=3 Participants	36 mg Leuprolide for 3 Days n=3 Participants	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

Timeframe: 8 hours

Outcome measures
Measure	18 mg Leuprolide for 3 Days n=3 Participants	36 mg Leuprolide for 3 Days n=3 Participants
Serum Leuprolide Levels After EVA Ring Transvaginal Drug Delivery System Insertion	310 pg/ml Standard Deviation 221	1220 pg/ml Standard Deviation 735

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	18 mg Leuprolide for 3 Days n=3 participants at risk	36 mg Leuprolide for 3 Days n=3 participants at risk
Reproductive system and breast disorders Displacement of Vaginal Ring	66.7% 2/3 • Number of events 2 • 3 days	0.00% 0/3 • 3 days

MGH

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