Trial Outcomes & Findings for Performance and Safety of Vaginal Ring Applicator in Healthy Females (MK-8342A-063) (NCT NCT02275546)

Results Overview

Participants completed a Post-Insertion Questionnaire in which they were asked about their experience inserting the vaginal ring. Their answers were recorded and evaluated.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

164 participants

Primary outcome timeframe

Day 1 (immediately after vaginal ring insertion)

Results posted on

2024-05-17

Participant Flow

Participant milestones

Participant milestones
Measure	Applicator→No Applicator (Manual) In Treatment Period 1, participants used the applicator to insert the vaginal ring. In Treatment Period 2 participants manually inserted the vaginal ring using their fingers only.	No Applicator (Manual)→Applicator In Treatment Period 1, participants manually inserted the vaginal ring using their fingers only. In Treatment Period 2, participants used the applicator to insert the vaginal ring.
Treatment Period 1 STARTED	81	83
Treatment Period 1 COMPLETED	81	83
Treatment Period 1 NOT COMPLETED	0	0
Treatment Period 2 STARTED	81	83
Treatment Period 2 COMPLETED	79	81
Treatment Period 2 NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Applicator→No Applicator (Manual) In Treatment Period 1, participants used the applicator to insert the vaginal ring. In Treatment Period 2 participants manually inserted the vaginal ring using their fingers only.	No Applicator (Manual)→Applicator In Treatment Period 1, participants manually inserted the vaginal ring using their fingers only. In Treatment Period 2, participants used the applicator to insert the vaginal ring.
Treatment Period 2 Withdrawal by Subject	2	1
Treatment Period 2 Protocol Violation	0	1

Baseline Characteristics

Performance and Safety of Vaginal Ring Applicator in Healthy Females (MK-8342A-063)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Randomized Participants n=164 Participants
Age, Continuous	30.2 Years STANDARD_DEVIATION 6.8 • n=5 Participants
Sex: Female, Male Female	164 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 (immediately after vaginal ring insertion)

Population: Per Protocol Population, which excluded participants due to important deviations from the protocol that could have substantially affected the results of the efficacy endpoints.

Participants completed a Post-Insertion Questionnaire in which they were asked about their experience inserting the vaginal ring. Their answers were recorded and evaluated.

Outcome measures

Outcome measures
Measure	Applicator n=102 Participants Participants used the applicator to insert the vaginal ring.	No Applicator (Manual) n=102 Participants Participants manually inserted the vaginal ring using their fingers only.
Percentage of Participants With Successful Ring Insertion	100 Percentage of participants Interval 96.4 to 100.0	100 Percentage of participants Interval 96.6 to 100.0

PRIMARY outcome

Timeframe: Up to 48 hours after vaginal ring insertion

Population: Per Protocol Population, which excluded participants due to important deviations from the protocol that could have substantially affected the results of the efficacy endpoints.

Participants completed a Follow-Up Questionnaire in which they asked if they experienced vaginal ring expulsion. Their answers were recorded and evaluated.

Outcome measures

Outcome measures
Measure	Applicator n=102 Participants Participants used the applicator to insert the vaginal ring.	No Applicator (Manual) n=102 Participants Participants manually inserted the vaginal ring using their fingers only.
Percentage of Participants With Vaginal Ring Expulsion Within 48 Hours of Insertion	0 Percentage of participants Interval 0.0 to 3.6	0 Percentage of participants Interval 0.0 to 3.6

Adverse Events

Applicator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Applicator (Manual)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.
Publication restrictions are in place

Restriction type: OTHER