Trial Outcomes & Findings for Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy (NCT NCT02085980)

Results Overview

The main outcome of the study is the efficacy of the laser procedure, intended as the amelioration of 50% of the severity of the vaginal dryness at 12 months, compared with baseline. The change in the vaginal dryness symptom has been assessed by means of a visual analogic scale (10 cm VAS).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Baseline and at follow up visit at 12 months post last treatment

Results posted on

2021-06-04

Participant Flow

Participant milestones

Participant milestones
Measure	Laser Treatment Laser Treatment Laser treatment: The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece
Overall Study STARTED	30
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Laser Treatment n=30 Participants Laser Treatment Laser treatment: The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece
Age, Continuous	58.6 years STANDARD_DEVIATION 8.8 • n=30 Participants
Sex: Female, Male Female	30 Participants n=30 Participants
Sex: Female, Male Male	0 Participants n=30 Participants

PRIMARY outcome

Timeframe: Baseline and at follow up visit at 12 months post last treatment

The main outcome of the study is the efficacy of the laser procedure, intended as the amelioration of 50% of the severity of the vaginal dryness at 12 months, compared with baseline. The change in the vaginal dryness symptom has been assessed by means of a visual analogic scale (10 cm VAS).

Outcome measures

Outcome measures
Measure	Laser Treatment n=30 Participants Laser Treatment Laser treatment: The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece
The Main Outcome of the Study is the Efficacy of the Laser Procedure, Intended as the Amelioration of 50% of the Severity of the Vaginal Dryness at 12 Months, Compared With Baseline	27 Participants

Adverse Events

Laser Treatment

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

Dr. Mickey Karram

The Christ Hospital - Cincinnati, OH

Phone: (513) 463-2500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place