Trial Outcomes & Findings for Comparison of Vaginal Laser Therapy to Vaginal Estrogen Therapy (NCT NCT02691936)
NCT ID: NCT02691936
Last Updated: 2019-10-30
Results Overview
Vaginal dryness was assessed using a score of 0 (minimum) and 10 (maximum) on a Visual Analog Scale (VAS). Data presented is the mean difference before and after treatment. A higher mean difference signifies that the vaginal dryness score decreased to a greater measure hence resulting in a better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
69 participants
Primary outcome timeframe
6 months
Results posted on
2019-10-30
Participant Flow
Participant milestones
| Measure |
CO2 Fractionated Vaginal Laser
Postmenopausal women will undergo treatment intravaginally with the fractional microablative CO2 laser system MonaLisa Touch vaginal laser protocol x 3 time points at baseline, 6 weeks and 3 months.
CO2 fractionated vaginal laser: Intravaginal treatment with fractional microablative CO2 laser at baseline, 6 weeks and 3 months
|
Estrogens, Conjugated (USP)
The women in the vaginal estrogen group will be prescribed and asked to administer the conjugated estrogen cream 0.5 g of cream equivalent to 0.625 mg of conjugated estrogen.
Estrogens, Conjugated (USP): Conjugated estrogen cream 0.5g (equivalent of 0.625 mg of conjugated estrogen) daily for two weeks then twice weekly for 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
34
|
|
Overall Study
COMPLETED
|
33
|
29
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
CO2 Fractionated Vaginal Laser
Postmenopausal women will undergo treatment intravaginally with the fractional microablative CO2 laser system MonaLisa Touch vaginal laser protocol x 3 time points at baseline, 6 weeks and 3 months.
CO2 fractionated vaginal laser: Intravaginal treatment with fractional microablative CO2 laser at baseline, 6 weeks and 3 months
|
Estrogens, Conjugated (USP)
The women in the vaginal estrogen group will be prescribed and asked to administer the conjugated estrogen cream 0.5 g of cream equivalent to 0.625 mg of conjugated estrogen.
Estrogens, Conjugated (USP): Conjugated estrogen cream 0.5g (equivalent of 0.625 mg of conjugated estrogen) daily for two weeks then twice weekly for 24 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
Baseline Characteristics
Comparison of Vaginal Laser Therapy to Vaginal Estrogen Therapy
Baseline characteristics by cohort
| Measure |
CO2 Fractionated Vaginal Laser
n=35 Participants
Postmenopausal women will undergo treatment intravaginally with the fractional microablative CO2 laser system MonaLisa Touch vaginal laser protocol x 3 time points at baseline, 6 weeks and 3 months.
CO2 fractionated vaginal laser: Intravaginal treatment with fractional microablative CO2 laser at baseline, 6 weeks and 3 months
|
Estrogens, Conjugated (USP)
n=34 Participants
The women in the vaginal estrogen group will be prescribed and asked to administer the conjugated estrogen cream 0.5 g of cream equivalent to 0.625 mg of conjugated estrogen.
Estrogens, Conjugated (USP): Conjugated estrogen cream 0.5g (equivalent of 0.625 mg of conjugated estrogen) daily for two weeks then twice weekly for 24 weeks
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 8 • n=5 Participants
|
60 years
STANDARD_DEVIATION 7 • n=7 Participants
|
61 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
BMI
|
25.1 kg/m2
STANDARD_DEVIATION 4.7 • n=5 Participants
|
25.8 kg/m2
STANDARD_DEVIATION 4.4 • n=7 Participants
|
25.4 kg/m2
STANDARD_DEVIATION 4.6 • n=5 Participants
|
|
Parity
|
2 pregnancies
n=5 Participants
|
1 pregnancies
n=7 Participants
|
2 pregnancies
n=5 Participants
|
|
Menopausal
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Exogenous Hormone Use
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Vaginal Estrogen Use
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsVaginal dryness was assessed using a score of 0 (minimum) and 10 (maximum) on a Visual Analog Scale (VAS). Data presented is the mean difference before and after treatment. A higher mean difference signifies that the vaginal dryness score decreased to a greater measure hence resulting in a better outcome.
Outcome measures
| Measure |
CO2 Fractionated Vaginal Laser
n=33 Participants
Postmenopausal women will undergo treatment intravaginally with the fractional microablative CO2 laser system MonaLisa Touch vaginal laser protocol x 3 time points at baseline, 6 weeks and 3 months.
CO2 fractionated vaginal laser: Intravaginal treatment with fractional microablative CO2 laser at baseline, 6 weeks and 3 months
|
Estrogens, Conjugated (USP)
n=29 Participants
The women in the vaginal estrogen group will be prescribed and asked to administer the conjugated estrogen cream 0.5 g of cream equivalent to 0.625 mg of conjugated estrogen.
Estrogens, Conjugated (USP): Conjugated estrogen cream 0.5g (equivalent of 0.625 mg of conjugated estrogen) daily for two weeks then twice weekly for 24 weeks
|
|---|---|---|
|
Vaginal Dryness
|
-5.48 units on a scale
Interval -8.16 to -2.8
|
-5.76 units on a scale
Interval -8.24 to -3.28
|
SECONDARY outcome
Timeframe: 6 monthsVaginal health index (VHI) score is measured on a scale of 0 (minimum) to 5 (maximum) and higher scores means a better outcome.
Outcome measures
| Measure |
CO2 Fractionated Vaginal Laser
n=33 Participants
Postmenopausal women will undergo treatment intravaginally with the fractional microablative CO2 laser system MonaLisa Touch vaginal laser protocol x 3 time points at baseline, 6 weeks and 3 months.
CO2 fractionated vaginal laser: Intravaginal treatment with fractional microablative CO2 laser at baseline, 6 weeks and 3 months
|
Estrogens, Conjugated (USP)
n=29 Participants
The women in the vaginal estrogen group will be prescribed and asked to administer the conjugated estrogen cream 0.5 g of cream equivalent to 0.625 mg of conjugated estrogen.
Estrogens, Conjugated (USP): Conjugated estrogen cream 0.5g (equivalent of 0.625 mg of conjugated estrogen) daily for two weeks then twice weekly for 24 weeks
|
|---|---|---|
|
Objective Evaluation of Vaginal Atrophy/Estrogenization
|
0.9 units on a scale
Interval 0.2 to 1.6
|
1.2 units on a scale
Interval 0.3 to 2.1
|
SECONDARY outcome
Timeframe: 6 monthsDIVA scores are based on a scale of 0 (minimum) to 20 (maximum) with higher scores representing worse outcomes. The data presented are mean differences before and after treatment.
Outcome measures
| Measure |
CO2 Fractionated Vaginal Laser
n=33 Participants
Postmenopausal women will undergo treatment intravaginally with the fractional microablative CO2 laser system MonaLisa Touch vaginal laser protocol x 3 time points at baseline, 6 weeks and 3 months.
CO2 fractionated vaginal laser: Intravaginal treatment with fractional microablative CO2 laser at baseline, 6 weeks and 3 months
|
Estrogens, Conjugated (USP)
n=29 Participants
The women in the vaginal estrogen group will be prescribed and asked to administer the conjugated estrogen cream 0.5 g of cream equivalent to 0.625 mg of conjugated estrogen.
Estrogens, Conjugated (USP): Conjugated estrogen cream 0.5g (equivalent of 0.625 mg of conjugated estrogen) daily for two weeks then twice weekly for 24 weeks
|
|---|---|---|
|
Effect of GMS Symptoms on Quality of Life
|
-3.3 units on a scale
Interval -6.5 to -0.1
|
-4.4 units on a scale
Interval -7.5 to -1.3
|
SECONDARY outcome
Timeframe: 6 monthsVaginal Maturity Index (VMI) scores are from 0 (minimum) to 100 (maximum) with higher scores representing higher maturity which is a favorable (better) outcome. The results reported are the difference between 2 time points (baseline and 6 month follow up). A change in outcome which is negative signifies a worse outcome. Conversely, a positive change signifies improvement.
Outcome measures
| Measure |
CO2 Fractionated Vaginal Laser
n=33 Participants
Postmenopausal women will undergo treatment intravaginally with the fractional microablative CO2 laser system MonaLisa Touch vaginal laser protocol x 3 time points at baseline, 6 weeks and 3 months.
CO2 fractionated vaginal laser: Intravaginal treatment with fractional microablative CO2 laser at baseline, 6 weeks and 3 months
|
Estrogens, Conjugated (USP)
n=29 Participants
The women in the vaginal estrogen group will be prescribed and asked to administer the conjugated estrogen cream 0.5 g of cream equivalent to 0.625 mg of conjugated estrogen.
Estrogens, Conjugated (USP): Conjugated estrogen cream 0.5g (equivalent of 0.625 mg of conjugated estrogen) daily for two weeks then twice weekly for 24 weeks
|
|---|---|---|
|
Effect of Treatment on Vaginal Maturation Index
|
3.9 units on a scale
Interval -26.7 to 34.5
|
25 units on a scale
Interval 2.4 to 47.6
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The data above are represented in tabular form.
Participants who were able to tolerate a larger dilator size compared to before treatment (representing improvement in vaginal wall elasticity) were marked as "yes" and participants who could not tolerate a larger size (representing no change in vaginal elasticity) were marked as "no".
Outcome measures
| Measure |
CO2 Fractionated Vaginal Laser
n=33 Participants
Postmenopausal women will undergo treatment intravaginally with the fractional microablative CO2 laser system MonaLisa Touch vaginal laser protocol x 3 time points at baseline, 6 weeks and 3 months.
CO2 fractionated vaginal laser: Intravaginal treatment with fractional microablative CO2 laser at baseline, 6 weeks and 3 months
|
Estrogens, Conjugated (USP)
n=29 Participants
The women in the vaginal estrogen group will be prescribed and asked to administer the conjugated estrogen cream 0.5 g of cream equivalent to 0.625 mg of conjugated estrogen.
Estrogens, Conjugated (USP): Conjugated estrogen cream 0.5g (equivalent of 0.625 mg of conjugated estrogen) daily for two weeks then twice weekly for 24 weeks
|
|---|---|---|
|
Vaginal Wall Elasticity Assessed by Number of Participants Able to Tolerate a Larger Vaginal Dilator Size
|
16 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 6 monthsFemale Sexual Function Index (FSFI) scores are on a scale of 0 (minimum) to 36 (maximum) with higher scores representing more favorable outcomes. The scores represent the difference between baseline and 6 month follow up. A negative difference signifies worsened function whereas a positive difference signifies improvement.
Outcome measures
| Measure |
CO2 Fractionated Vaginal Laser
n=33 Participants
Postmenopausal women will undergo treatment intravaginally with the fractional microablative CO2 laser system MonaLisa Touch vaginal laser protocol x 3 time points at baseline, 6 weeks and 3 months.
CO2 fractionated vaginal laser: Intravaginal treatment with fractional microablative CO2 laser at baseline, 6 weeks and 3 months
|
Estrogens, Conjugated (USP)
n=29 Participants
The women in the vaginal estrogen group will be prescribed and asked to administer the conjugated estrogen cream 0.5 g of cream equivalent to 0.625 mg of conjugated estrogen.
Estrogens, Conjugated (USP): Conjugated estrogen cream 0.5g (equivalent of 0.625 mg of conjugated estrogen) daily for two weeks then twice weekly for 24 weeks
|
|---|---|---|
|
Effect of Treatment on Female Sexual Function
|
1.7 units on a scale
Interval -5.0 to 8.4
|
4.9 units on a scale
Interval -3.4 to 13.2
|
SECONDARY outcome
Timeframe: 6 monthsUrogenital distress inventory (UDI-6) is measures on a scale of 0 (minimum) to 75 (maximum) with higher scores representing less favorable outcomes (more severe urinary symptoms). Data here are presented as mean differences from before and after treatment.
Outcome measures
| Measure |
CO2 Fractionated Vaginal Laser
n=33 Participants
Postmenopausal women will undergo treatment intravaginally with the fractional microablative CO2 laser system MonaLisa Touch vaginal laser protocol x 3 time points at baseline, 6 weeks and 3 months.
CO2 fractionated vaginal laser: Intravaginal treatment with fractional microablative CO2 laser at baseline, 6 weeks and 3 months
|
Estrogens, Conjugated (USP)
n=29 Participants
The women in the vaginal estrogen group will be prescribed and asked to administer the conjugated estrogen cream 0.5 g of cream equivalent to 0.625 mg of conjugated estrogen.
Estrogens, Conjugated (USP): Conjugated estrogen cream 0.5g (equivalent of 0.625 mg of conjugated estrogen) daily for two weeks then twice weekly for 24 weeks
|
|---|---|---|
|
Effect of Treatment on Urinary Symptoms
|
-9.4 units on a scale
Interval -25.1 to 6.3
|
-6.2 units on a scale
Interval -18.2 to 5.8
|
SECONDARY outcome
Timeframe: 6 monthsPatient global impression of improvement (PGI) is a 5-point Likert scale evaluating patient satisfaction after treatment. The 5-point Likert scale for satisfaction indicates 1(Very dissatisfied), 2(Dissatisfied), 3(Same), 4(Satisfied) or 5(Very satisfied). As reported, the responses for level of dissatisfaction after treatment on the Patient Global Index included responses of very dissatisfied and dissatisfied. This is directly out of the questionnaire given to the patient to complete.
Outcome measures
| Measure |
CO2 Fractionated Vaginal Laser
n=33 Participants
Postmenopausal women will undergo treatment intravaginally with the fractional microablative CO2 laser system MonaLisa Touch vaginal laser protocol x 3 time points at baseline, 6 weeks and 3 months.
CO2 fractionated vaginal laser: Intravaginal treatment with fractional microablative CO2 laser at baseline, 6 weeks and 3 months
|
Estrogens, Conjugated (USP)
n=29 Participants
The women in the vaginal estrogen group will be prescribed and asked to administer the conjugated estrogen cream 0.5 g of cream equivalent to 0.625 mg of conjugated estrogen.
Estrogens, Conjugated (USP): Conjugated estrogen cream 0.5g (equivalent of 0.625 mg of conjugated estrogen) daily for two weeks then twice weekly for 24 weeks
|
|---|---|---|
|
Rate of Satisfaction of Patients With Treatment
Better or much better
|
24 Participants
|
24 Participants
|
|
Rate of Satisfaction of Patients With Treatment
Satisfied or very satisfied
|
25 Participants
|
22 Participants
|
|
Rate of Satisfaction of Patients With Treatment
Dissatisfied
|
3 Participants
|
2 Participants
|
Adverse Events
CO2 Fractionated Vaginal Laser
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Estrogens, Conjugated (USP)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CO2 Fractionated Vaginal Laser
n=33 participants at risk
Postmenopausal women will undergo treatment intravaginally with the fractional microablative CO2 laser system MonaLisa Touch vaginal laser protocol x 3 time points at baseline, 6 weeks and 3 months.
CO2 fractionated vaginal laser: Intravaginal treatment with fractional microablative CO2 laser at baseline, 6 weeks and 3 months
|
Estrogens, Conjugated (USP)
n=29 participants at risk
The women in the vaginal estrogen group will be prescribed and asked to administer the conjugated estrogen cream 0.5 g of cream equivalent to 0.625 mg of conjugated estrogen.
Estrogens, Conjugated (USP): Conjugated estrogen cream 0.5g (equivalent of 0.625 mg of conjugated estrogen) daily for two weeks then twice weekly for 24 weeks
|
|---|---|---|
|
Reproductive system and breast disorders
Vaginal bleeding
|
6.1%
2/33 • Number of events 2 • 6 months
|
6.9%
2/29 • Number of events 2 • 6 months
|
|
Reproductive system and breast disorders
Pain
|
3.0%
1/33 • Number of events 1 • 6 months
|
0.00%
0/29 • 6 months
|
|
Reproductive system and breast disorders
Discharge
|
3.0%
1/33 • Number of events 1 • 6 months
|
0.00%
0/29 • 6 months
|
|
Reproductive system and breast disorders
Breast Tenderness
|
0.00%
0/33 • 6 months
|
3.4%
1/29 • Number of events 1 • 6 months
|
|
Reproductive system and breast disorders
UTI
|
3.0%
1/33 • Number of events 1 • 6 months
|
0.00%
0/29 • 6 months
|
|
Nervous system disorders
Migraine
|
0.00%
0/33 • 6 months
|
3.4%
1/29 • Number of events 1 • 6 months
|
|
Reproductive system and breast disorders
Abdomial cramping
|
0.00%
0/33 • 6 months
|
3.4%
1/29 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place