Trial Outcomes & Findings for The Vaginal Health Trial (NCT NCT02516202)
NCT ID: NCT02516202
Last Updated: 2018-07-12
Results Overview
Mean change from baseline to 12 weeks in the severity of the MBS on a scale of 0-3, better to worse.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
302 participants
Primary outcome timeframe
Baseline, Week 4, Week 12
Results posted on
2018-07-12
Participant Flow
Participant milestones
| Measure |
Vagifem
One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg). One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.
Vagifem® tablets contain 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. The excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Vagifem® comes as a small white film-coated tablet. The coating is made of hypromellose and polyethylene glycol.
A placebo vaginal gel visually identical composed of inert hydroxyethylcellulose gel (pH adjusted) applied every 3 days over entire 12 weeks.
Vagifem: One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.
|
Replens
One hundred participants will be randomized into the Replens® 'active' arm. These women will receive a tube containing Replens® vaginal gel. 2.5 gm to be applied vaginally every 3 days over 12 weeks.
Replens® is a bioadhesive polycarbophil-based moisturizing vaginal gel containing; purified water (vehicle humectant), glycerin (moisturizer), mineral oil (as a moisturizer), polycarbophil and carbomer homopolymer type B (allow the product to stick to the vaginal wall), hydrogenated palm oil glyceride (moisturizer), sorbic acid (preservative, antimicrobial), methylparaben, sodium hydroxide (adjusts pH of product so it is suitable for vaginal use).
A placebo vaginal tablet visually identical to Vagifem® is inserted daily for 2 weeks, then 2 days/week for remaining 10 weeks.
Replens: 2.5 gm to be applied vaginally every 3 days over 12 weeks.
Placebo: Dispensed in visually identical bottle and tablet form.
|
Placebo
One hundred participants will be randomized into the 'placebo arm' of the study. This arm is comprised of two placebo preparations; placebo vaginal tablet and placebo vaginal gel applied on the same schedule as 'active' arms.
The placebo tablet coating and excipient ingredients will be the same as are used for Vagifem®; the coating is made of hypromellose and polyethylene glycol and the excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate.
Placebo vaginal gel. The product is a inert hydroxyethylcellulose gel (pH adjusted).
Placebo: Dispensed in visually identical bottle and tablet form.
Placebo: Dispensed in visually identical tube and gel form.
|
|---|---|---|---|
|
Overall Study
STARTED
|
102
|
100
|
100
|
|
Overall Study
COMPLETED
|
100
|
99
|
97
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
3
|
Reasons for withdrawal
| Measure |
Vagifem
One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg). One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.
Vagifem® tablets contain 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. The excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Vagifem® comes as a small white film-coated tablet. The coating is made of hypromellose and polyethylene glycol.
A placebo vaginal gel visually identical composed of inert hydroxyethylcellulose gel (pH adjusted) applied every 3 days over entire 12 weeks.
Vagifem: One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.
|
Replens
One hundred participants will be randomized into the Replens® 'active' arm. These women will receive a tube containing Replens® vaginal gel. 2.5 gm to be applied vaginally every 3 days over 12 weeks.
Replens® is a bioadhesive polycarbophil-based moisturizing vaginal gel containing; purified water (vehicle humectant), glycerin (moisturizer), mineral oil (as a moisturizer), polycarbophil and carbomer homopolymer type B (allow the product to stick to the vaginal wall), hydrogenated palm oil glyceride (moisturizer), sorbic acid (preservative, antimicrobial), methylparaben, sodium hydroxide (adjusts pH of product so it is suitable for vaginal use).
A placebo vaginal tablet visually identical to Vagifem® is inserted daily for 2 weeks, then 2 days/week for remaining 10 weeks.
Replens: 2.5 gm to be applied vaginally every 3 days over 12 weeks.
Placebo: Dispensed in visually identical bottle and tablet form.
|
Placebo
One hundred participants will be randomized into the 'placebo arm' of the study. This arm is comprised of two placebo preparations; placebo vaginal tablet and placebo vaginal gel applied on the same schedule as 'active' arms.
The placebo tablet coating and excipient ingredients will be the same as are used for Vagifem®; the coating is made of hypromellose and polyethylene glycol and the excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate.
Placebo vaginal gel. The product is a inert hydroxyethylcellulose gel (pH adjusted).
Placebo: Dispensed in visually identical bottle and tablet form.
Placebo: Dispensed in visually identical tube and gel form.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
|
Overall Study
Stopped Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
6 participants have missing data on BMI
Baseline characteristics by cohort
| Measure |
Vagifem
n=102 Participants
One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg). One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.
Vagifem® tablets contain 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. The excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Vagifem® comes as a small white film-coated tablet. The coating is made of hypromellose and polyethylene glycol.
A placebo vaginal gel visually identical composed of inert hydroxyethylcellulose gel (pH adjusted) applied every 3 days over entire 12 weeks.
Vagifem: One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.
|
Replens
n=100 Participants
One hundred participants will be randomized into the Replens® 'active' arm. These women will receive a tube containing Replens® vaginal gel. 2.5 gm to be applied vaginally every 3 days over 12 weeks.
Replens® is a bioadhesive polycarbophil-based moisturizing vaginal gel containing; purified water (vehicle humectant), glycerin (moisturizer), mineral oil (as a moisturizer), polycarbophil and carbomer homopolymer type B (allow the product to stick to the vaginal wall), hydrogenated palm oil glyceride (moisturizer), sorbic acid (preservative, antimicrobial), methylparaben, sodium hydroxide (adjusts pH of product so it is suitable for vaginal use).
A placebo vaginal tablet visually identical to Vagifem® is inserted daily for 2 weeks, then 2 days/week for remaining 10 weeks.
Replens: 2.5 gm to be applied vaginally every 3 days over 12 weeks.
Placebo: Dispensed in visually identical bottle and tablet form.
|
Placebo
n=100 Participants
One hundred participants will be randomized into the 'placebo arm' of the study. This arm is comprised of two placebo preparations; placebo vaginal tablet and placebo vaginal gel applied on the same schedule as 'active' arms.
The placebo tablet coating and excipient ingredients will be the same as are used for Vagifem®; the coating is made of hypromellose and polyethylene glycol and the excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate.
Placebo vaginal gel. The product is a inert hydroxyethylcellulose gel (pH adjusted).
Placebo: Dispensed in visually identical bottle and tablet form.
Placebo: Dispensed in visually identical tube and gel form.
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 4 • n=102 Participants
|
61 years
STANDARD_DEVIATION 4 • n=100 Participants
|
61 years
STANDARD_DEVIATION 4 • n=100 Participants
|
61 years
STANDARD_DEVIATION 4 • n=302 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=102 Participants
|
100 Participants
n=100 Participants
|
100 Participants
n=100 Participants
|
302 Participants
n=302 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=102 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=302 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
87 Participants
n=102 Participants
|
90 Participants
n=100 Participants
|
90 Participants
n=100 Participants
|
267 Participants
n=302 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
7 Participants
n=102 Participants
|
3 Participants
n=100 Participants
|
2 Participants
n=100 Participants
|
12 Participants
n=302 Participants
|
|
Race/Ethnicity, Customized
Race · Other / unknown
|
8 Participants
n=102 Participants
|
7 Participants
n=100 Participants
|
8 Participants
n=100 Participants
|
23 Participants
n=302 Participants
|
|
Body Mass Index (BMI)
|
27 kg/m^2
STANDARD_DEVIATION 5 • n=98 Participants • 6 participants have missing data on BMI
|
26 kg/m^2
STANDARD_DEVIATION 4 • n=100 Participants • 6 participants have missing data on BMI
|
26 kg/m^2
STANDARD_DEVIATION 6 • n=98 Participants • 6 participants have missing data on BMI
|
26 kg/m^2
STANDARD_DEVIATION 5 • n=296 Participants • 6 participants have missing data on BMI
|
|
Education
High school diploma / GED or less
|
2 Participants
n=102 Participants
|
3 Participants
n=100 Participants
|
6 Participants
n=100 Participants
|
11 Participants
n=302 Participants
|
|
Education
School after high school
|
31 Participants
n=102 Participants
|
27 Participants
n=100 Participants
|
31 Participants
n=100 Participants
|
89 Participants
n=302 Participants
|
|
Education
College graduate
|
67 Participants
n=102 Participants
|
70 Participants
n=100 Participants
|
63 Participants
n=100 Participants
|
200 Participants
n=302 Participants
|
|
Education
Missing
|
2 Participants
n=102 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
2 Participants
n=302 Participants
|
|
Marital status
Never married
|
8 Participants
n=102 Participants
|
2 Participants
n=100 Participants
|
4 Participants
n=100 Participants
|
14 Participants
n=302 Participants
|
|
Marital status
Divorced or widowed
|
10 Participants
n=102 Participants
|
8 Participants
n=100 Participants
|
12 Participants
n=100 Participants
|
30 Participants
n=302 Participants
|
|
Marital status
Married or like relationship
|
83 Participants
n=102 Participants
|
90 Participants
n=100 Participants
|
84 Participants
n=100 Participants
|
257 Participants
n=302 Participants
|
|
Marital status
Missing
|
1 Participants
n=102 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=302 Participants
|
|
Smoking
Never
|
66 Participants
n=102 Participants
|
67 Participants
n=100 Participants
|
66 Participants
n=100 Participants
|
199 Participants
n=302 Participants
|
|
Smoking
Past
|
31 Participants
n=102 Participants
|
33 Participants
n=100 Participants
|
32 Participants
n=100 Participants
|
96 Participants
n=302 Participants
|
|
Smoking
Current
|
4 Participants
n=102 Participants
|
0 Participants
n=100 Participants
|
2 Participants
n=100 Participants
|
6 Participants
n=302 Participants
|
|
Smoking
Missing
|
1 Participants
n=102 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=302 Participants
|
|
Alcohol Use
0 drinks / week
|
30 Participants
n=102 Participants
|
31 Participants
n=100 Participants
|
28 Participants
n=100 Participants
|
89 Participants
n=302 Participants
|
|
Alcohol Use
1-6 drinks / week
|
50 Participants
n=102 Participants
|
46 Participants
n=100 Participants
|
53 Participants
n=100 Participants
|
149 Participants
n=302 Participants
|
|
Alcohol Use
≥ 7 drinks / week
|
21 Participants
n=102 Participants
|
23 Participants
n=100 Participants
|
19 Participants
n=100 Participants
|
63 Participants
n=302 Participants
|
|
Alcohol Use
Missing
|
1 Participants
n=102 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=302 Participants
|
|
Menopause Quality of Life Questionnaire total
|
3.3 units on a scale
STANDARD_DEVIATION 1.2 • n=99 Participants • 11 participants have missing data for MENQOL total
|
3.2 units on a scale
STANDARD_DEVIATION 1.1 • n=97 Participants • 11 participants have missing data for MENQOL total
|
3.3 units on a scale
STANDARD_DEVIATION 1.0 • n=95 Participants • 11 participants have missing data for MENQOL total
|
3.3 units on a scale
STANDARD_DEVIATION 1.1 • n=291 Participants • 11 participants have missing data for MENQOL total
|
|
Patient Health Questionnaire 8 depression
None (0-4)
|
69 Participants
n=102 Participants
|
75 Participants
n=100 Participants
|
69 Participants
n=100 Participants
|
213 Participants
n=302 Participants
|
|
Patient Health Questionnaire 8 depression
Mild (5-9)
|
25 Participants
n=102 Participants
|
22 Participants
n=100 Participants
|
23 Participants
n=100 Participants
|
70 Participants
n=302 Participants
|
|
Patient Health Questionnaire 8 depression
Moderate - severe (≥10)
|
7 Participants
n=102 Participants
|
3 Participants
n=100 Participants
|
8 Participants
n=100 Participants
|
18 Participants
n=302 Participants
|
|
Patient Health Questionnaire 8 depression
Missing
|
1 Participants
n=102 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=302 Participants
|
|
Generalized Anxiety Disorder Questionnaire 7
None (0-4)
|
64 Participants
n=102 Participants
|
75 Participants
n=100 Participants
|
64 Participants
n=100 Participants
|
203 Participants
n=302 Participants
|
|
Generalized Anxiety Disorder Questionnaire 7
Mild (5-9)
|
25 Participants
n=102 Participants
|
21 Participants
n=100 Participants
|
24 Participants
n=100 Participants
|
70 Participants
n=302 Participants
|
|
Generalized Anxiety Disorder Questionnaire 7
Moderate - severe (≥10)
|
12 Participants
n=102 Participants
|
4 Participants
n=100 Participants
|
12 Participants
n=100 Participants
|
28 Participants
n=302 Participants
|
|
Generalized Anxiety Disorder Questionnaire 7
Missing
|
1 Participants
n=102 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=302 Participants
|
|
Sexually active
Yes
|
81 Participants
n=102 Participants
|
80 Participants
n=100 Participants
|
84 Participants
n=100 Participants
|
245 Participants
n=302 Participants
|
|
Sexually active
No
|
20 Participants
n=102 Participants
|
20 Participants
n=100 Participants
|
16 Participants
n=100 Participants
|
56 Participants
n=302 Participants
|
|
Sexually active
Missing
|
1 Participants
n=102 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=302 Participants
|
|
Female Sexual Distress Scale-Revised, item 1, distressed about sex life
Never / rarely
|
15 Participants
n=102 Participants
|
12 Participants
n=100 Participants
|
18 Participants
n=100 Participants
|
45 Participants
n=302 Participants
|
|
Female Sexual Distress Scale-Revised, item 1, distressed about sex life
Occasionally
|
33 Participants
n=102 Participants
|
33 Participants
n=100 Participants
|
33 Participants
n=100 Participants
|
99 Participants
n=302 Participants
|
|
Female Sexual Distress Scale-Revised, item 1, distressed about sex life
Frequently / always
|
53 Participants
n=102 Participants
|
54 Participants
n=100 Participants
|
49 Participants
n=100 Participants
|
156 Participants
n=302 Participants
|
|
Female Sexual Distress Scale-Revised, item 1, distressed about sex life
Missing
|
1 Participants
n=102 Participants
|
1 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
2 Participants
n=302 Participants
|
|
Female Sexual Function Index total
|
15.2 units on a scale
STANDARD_DEVIATION 539 • n=81 Participants • 50 participants have missing data on FSFI total
|
15.2 units on a scale
STANDARD_DEVIATION 6.5 • n=86 Participants • 50 participants have missing data on FSFI total
|
16.1 units on a scale
STANDARD_DEVIATION 6.6 • n=85 Participants • 50 participants have missing data on FSFI total
|
15.5 units on a scale
STANDARD_DEVIATION 6.4 • n=252 Participants • 50 participants have missing data on FSFI total
|
|
Vaginal pH
≤ 5
|
18 Participants
n=102 Participants
|
12 Participants
n=100 Participants
|
9 Participants
n=100 Participants
|
39 Participants
n=302 Participants
|
|
Vaginal pH
> 5
|
81 Participants
n=102 Participants
|
87 Participants
n=100 Participants
|
90 Participants
n=100 Participants
|
258 Participants
n=302 Participants
|
|
Vaginal pH
Missing
|
3 Participants
n=102 Participants
|
1 Participants
n=100 Participants
|
1 Participants
n=100 Participants
|
5 Participants
n=302 Participants
|
|
Vaginal maturation index
≤ 5% superficial cells
|
86 Participants
n=102 Participants
|
78 Participants
n=100 Participants
|
81 Participants
n=100 Participants
|
245 Participants
n=302 Participants
|
|
Vaginal maturation index
> 5% superficial cells
|
6 Participants
n=102 Participants
|
11 Participants
n=100 Participants
|
7 Participants
n=100 Participants
|
24 Participants
n=302 Participants
|
|
Vaginal maturation index
Missing
|
10 Participants
n=102 Participants
|
11 Participants
n=100 Participants
|
12 Participants
n=100 Participants
|
33 Participants
n=302 Participants
|
|
Most bothersome symptom
Vulvar and/or vaginal itching
|
10 Participants
n=102 Participants
|
4 Participants
n=100 Participants
|
6 Participants
n=100 Participants
|
20 Participants
n=302 Participants
|
|
Most bothersome symptom
Vulvar and/or vaginal pain
|
5 Participants
n=102 Participants
|
7 Participants
n=100 Participants
|
2 Participants
n=100 Participants
|
14 Participants
n=302 Participants
|
|
Most bothersome symptom
Vaginal dryness
|
23 Participants
n=102 Participants
|
17 Participants
n=100 Participants
|
23 Participants
n=100 Participants
|
63 Participants
n=302 Participants
|
|
Most bothersome symptom
Vulvar and/or vaginal irritation
|
7 Participants
n=102 Participants
|
4 Participants
n=100 Participants
|
8 Participants
n=100 Participants
|
19 Participants
n=302 Participants
|
|
Most bothersome symptom
Pain with vaginal penetration
|
54 Participants
n=102 Participants
|
68 Participants
n=100 Participants
|
60 Participants
n=100 Participants
|
182 Participants
n=302 Participants
|
|
Most bothersome symptom
Missing
|
3 Participants
n=102 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=100 Participants
|
4 Participants
n=302 Participants
|
|
Self-reported health
Excellent
|
26 Participants
n=102 Participants
|
27 Participants
n=100 Participants
|
20 Participants
n=100 Participants
|
73 Participants
n=302 Participants
|
|
Self-reported health
Very good
|
41 Participants
n=102 Participants
|
55 Participants
n=100 Participants
|
47 Participants
n=100 Participants
|
143 Participants
n=302 Participants
|
|
Self-reported health
Good
|
33 Participants
n=102 Participants
|
15 Participants
n=100 Participants
|
30 Participants
n=100 Participants
|
78 Participants
n=302 Participants
|
|
Self-reported health
Fair / poor
|
1 Participants
n=102 Participants
|
3 Participants
n=100 Participants
|
3 Participants
n=100 Participants
|
7 Participants
n=302 Participants
|
|
Self-reported health
Missing
|
1 Participants
n=102 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=302 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4, Week 12Population: Analysis includes participants with MBS data at baseline and either week 4 or 12.
Mean change from baseline to 12 weeks in the severity of the MBS on a scale of 0-3, better to worse.
Outcome measures
| Measure |
Vagifem
n=97 Participants
One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg). One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.
Vagifem® tablets contain 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. The excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Vagifem® comes as a small white film-coated tablet. The coating is made of hypromellose and polyethylene glycol.
A placebo vaginal gel visually identical composed of inert hydroxyethylcellulose gel (pH adjusted) applied every 3 days over entire 12 weeks.
Vagifem: One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.
|
Replens
n=99 Participants
One hundred participants will be randomized into the Replens® 'active' arm. These women will receive a tube containing Replens® vaginal gel. 2.5 gm to be applied vaginally every 3 days over 12 weeks.
Replens® is a bioadhesive polycarbophil-based moisturizing vaginal gel containing; purified water (vehicle humectant), glycerin (moisturizer), mineral oil (as a moisturizer), polycarbophil and carbomer homopolymer type B (allow the product to stick to the vaginal wall), hydrogenated palm oil glyceride (moisturizer), sorbic acid (preservative, antimicrobial), methylparaben, sodium hydroxide (adjusts pH of product so it is suitable for vaginal use).
A placebo vaginal tablet visually identical to Vagifem® is inserted daily for 2 weeks, then 2 days/week for remaining 10 weeks.
Replens: 2.5 gm to be applied vaginally every 3 days over 12 weeks.
Placebo: Dispensed in visually identical bottle and tablet form.
|
Placebo
n=98 Participants
One hundred participants will be randomized into the 'placebo arm' of the study. This arm is comprised of two placebo preparations; placebo vaginal tablet and placebo vaginal gel applied on the same schedule as 'active' arms.
The placebo tablet coating and excipient ingredients will be the same as are used for Vagifem®; the coating is made of hypromellose and polyethylene glycol and the excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate.
Placebo vaginal gel. The product is a inert hydroxyethylcellulose gel (pH adjusted).
Placebo: Dispensed in visually identical bottle and tablet form.
Placebo: Dispensed in visually identical tube and gel form.
|
|---|---|---|---|
|
Most Bothersome Symptom (MBS) Severity
Week 4 minus baseline
|
-1.2 units on a scale
Interval -1.4 to -1.0
|
-1.0 units on a scale
Interval -1.2 to -0.8
|
-0.2 units on a scale
Interval -0.5 to 0.1
|
|
Most Bothersome Symptom (MBS) Severity
Week 12 minus baseline
|
-1.4 units on a scale
Interval -1.6 to -1.2
|
-1.2 units on a scale
Interval -1.4 to -1.0
|
-1.3 units on a scale
Interval -1.5 to -1.1
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 12Population: Analysis includes participants with VSI data at baseline and either week 4 or 12.
Mean change from baseline to 12 weeks in composite Vaginal Symptoms Index (VSI). The VSI is a Modified Bachman scale measuring vulvovaginal itching, dryness, irritation, soreness, and pain with sexual activity among sexually active women, each rated 0=none to 3=severe, and then averaged for a total score of 0-3.
Outcome measures
| Measure |
Vagifem
n=100 Participants
One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg). One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.
Vagifem® tablets contain 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. The excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Vagifem® comes as a small white film-coated tablet. The coating is made of hypromellose and polyethylene glycol.
A placebo vaginal gel visually identical composed of inert hydroxyethylcellulose gel (pH adjusted) applied every 3 days over entire 12 weeks.
Vagifem: One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.
|
Replens
n=99 Participants
One hundred participants will be randomized into the Replens® 'active' arm. These women will receive a tube containing Replens® vaginal gel. 2.5 gm to be applied vaginally every 3 days over 12 weeks.
Replens® is a bioadhesive polycarbophil-based moisturizing vaginal gel containing; purified water (vehicle humectant), glycerin (moisturizer), mineral oil (as a moisturizer), polycarbophil and carbomer homopolymer type B (allow the product to stick to the vaginal wall), hydrogenated palm oil glyceride (moisturizer), sorbic acid (preservative, antimicrobial), methylparaben, sodium hydroxide (adjusts pH of product so it is suitable for vaginal use).
A placebo vaginal tablet visually identical to Vagifem® is inserted daily for 2 weeks, then 2 days/week for remaining 10 weeks.
Replens: 2.5 gm to be applied vaginally every 3 days over 12 weeks.
Placebo: Dispensed in visually identical bottle and tablet form.
|
Placebo
n=99 Participants
One hundred participants will be randomized into the 'placebo arm' of the study. This arm is comprised of two placebo preparations; placebo vaginal tablet and placebo vaginal gel applied on the same schedule as 'active' arms.
The placebo tablet coating and excipient ingredients will be the same as are used for Vagifem®; the coating is made of hypromellose and polyethylene glycol and the excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate.
Placebo vaginal gel. The product is a inert hydroxyethylcellulose gel (pH adjusted).
Placebo: Dispensed in visually identical bottle and tablet form.
Placebo: Dispensed in visually identical tube and gel form.
|
|---|---|---|---|
|
Vaginal Symptoms Index
Week 4 minus baseline
|
-0.7 units on a scale
Interval -0.8 to -0.5
|
-0.5 units on a scale
Interval -0.7 to -0.4
|
-0.6 units on a scale
Interval -0.8 to -0.5
|
|
Vaginal Symptoms Index
Week 12 minus baseline
|
-0.9 units on a scale
Interval -1.1 to -0.8
|
-0.7 units on a scale
Interval -0.9 to -0.6
|
-0.9 units on a scale
Interval -1.0 to -0.7
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 12Female Sexual Function Index (FSFI); Evaluate dyspareunia, sexual function and distress. A composite score from 2 (not sexually active and no desire) to 36 and 6 domains.
Outcome measures
| Measure |
Vagifem
n=70 Participants
One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg). One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.
Vagifem® tablets contain 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. The excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Vagifem® comes as a small white film-coated tablet. The coating is made of hypromellose and polyethylene glycol.
A placebo vaginal gel visually identical composed of inert hydroxyethylcellulose gel (pH adjusted) applied every 3 days over entire 12 weeks.
Vagifem: One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.
|
Replens
n=81 Participants
One hundred participants will be randomized into the Replens® 'active' arm. These women will receive a tube containing Replens® vaginal gel. 2.5 gm to be applied vaginally every 3 days over 12 weeks.
Replens® is a bioadhesive polycarbophil-based moisturizing vaginal gel containing; purified water (vehicle humectant), glycerin (moisturizer), mineral oil (as a moisturizer), polycarbophil and carbomer homopolymer type B (allow the product to stick to the vaginal wall), hydrogenated palm oil glyceride (moisturizer), sorbic acid (preservative, antimicrobial), methylparaben, sodium hydroxide (adjusts pH of product so it is suitable for vaginal use).
A placebo vaginal tablet visually identical to Vagifem® is inserted daily for 2 weeks, then 2 days/week for remaining 10 weeks.
Replens: 2.5 gm to be applied vaginally every 3 days over 12 weeks.
Placebo: Dispensed in visually identical bottle and tablet form.
|
Placebo
n=82 Participants
One hundred participants will be randomized into the 'placebo arm' of the study. This arm is comprised of two placebo preparations; placebo vaginal tablet and placebo vaginal gel applied on the same schedule as 'active' arms.
The placebo tablet coating and excipient ingredients will be the same as are used for Vagifem®; the coating is made of hypromellose and polyethylene glycol and the excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate.
Placebo vaginal gel. The product is a inert hydroxyethylcellulose gel (pH adjusted).
Placebo: Dispensed in visually identical bottle and tablet form.
Placebo: Dispensed in visually identical tube and gel form.
|
|---|---|---|---|
|
Female Sexual Function Index
Week 4 minus baseline
|
3.1 units on a scale
Interval 1.5 to 4.7
|
2.9 units on a scale
Interval 1.7 to 4.1
|
3.2 units on a scale
Interval 1.8 to 4.7
|
|
Female Sexual Function Index
Week 12 minus baseline
|
5.4 units on a scale
Interval 4.0 to 6.9
|
3.1 units on a scale
Interval 1.7 to 4.5
|
4.5 units on a scale
Interval 2.8 to 6.1
|
SECONDARY outcome
Timeframe: Week 12Likert Scale 0 = no to 10 = complete satisfaction.
Outcome measures
| Measure |
Vagifem
n=98 Participants
One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg). One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.
Vagifem® tablets contain 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. The excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Vagifem® comes as a small white film-coated tablet. The coating is made of hypromellose and polyethylene glycol.
A placebo vaginal gel visually identical composed of inert hydroxyethylcellulose gel (pH adjusted) applied every 3 days over entire 12 weeks.
Vagifem: One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.
|
Replens
n=99 Participants
One hundred participants will be randomized into the Replens® 'active' arm. These women will receive a tube containing Replens® vaginal gel. 2.5 gm to be applied vaginally every 3 days over 12 weeks.
Replens® is a bioadhesive polycarbophil-based moisturizing vaginal gel containing; purified water (vehicle humectant), glycerin (moisturizer), mineral oil (as a moisturizer), polycarbophil and carbomer homopolymer type B (allow the product to stick to the vaginal wall), hydrogenated palm oil glyceride (moisturizer), sorbic acid (preservative, antimicrobial), methylparaben, sodium hydroxide (adjusts pH of product so it is suitable for vaginal use).
A placebo vaginal tablet visually identical to Vagifem® is inserted daily for 2 weeks, then 2 days/week for remaining 10 weeks.
Replens: 2.5 gm to be applied vaginally every 3 days over 12 weeks.
Placebo: Dispensed in visually identical bottle and tablet form.
|
Placebo
n=95 Participants
One hundred participants will be randomized into the 'placebo arm' of the study. This arm is comprised of two placebo preparations; placebo vaginal tablet and placebo vaginal gel applied on the same schedule as 'active' arms.
The placebo tablet coating and excipient ingredients will be the same as are used for Vagifem®; the coating is made of hypromellose and polyethylene glycol and the excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate.
Placebo vaginal gel. The product is a inert hydroxyethylcellulose gel (pH adjusted).
Placebo: Dispensed in visually identical bottle and tablet form.
Placebo: Dispensed in visually identical tube and gel form.
|
|---|---|---|---|
|
Treatment Satisfaction
|
8.6 units on a scale
Standard Deviation 2.6
|
7.7 units on a scale
Standard Deviation 3.2
|
8.1 units on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Week 12Patient Benefit Evaluation: Overall, do you believe that you experienced a meaningful benefit from the study medication? (Yes/No).
Outcome measures
| Measure |
Vagifem
n=102 Participants
One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg). One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.
Vagifem® tablets contain 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. The excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Vagifem® comes as a small white film-coated tablet. The coating is made of hypromellose and polyethylene glycol.
A placebo vaginal gel visually identical composed of inert hydroxyethylcellulose gel (pH adjusted) applied every 3 days over entire 12 weeks.
Vagifem: One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.
|
Replens
n=100 Participants
One hundred participants will be randomized into the Replens® 'active' arm. These women will receive a tube containing Replens® vaginal gel. 2.5 gm to be applied vaginally every 3 days over 12 weeks.
Replens® is a bioadhesive polycarbophil-based moisturizing vaginal gel containing; purified water (vehicle humectant), glycerin (moisturizer), mineral oil (as a moisturizer), polycarbophil and carbomer homopolymer type B (allow the product to stick to the vaginal wall), hydrogenated palm oil glyceride (moisturizer), sorbic acid (preservative, antimicrobial), methylparaben, sodium hydroxide (adjusts pH of product so it is suitable for vaginal use).
A placebo vaginal tablet visually identical to Vagifem® is inserted daily for 2 weeks, then 2 days/week for remaining 10 weeks.
Replens: 2.5 gm to be applied vaginally every 3 days over 12 weeks.
Placebo: Dispensed in visually identical bottle and tablet form.
|
Placebo
n=100 Participants
One hundred participants will be randomized into the 'placebo arm' of the study. This arm is comprised of two placebo preparations; placebo vaginal tablet and placebo vaginal gel applied on the same schedule as 'active' arms.
The placebo tablet coating and excipient ingredients will be the same as are used for Vagifem®; the coating is made of hypromellose and polyethylene glycol and the excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate.
Placebo vaginal gel. The product is a inert hydroxyethylcellulose gel (pH adjusted).
Placebo: Dispensed in visually identical bottle and tablet form.
Placebo: Dispensed in visually identical tube and gel form.
|
|---|---|---|---|
|
Patient Benefit Evaluation
Yes
|
79 Participants
|
58 Participants
|
62 Participants
|
|
Patient Benefit Evaluation
No
|
20 Participants
|
41 Participants
|
34 Participants
|
|
Patient Benefit Evaluation
Missing
|
3 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Sample includes 247 participants with pH \> 5 at baseline and non-missing data on pH at week 12
Objective measures of genitourinary atrophy: pH (\<5 or \>5) at week 12
Outcome measures
| Measure |
Vagifem
n=78 Participants
One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg). One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.
Vagifem® tablets contain 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. The excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Vagifem® comes as a small white film-coated tablet. The coating is made of hypromellose and polyethylene glycol.
A placebo vaginal gel visually identical composed of inert hydroxyethylcellulose gel (pH adjusted) applied every 3 days over entire 12 weeks.
Vagifem: One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.
|
Replens
n=85 Participants
One hundred participants will be randomized into the Replens® 'active' arm. These women will receive a tube containing Replens® vaginal gel. 2.5 gm to be applied vaginally every 3 days over 12 weeks.
Replens® is a bioadhesive polycarbophil-based moisturizing vaginal gel containing; purified water (vehicle humectant), glycerin (moisturizer), mineral oil (as a moisturizer), polycarbophil and carbomer homopolymer type B (allow the product to stick to the vaginal wall), hydrogenated palm oil glyceride (moisturizer), sorbic acid (preservative, antimicrobial), methylparaben, sodium hydroxide (adjusts pH of product so it is suitable for vaginal use).
A placebo vaginal tablet visually identical to Vagifem® is inserted daily for 2 weeks, then 2 days/week for remaining 10 weeks.
Replens: 2.5 gm to be applied vaginally every 3 days over 12 weeks.
Placebo: Dispensed in visually identical bottle and tablet form.
|
Placebo
n=84 Participants
One hundred participants will be randomized into the 'placebo arm' of the study. This arm is comprised of two placebo preparations; placebo vaginal tablet and placebo vaginal gel applied on the same schedule as 'active' arms.
The placebo tablet coating and excipient ingredients will be the same as are used for Vagifem®; the coating is made of hypromellose and polyethylene glycol and the excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate.
Placebo vaginal gel. The product is a inert hydroxyethylcellulose gel (pH adjusted).
Placebo: Dispensed in visually identical bottle and tablet form.
Placebo: Dispensed in visually identical tube and gel form.
|
|---|---|---|---|
|
pH
Week 12 pH > 5
|
42 Participants
|
77 Participants
|
74 Participants
|
|
pH
Week 12 pH ≤ 5
|
36 Participants
|
8 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Sample includes 223 participants with VMI ≤ 5% superficial cells at baseline and non-missing VMI data at week 12
Objective Measures of Genitourinary Atrophy: Vaginal Maturation Index (VMI) described by % parabasal, intermediate, and superficial cells (≤ 5% or \>5% superficial cells) at week 12
Outcome measures
| Measure |
Vagifem
n=79 Participants
One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg). One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.
Vagifem® tablets contain 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. The excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Vagifem® comes as a small white film-coated tablet. The coating is made of hypromellose and polyethylene glycol.
A placebo vaginal gel visually identical composed of inert hydroxyethylcellulose gel (pH adjusted) applied every 3 days over entire 12 weeks.
Vagifem: One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.
|
Replens
n=73 Participants
One hundred participants will be randomized into the Replens® 'active' arm. These women will receive a tube containing Replens® vaginal gel. 2.5 gm to be applied vaginally every 3 days over 12 weeks.
Replens® is a bioadhesive polycarbophil-based moisturizing vaginal gel containing; purified water (vehicle humectant), glycerin (moisturizer), mineral oil (as a moisturizer), polycarbophil and carbomer homopolymer type B (allow the product to stick to the vaginal wall), hydrogenated palm oil glyceride (moisturizer), sorbic acid (preservative, antimicrobial), methylparaben, sodium hydroxide (adjusts pH of product so it is suitable for vaginal use).
A placebo vaginal tablet visually identical to Vagifem® is inserted daily for 2 weeks, then 2 days/week for remaining 10 weeks.
Replens: 2.5 gm to be applied vaginally every 3 days over 12 weeks.
Placebo: Dispensed in visually identical bottle and tablet form.
|
Placebo
n=71 Participants
One hundred participants will be randomized into the 'placebo arm' of the study. This arm is comprised of two placebo preparations; placebo vaginal tablet and placebo vaginal gel applied on the same schedule as 'active' arms.
The placebo tablet coating and excipient ingredients will be the same as are used for Vagifem®; the coating is made of hypromellose and polyethylene glycol and the excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate.
Placebo vaginal gel. The product is a inert hydroxyethylcellulose gel (pH adjusted).
Placebo: Dispensed in visually identical bottle and tablet form.
Placebo: Dispensed in visually identical tube and gel form.
|
|---|---|---|---|
|
Vaginal Maturation Index
Week 12 VMI > 5%
|
45 Participants
|
8 Participants
|
8 Participants
|
|
Vaginal Maturation Index
Week 12 VMI ≤ 5%
|
34 Participants
|
65 Participants
|
63 Participants
|
Adverse Events
Vagifem
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Replens
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vagifem
n=99 participants at risk；n=102 participants at risk
One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg). One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.
Vagifem® tablets contain 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. The excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Vagifem® comes as a small white film-coated tablet. The coating is made of hypromellose and polyethylene glycol.
A placebo vaginal gel visually identical composed of inert hydroxyethylcellulose gel (pH adjusted) applied every 3 days over entire 12 weeks.
Vagifem: One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.
|
Replens
n=99 participants at risk；n=100 participants at risk
One hundred participants will be randomized into the Replens® 'active' arm. These women will receive a tube containing Replens® vaginal gel. 2.5 gm to be applied vaginally every 3 days over 12 weeks.
Replens® is a bioadhesive polycarbophil-based moisturizing vaginal gel containing; purified water (vehicle humectant), glycerin (moisturizer), mineral oil (as a moisturizer), polycarbophil and carbomer homopolymer type B (allow the product to stick to the vaginal wall), hydrogenated palm oil glyceride (moisturizer), sorbic acid (preservative, antimicrobial), methylparaben, sodium hydroxide (adjusts pH of product so it is suitable for vaginal use).
A placebo vaginal tablet visually identical to Vagifem® is inserted daily for 2 weeks, then 2 days/week for remaining 10 weeks.
Replens: 2.5 gm to be applied vaginally every 3 days over 12 weeks.
Placebo: Dispensed in visually identical bottle and tablet form.
|
Placebo
n=99 participants at risk；n=100 participants at risk
One hundred participants will be randomized into the 'placebo arm' of the study. This arm is comprised of two placebo preparations; placebo vaginal tablet and placebo vaginal gel applied on the same schedule as 'active' arms.
The placebo tablet coating and excipient ingredients will be the same as are used for Vagifem®; the coating is made of hypromellose and polyethylene glycol and the excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate.
Placebo vaginal gel. The product is a inert hydroxyethylcellulose gel (pH adjusted).
Placebo: Dispensed in visually identical bottle and tablet form.
Placebo: Dispensed in visually identical tube and gel form.
|
|---|---|---|---|
|
Gastrointestinal disorders
Hospitalization for dehydration
|
0.00%
0/102 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
1.0%
1/100 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
0.00%
0/100 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.98%
1/102 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
0.00%
0/100 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
0.00%
0/100 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.98%
1/102 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
0.00%
0/100 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
0.00%
0/100 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
|
Musculoskeletal and connective tissue disorders
Hospitalization for back pain
|
0.00%
0/102 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
0.00%
0/100 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
1.0%
1/100 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
Other adverse events
| Measure |
Vagifem
n=99 participants at risk；n=102 participants at risk
One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg). One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.
Vagifem® tablets contain 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. The excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Vagifem® comes as a small white film-coated tablet. The coating is made of hypromellose and polyethylene glycol.
A placebo vaginal gel visually identical composed of inert hydroxyethylcellulose gel (pH adjusted) applied every 3 days over entire 12 weeks.
Vagifem: One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.
|
Replens
n=99 participants at risk；n=100 participants at risk
One hundred participants will be randomized into the Replens® 'active' arm. These women will receive a tube containing Replens® vaginal gel. 2.5 gm to be applied vaginally every 3 days over 12 weeks.
Replens® is a bioadhesive polycarbophil-based moisturizing vaginal gel containing; purified water (vehicle humectant), glycerin (moisturizer), mineral oil (as a moisturizer), polycarbophil and carbomer homopolymer type B (allow the product to stick to the vaginal wall), hydrogenated palm oil glyceride (moisturizer), sorbic acid (preservative, antimicrobial), methylparaben, sodium hydroxide (adjusts pH of product so it is suitable for vaginal use).
A placebo vaginal tablet visually identical to Vagifem® is inserted daily for 2 weeks, then 2 days/week for remaining 10 weeks.
Replens: 2.5 gm to be applied vaginally every 3 days over 12 weeks.
Placebo: Dispensed in visually identical bottle and tablet form.
|
Placebo
n=99 participants at risk；n=100 participants at risk
One hundred participants will be randomized into the 'placebo arm' of the study. This arm is comprised of two placebo preparations; placebo vaginal tablet and placebo vaginal gel applied on the same schedule as 'active' arms.
The placebo tablet coating and excipient ingredients will be the same as are used for Vagifem®; the coating is made of hypromellose and polyethylene glycol and the excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate.
Placebo vaginal gel. The product is a inert hydroxyethylcellulose gel (pH adjusted).
Placebo: Dispensed in visually identical bottle and tablet form.
Placebo: Dispensed in visually identical tube and gel form.
|
|---|---|---|---|
|
Reproductive system and breast disorders
Increased vaginal secretions
|
15.2%
14/92 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
16.2%
16/99 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
14.6%
14/96 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
|
Reproductive system and breast disorders
Vaginal itching
|
8.0%
6/75 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
7.6%
6/79 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
7.1%
6/84 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
|
Reproductive system and breast disorders
Breast tenderness
|
3.1%
3/97 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
0.00%
0/98 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
2.1%
2/96 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
|
Reproductive system and breast disorders
Vaginal spotting or bleeding
|
0.00%
0/99 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
1.0%
1/99 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
0.00%
0/99 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
|
Skin and subcutaneous tissue disorders
Skin rash outside the vagina
|
4.2%
4/96 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
0.00%
0/97 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
1.0%
1/97 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
|
Skin and subcutaneous tissue disorders
Body rash
|
2.1%
2/95 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
1.0%
1/97 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
5.1%
5/98 • Adverse event data was collected for each participant from randomization through the 12-week visit.
|
Additional Information
Dr. Katherine A. Guthrie
Fred Hutchinson Cancer Research Center
Phone: 2066675595
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place