Table 3 Summary of studies

Biglia (2010) [24]

Prospective cohort study

• Sample size = 31

Two groups:

12-week intervention:

1. Vaginal Symptoms Score

• Mean age 54.1 in estrogen groups; 46.1 in polycarbophil-based moisturizer group

1. Estriol cream 0.25 mg (Angelini®) or micronized estradiol tablet 12.5 mcg (Vagifem®)

• Product twice weekly

2. Profile of Female Sexual Function

3. Vaginal Health Index

2. Polycarbophil-based moisturizer 2.5 g (Replens®)

Dahir (2014) [27]

Prospective cohort study

• Sample size = 13

One group:

4-week intervention:

1. Sexual function (FSFI)

• Mean age 59.7

1. Vaginal compounded testosterone 300 mcg in 0.5 mL

• Daily for 4 weeks

• Aromatase inhibitor treatment

Donders (2014) [32]

Prospective cohort study

• Sample size = 16

One group:

12-week intervention:

1. Serum estradiol, estrone

• Mean age 57.0, range 52-63

1. Tablet with 0.03 mg estriol and L. acidophilus (Gynoflor®)

• Daily for 4 weeks, then 3 times weekly for 8 weeks

• Aromatase inhibitor treatment

2. Serum estriol

3. Vaginal symptoms

4. Vaginal pH

5. Vaginal maturation index

6. Serum FSH

7. Serum LH

Gelfand (1994) [25]

Prospective cohort study

• Sample size = 25

One group:

12-week intervention:

1. Vaginal health index

• Mean age 60.1, range 43-78

1. Polycarbophil-based moisturizer 2.5 g (Replens®)

• Moisturizer three times weekly

2. Vaginal pH

3. Patient-reported sexual effects

Juraskova (2013) [26]

Prospective cohort study

• Sample size = 25

One group:

26-week intervention:

1. Dyspareunia

• Mean age = 51, range 37-66

1. Polycarbophil-based moisturizer 2.5 g (Replens®); Pelvic floor muscle relaxation; and Organic olive oil

• Moisturizer three times weekly

2. Sexual Activity Questionnaire

• In a sexual relationship

• Pelvic floor muscle relaxation twice daily

3. Sexual satisfaction (FSFI subscale)

• Olive oil use with intercourse

4. Endocrine symptoms (FACT-ES)

5. Satisfaction and acceptability

Kendall (2006) [31]

Prospective cohort study

• Sample size = 6

One group:

12-week intervention:

1. Atrophic vaginitis symptoms

• Mean age = 52, range 51-59

1. Micronized estradiol 25 mcg (Vagifem®)

• Daily for 2 weeks then twice weekly

2. Serum estradiol

• Aromatase inhibitor treatment

3. Serum FSH

4. Serum LH

Lee (2011) [29]

Randomized controlled trial

• Sample size = 98

Two groups:

12-week intervention:

1. Dryness with pain

• Mean age 45.9, range 34-53 in intervention group; 45.0, range 37-53 in placebo group

1. pH-balanced lactic acid gel (pH 4.0)

• Gel three times weekly

2. Dyspareunia

• Double blind

2. Placebo gel (pH 7.2)

3. Vaginal health index

• Placebo control

4. Vaginal pH

• Pre-menopause status prior to breast cancer diagnosis

5. Vaginal maturation index

Loprinzi (1997) [23]

Randomized controlled trial

• Sample size = 52

Two groups:

9-week intervention:

1. Product preference

• Age ≤ 45 = 22 %

1. Polycarbophil-based moisturizer 2.5 g (Replens®), then

• First product: daily x 5 days, three times weekly x 23 days

2. Vaginal dryness

Age 46-55 = 38 %

3. Dyspareunia

• Double blind

• Cross-over

Age ≥ 56 = 40 %

Placebo (Hydroxymethylcellulose, glycerine-delta lactone, hydrogenated palm oil glyceride, water)

• 1 week washout

4. Itching

• Second product: daily x 5 days, three times weekly x 23 days

2. Placebo, then Replens®

Pfeiler (2011) [30]

Prospective cohort study

• Sample size = 10

One group:

2-week intervention:

1. Vaginal dryness

• Mean age 65, range 50-77

1. Estriol 0.5 mg vaginal tablet

• Daily for 2 weeks

2. Dyspareunia

3. Serum estradiol

• Aromatase inhibitor treatment

4. Serum FSH

5. Serum LH

Wills (2012) [33]

Cross-sectional study

• Sample size = 48

Three groups:

Ongoing interventions:

1. Serum estradiol

• Mean age 60, range 49-67 in vaginal estrogen groups; 68, range 53-79 in control group

1. 25 mcg estradiol tablet (Vagifem®)

1. Twice weekly ongoing

2. Vaginal estrogen ring (Estring®)

2. Every 90 days ongoing

3. Control: no vaginal estrogen

3. No vaginal estrogen

• Aromatase inhibitor or SERM treatment

Witherby (2011) [28]

Prospective cohort study

• Sample size = 21

Two groups:

4-week intervention:

1. Serum estradiol

• Mean age 57, range 47-66 in 150 mcg group; 56, range 45-69 in 300 mcg group

1. Vaginal compounded testosterone 150 mcg in 1 g cream

• Daily for 4 weeks

2. Vaginal atrophy symptom

3. Vaginal pH

4. Vaginal maturation index

• Aromatase inhibitor treatment

2. Vaginal compounded testosterone 300 mcg in 1 g cream