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Table 3 Summary of studies

From: Management of sexual dysfunction in breast cancer survivors: a systematic review

Vaginal products interventions
Reference Study design Participantsa Intervention description Intervention frequency Outcome measures
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
  1. aAll studies required history of breast cancer; post menopause or ≥ 6 months of amenorrhea; genitourinary symptoms; and completion of primary cancer treatment for study participation