Table 2.
| n | Mean Total Scores | Desire ab | Sexual Arousal | Lubrication 1 | Orgasm | Satisfaction cd | Discomfort and Pain | Frequency of Intercourse | Degree of Clitoral Sensation | |
|---|---|---|---|---|---|---|---|---|---|---|
| Ito et al. RCT (2001) 4 | ||||||||||
| ArginMax | 34 | NR | 70.6% a
61.8% b |
NR | 52.9% | 47.1% | 73.5% c 61.8% d |
38.2% | 64.7% | 52.9% |
| Placebo | 43 | NR | 41.9% a
34.9% b |
NR | 25.6% | 30.2% | 37.2% c 34.9% d |
18.6% | 25.6% | 34.9% |
|
p < 0.01 a p = NR b |
NR | p < 0.01 | p < 0.07 |
p < 0.01 c p < 0.01 d |
p < 0.03 | p < 0.01 | p < 0.06 | |||
| Ito et al. RCT (2006) 3 | ||||||||||
| ArginMax Premenopausal | 25 | NR | 72% a 60% b |
NR | 40% | 44% | 68% c 52% d |
32% | 56% | 52% |
| Placebo Premenopausal | 34 | NR | 47% a 38% b |
NR | 29% | 29% | 35% c 35% d |
24% | 26% | 38% |
|
p = 0.03 a p = 0.05 b |
NR | p = 0.20 | p = 0.13 |
p = 0.007 c p = 0.10 d |
p = 0.23 | p = 0.01 | p = 0.15 | |||
| ArginMax Perimenopausal | 14 | NR | 57% a 57% b |
NR | 64% | 50% | 71% c 79% d |
43% | 86% | 71% |
| Placebo Perimenopausal | 6 | NR | 50% a 33% b |
NR | 17% | 17% | 33% c 33% d |
17% | 17% | 33% |
|
p = 0.38 a p = 0.18 b |
NR | p = 0.03 | p = 0.10 |
p = 0.06 c p = 0.03 d |
p = 0.16 | p = 0.002 | p = 0.06 | |||
| ArginMax Postmenopausal | 16 | NR | 50% a 31% b |
NR | 25% | 31% | 44% c 50% d |
19% | 38% | 38% |
| Placebo Postmenopausal | 13 | NR | 8% a 23% b |
NR | 15% | 31% | 31% c 31% d |
15% | 31% | 15% |
|
p = 0.008 a p = 0.33 b |
NR | p = 0.29 | p = 0.50 |
p = 0.25 c p = 0.16 d |
p = 0.43 | p = 0.36 | p = 0.11 | |||
| Bottari et al. RCT (2012) | ||||||||||
| LP Baseline | 40 | 44.6 ± 24.1 | 5.13 ± 2.3 a | 9.2 ± 4.5 | 11.4 ± 5.8 | 6.5 ± 4.1 | 6.1 ± 3.9 c | 6.3 ± 3.5 | NR | NR |
| LP 4 weeks | 40 | 70.9 ± 18.5 (p < 0.05) | 6.6 ± 2.1 a | 14.0 ± 4.5 | 16.0 ± 4.3 | 11.3 ± 2.9 | 11.3 ± 2.9 c | 11.7 ± 1.7 | NR | NR |
| LP 8 weeks | 40 | 71.7 ± 23.9 (p < 0.05) | 7.0 ± 2.4 a | 14.5 ± 4.5 | 16.6 ± 5.2 | 11.1 ± 3.5 | 11.1 ± 3.5 c | 11.4 ± 3.7 | NR | NR |
| Placebo Baseline | 40 | 44.1 ± 22.8 | 5.2 ± 2.4 a | 9.2 ± 4.9 | 10.9 ± 5.1 | 6.4 ± 3.6 | 6.0 ± 3.4 c | 6.4 ± 3.4 | NR | NR |
| Placebo 4 weeks | 40 | 45.0 ± 21.4 | 5.0 ± 2.4 a | 9.3 ± 4.5 | 11.2 ± 4.5 | 6.7± 4.0 | 6.0 ± 3.7 c | 6.8 ± 3.3 | NR | NR |
| Placebo 8 weeks | 40 | 47.4 ± 21.8 | 5.7 ± 2.4 a | 11.3 ± 4.7 | 10.7 ± 4.4 | 6.6 ± 3.6 | 6.0 ± 3.7 c | 7.1 ± 3.4 | NR | NR |
| Bottari et al. NRCT (2013) 2 | ||||||||||
| LP Baseline | 49 | 14.96 ± 2.68 | 2.0 a 2.0 b |
NR | 1.0 | 2.0 | 2.0 c 1.0 d |
1.0 | 1.0 | 2.0 |
| LP 4 weeks | 49 | 28.26 ± 2.35 (p = NR) | 3.0 a 3.0 b |
NR | 3.0 | 3.0 | 3.0 c 3.0 d |
3.0 | 3.0 | 3.0 |
| LP 8 weeks | 49 | 33.91 ± 2.7 (p < 0.001) | 4.0 a 4.0 b |
NR | 4.0 | 4.0 | 4.0 c 4.0 d |
4.0 | 4.0 | 4.0 |
| BM Baseline | 51 | 17.92 ± 2.32 | 2.0 a 3.0 b |
NR | 1.0 | 2.0 | 2.0 c 2.0 d |
2.0 | 1.0 | 2.0 |
| BM 4 weeks | 51 | 23.45 ± 1.82 | 3.0 a 4.0 b |
NR | 2.0 | 3.0 | 2.0 c 3.0 d |
2.0 | 2.0 | 2.0 |
| BM 8 weeks | 51 | 23.52 ± 2.2 | 3.0 a 3.5 b |
NR | 3.0 | 3.0 | 2.0 c 3.0 d |
2.0 | 2.0 | 2.0 |
| Stanislavov et al. RCT (2014) | ||||||||||
| LP Baseline | 40 | 16.50 (SD 2.85) | 2.58 (SD 0.43) | 2.85 (SD 0.59) | 2.85 (SD 0.59) | 2.85 (SD 0.59) | 2.85 (SD 0.59) | 2.52 (SD 0.53) | NR | NR |
| LP 1 month | 40 | 21.65 (SD 2.79) (p < 0.001) |
3.50 (SD 0.54) 58% (p < 0.001) |
3.72 (SD 0.53) 62% (p < 0.001) |
3.72 (SD 0.53) 62% (p < 0.001) |
3.69 (SD 0.57) 62% (p < 0.001) |
3.63 (SD 0.64) 61% (p < 0.001) |
3.39 (SD 0.54) 57% (p < 0.001) |
NR | NR |
| LP 2 months | 40 | 26.49 (SD 3.28) (p < 0.001) |
4.23 (SD 0.66) 71% (p < 0.001) |
4.47 (SD 0.62) 75% (p < 0.001) |
4.53 (SD 0.62) 76% (p < 0.001) |
4.46 (SD 0.64) 74% (p < 0.001) |
4.47 (SD 0.61) 75% (p < 0.001) |
4.32 (SD 0.65) 72% (p < 0.001) |
NR | NR |
| Placebo Baseline | 40 | 12.42 (SD 2.25) | 2.13 (SD 0.51) | 2.13 (SD 0.51) | 2.13 (SD 0.51) | 2.13 (SD 0.51) | 2.13 (SD 0.51) | 1.77 (SD 0.61) | NR | NR |
| Placebo 1 month | 40 | 14.40 (SD 0.82) | 2.13 (SD 0.51) 36% | 2.40 (SD 0.00) 40% | 2.40 (SD 0.00) 40% | 2.40 (SD 0.00) 40% | 2.40 (SD 0.00) 40% | 2.67 (SD 0.51) 45% | NR | NR |
| Placebo 2 months | 40 | 16.62 (SD 2.30) | 2.67 (SD 0.51) 45% | 2.67 (SD 0.51) 45% | 2.76 (SD 0.56) 46% | 2.73 (SD 0.54) 46% | 2.73 (SD 0.54) 46% | 3.06 (SD 0.60) 51% | NR | NR |
| Cesarone et al. NRCT study (2019) | ||||||||||
| Premenopausal LP vs. BM | LP: 34 BM: 33 |
NR | p < 0.05 | p < 0.05 | p < 0.05 | p < 0.05 | p < 0.05 | p < 0.05 | NR | NR |
| Post-menopausal LP vs. BM | LP: 38 BM: 35 |
NR | p < 0.05 | p < 0.05 | p < 0.05 | p < 0.05 | p < 0.05 | p < 0.05 | NR | NR |
Meston et al. (2002) is not included in this table as this study did not measure FSFI. Abbreviations: BM: Best management; FSFI: Female Sexual Function Index; LP: Lady Prelox; NR: Not reported; NRCT: nonrandomized controlled trial; RCT: randomized controlled trial. 1 Lubrication reported as frequency of dryness. 2 Categories reported as median values. 3 Reported as % improved. 4 p-values were not reported. a Level of desire. b Feelings of sexual desire. c Overall sexual satisfaction. d Satisfaction with sexual partner.