Introduction

The Food and Drug Administration (FDA) recommends using patient-reported outcomes (PROs) to evaluate treatments for low sexual interest and arousal in women. PROs are questionnaires that measure symptoms and treatment effects based on what participants report. The FDA suggests recording these frequently to avoid inaccuracies due to memory issues. Shorter recall periods, like 24-hour diaries, may capture more accurate details but can become tiring for participants, reducing their willingness to complete the study. Longer recall periods, such as monthly reports, are easier to complete but one’s memory of their experience may be influenced by unrelated events or recent experiences.

This study compared two methods, 1-month recall and 24-hour recall, to see if the length of the recall period affected the results when assessing the effectiveness of sildenafil cream as a treatment for female sexual arousal disorder (FSAD).

Methods

This study took place at 49 sites across the U.S. Healthy premenopausal women with FSAD symptoms and their sexual partners (if applicable) were screened and gave consent to participate. The authors of the study used two ways to measure treatment outcomes: 1-month recall and 24-hour recall questionnaires.

Participants were divided into two groups: the Evaluation of Recall Subset (ERS) and the non-ERS (control) group. ERS participants completed only 1-month recall questionnaires, while the non-ERS group also used a daily electronic diary (eDiary) to report 24-hour recall data. The study aimed to see if using the eDiary influenced how participants answered the 1-month recall questions and to compare results between the two methods.

During the trial, all participants had a no-drug run-in period, followed by a single-blind placebo period (during which all participants used a placebo cream), and were then randomized to receive either sildenafil cream or a placebo cream for 3 months. The cream was applied before sexual activity, with participants reporting arousal sensations like warmth and tingling.

Results

A total of 833 women volunteered for this study, and 277 were eligible to continue. Of these, 37 women were randomly selected to be part of the ERS group, who completed PROs through the 1-month recall instruments but did not use the 24-hour recall eDiaries. The remaining 240 participants were part of the non-ERS group and used the eDiaries daily. After a screening and placebo period, 200 participants were randomly assigned to either sildenafil cream (101 women) or a placebo cream (99 women) and took part in the main 3-month study.

The study found no major differences between the ERS and non-ERS groups in their responses during the screening periods or after using the sildenafil or placebo cream. Both groups had similar scores on monthly questionnaires measuring arousal sensation and sexual distress. During the 3-month period, participants’ monthly scores on arousal sensation were consistent with the daily eDiary results, showing that the different recall methods aligned well. Overall, the sildenafil cream did not produce significantly different results compared to the placebo cream in either group. The ERS participants were slightly younger than the non-ERS participants, but this did not affect the study outcomes.

Discussion & Conclusion

The results of this study showed that both groups, the women who used daily diaries and those who didn’t, had similar scores on the monthly questionnaires. The strong correlation between daily and monthly recall scores suggests that using the 1-month recall method is still accurate and less burdensome for participants.

Given that daily diaries didn’t significantly change the results, the researchers recommend using only the 1-month recall for future studies to reduce participant fatigue. This suggests that the 1-month recall method is reliable and can be used to evaluate treatment outcomes without adding unnecessary daily assessments. However, since the study only tested this specific daily diary, it’s unclear if other daily diary formats would produce different results.

References:

• Johnson, I., Thurman, A. R., Cornell, K. A., Symonds, T., Hatheway, J., Friend, D. R., & Goldstein, A. (2024). Comparisons and correlations of 1-month recall vs 24-hour recall in patient-reported outcomes of an exploratory, phase 2b, randomized, double-blind, placebo-controlled clinical trial of sildenafil cream, 3.6% for the treatment of female sexual arousal disorder. The Journal of Sexual Medicine, 21(9), 787–792. https://doi.org/10.1093/jsxmed/qdae086