Symptoms and associated impact in pre- and postmenopausal women with sexual arousal disorder: a concept elicitation study

Abstract

Background Approximately 26% of adult women in the United States suffer from female sexual arousal disorder (FSAD), yet little has been done to compare the experience of FSAD in pre- and postmenopausal women, which is critical to enhance the current understanding of FSAD and inform the development and assessment of treatment options for these patient populations. Aim To explore the experience of condition-associated symptoms and the relative importance of FSAD symptoms, including their severity, bother, and impact, on participants’ health-related quality of life (HRQoL) in pre- and postmenopausal women with FSAD. Methods In-depth, qualitative, semistructured concept elicitation interviews were conducted with premenopausal (n = 23) and postmenopausal (n = 13) women who were clinically diagnosed with FSAD by a trained sexual medicine clinician. All interviews were audio recorded and transcribed verbatim by a professional transcription company. Thematic analysis was performed with the assistance of NVivo qualitative analysis software. Outcomes Outcomes included qualitative interview data about FSAD symptoms and HRQoL, as well as a comparison between pre- and postmenopausal populations. Results The most frequently reported symptom in both cohorts was “inability or difficulty with orgasm” (premenopausal, n = 21; postmenopausal, n = 13). The symptom that premenopausal women most desired to have treated was lubrication, and for postmenopausal women, it was a lack of lubrication or wetness and loss of feeling/sensation. In total, 21 of 23 premenopausal women and all 13 postmenopausal women reported a lack of feeling or sensation in the genitals. The most frequently reported HRQoL impact in both groups was decreased confidence. Clinical Implications Results from this study suggest that the manifestation and experience of FSAD are similar in pre- and postmenopausal women and that the unmet need for an FSAD treatment in the postmenopausal population is just as great as that of the premenopausal population. Strengths and Limitations This study involved in-depth qualitative interviews with a relatively small group of women (N = 36) recruited from only 5 study sites across the United States. Conclusion The analysis of qualitative data from the concept elicitation interviews revealed a substantial physical and emotional burden of FSAD, underscoring the need for Food and Drug Administration–approved treatment options for pre- and postmenopausal women with FSAD.

Preliminary Efficacy of Topical Sildenafil Cream for the Treatment of Female Sexual Arousal Disorder

“…Although the subset population of women randomized to sildenafil cream with either female sexual arousal disorder only or female sexual arousal disorder with concomitant decreased desire did not demonstrate statistically significant decreased sexual distress as measured by the coprimary endpoint of FSDS-DAO question 14 ( P =.95, Table 3 ), which assesses concern about difficulties with sexual arousal, we found that several other FSDS-DAO questions, which asked about generalized feelings related to sexual distress and interpersonal difficulties, showed significant improvement with sildenafil cream compared with placebo cream (questions 3, 5 and 10, all P ≤.04, Table 3 ) in this exploratory subset. The total FSDS-DAO score decreased by about 7 points for sildenafil cream users in the subset population (a clinically meaningful decrease in sexual distress 11 ) compared with a 2-point decrease for placebo cream users ( P =.10).…”

“…Before the start of the study, we conducted a qualitative content validity study among women with female sexual arousal disorder to ensure that the efficacy endpoints, which were patient-reported outcome measures, were fit for purpose and valid for this specific population. 11 …”

“…Before the start of the study, we conducted a qualitative content validity study among women with female sexual arousal disorder to ensure that the efficacy endpoints, which were patient-reported outcome measures, were fit for purpose and valid for this specific population. 11 This clinical trial was conducted at 49 sites in the United States, approved by the Advarra IRB (Pro00049161), and registered at ClinicalTrials.gov (NCT04948151). Healthy premenopausal women aged 18 years or older and their sexual partners were screened for the study.…”

Sexuality in Postmenopausal Women with Genital Prolapse

“…Female sexual dysfunction is defined as a disorder, at any stage of the sexual response, that is capable of generating personal stress and having a negative impact on quality of life and interpersonal relationships [3]. Their etiologies are multifactorial and their actual incidence is currently unknown [12]. They are often a taboo subject in our society at different levels and, unsurprisingly, also during clinical interviews [13], which makes self-completion questionnaires such as the FSM an emerging tool to facilitate diagnosis, as they facilitate data collection by allowing the patient to fill them in privately and anonymously [14].…”

Female Sexual Arousal Disorder

“…If positive, it could lead to a new therapeutic area for the unmet treatment needs of premenopausal and postmenopausal women with female sexual arousal disorder. 6,7…”