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  • Title: The HSDD registry for women: a novel patient registry for women with generalized acquired hypoactive sexual desire disorder.
    Author: Rosen RC, Connor MK, Maserejian NN.
    Journal: J Sex Med; 2010 May; 7(5):1747-56. PubMed ID: 20233298.
    Abstract:
    INTRODUCTION: Hypoactive sexual desire disorder (HSDD) is a clinically challenging disorder in women. Little is known about the natural history of the disorder and long-term consequences. A longitudinal registry can address these needs. AIM: To design and implement a registry study of HSDD in women to characterize the natural history of HSDD and current treatment practices. METHODS: A longitudinal multicenter registry study has been initiated at clinical sites across the United States. A total of 1,500 women (approximately 1,000 premenopausal, 500 postmenopausal) with clinically-diagnosed HSDD, confirmed by the Decreased Sexual Desire Screener, will be recruited over 24 months at up to 40 clinical sites. Participants will be followed with in-clinic or remote, computer-assisted follow-up. Data from the initial implementation phase was analyzed to assess feasibility of the protocol. A qualitative substudy (N = 40) was conducted to assess content validity of the participant questionnaire. MAIN OUTCOME MEASURES: The primary outcome measure for the Registry study is a patient-based global impression of change in HSDD. Secondary outcome measures are derived from two sources: (i) self-administered questionnaire completed by the participant, and (ii) medical history review completed by the clinician. The questionnaire includes validated measures of sexual function, quality of life, relationship factors, and physical and mental health, as well as newly developed questions on treatments and medications. RESULTS: As of February 12, 2009, 290 women (209 premenopausal, 81 postmenopausal) had been recruited from 15 clinical sites. Results of the initial implementation phase and qualitative substudy on the participant questionnaire show that the Registry protocol is highly feasible and the questionnaire consisting of previously validated scales and selected new items has high content validity. CONCLUSIONS: As the first longitudinal registry study in female sexual dysfunction, the HSDD Registry will contribute to a broader understanding of the impact and treatment needs of women with clinically diagnosed HSDD.
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