TY - JOUR
T1 - Standards for Clinical Trials in Male and Female Sexual Dysfunction
T2 - IV. Unique Aspects of Clinical Trials in Female Sexual Dysfunction
AU - Fisher, William A.
AU - Gruenwald, Ilan
AU - Jannini, Emmanuele A.
AU - Lev-Sagie, Ahinoam
AU - Lowenstein, Lior
AU - Pyke, Robert E.
AU - Reisman, Yakov
AU - Revicki, Dennis A.
AU - Rubio-Aurioles, Eusebio
N1 - Publisher Copyright:
© 2016 International Society for Sexual Medicine
PY - 2017/1/1
Y1 - 2017/1/1
N2 - The focus of this article, the fourth in the series, Standards for Clinical Trials in Male and Female Sexual Dysfunction, is on aspects of clinical trial design and measurement that are specific to clinical trials for treatments of female sexual dysfunction. Challenges in this area include the limited extent of treatment development and clinical trial research across the spectrum of female sexual dysfunctions, changing regulatory considerations, changing diagnostic criteria for female sexual dysfunction, and the need to articulate assessment procedures to these changes. Discussion focuses on approaches to addressing these challenges in clinical trials in female sexual dysfunction.
AB - The focus of this article, the fourth in the series, Standards for Clinical Trials in Male and Female Sexual Dysfunction, is on aspects of clinical trial design and measurement that are specific to clinical trials for treatments of female sexual dysfunction. Challenges in this area include the limited extent of treatment development and clinical trial research across the spectrum of female sexual dysfunctions, changing regulatory considerations, changing diagnostic criteria for female sexual dysfunction, and the need to articulate assessment procedures to these changes. Discussion focuses on approaches to addressing these challenges in clinical trials in female sexual dysfunction.
KW - Clinical Trials
KW - Female Sexual Dysfunction
KW - Standards
UR - http://www.scopus.com/inward/record.url?scp=85021859059&partnerID=8YFLogxK
U2 - 10.1016/j.jsxm.2016.09.022
DO - 10.1016/j.jsxm.2016.09.022
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C2 - 28065357
AN - SCOPUS:85021859059
SN - 1743-6095
VL - 14
SP - 19
EP - 26
JO - Journal of Sexual Medicine
JF - Journal of Sexual Medicine
IS - 1
ER -