Implementing a successful clinical development program for female sexual dysfunctions (aka how to navigate a regulatory minefield)

Maturitas

Volumn 69, Issue 2, 2011, Pages 97-98

  Simon, James A ^a,b  

^a GEORGE WASHINGTON UNIVERSITY   (United States)

^b Women's Health and Research Consultants   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMFEBUTAMONE PLUS NALTREXONE; FLIBANSERIN; LORCASERIN; PHENTERMINE PLUS TOPIRAMATE; ROFECOXIB; SIBUTRAMINE; SILDENAFIL; TADALAFIL; TESTOSTERONE; VARDENAFIL;

CLINICAL DEVELOPMENT PLAN; DRUG APPROVAL; DRUG CONTROL; DRUG COST; DRUG EFFICACY; DRUG INDUSTRY; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG SAFETY; EDITORIAL; FEMALE; FEMALE SEXUAL DYSFUNCTION; GOVERNMENT; HEALTH CARE COST; HEALTH CARE POLICY; HEALTH INSURANCE; HUMAN; HYPOACTIVE SEXUAL DESIRE DISORDER; LIBIDO; PLACEBO EFFECT; PREMENOPAUSE; RISK BENEFIT ANALYSIS; SEXUAL AROUSAL; SEXUAL HEALTH; SEXUAL INTERCOURSE; SEXUAL SATISFACTION; SUICIDE; TREATMENT OUTCOME; UNITED STATES; WEIGHT REDUCTION; WOMEN'S HEALTH;

DRUG APPROVAL; FEMALE; GOVERNMENT REGULATION; HUMANS; SEXUAL DYSFUNCTION, PHYSIOLOGICAL; SEXUAL DYSFUNCTIONS, PSYCHOLOGICAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 79955962690     PISSN: 03785122     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.maturitas.2011.03.014     Document Type: Editorial

References (6)

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2. Nachtigall L, Casson P, Lucas J, Schofield V, Melson C, Simon JA. Safety and tolerability of testosterone patch therapy for up to 4 years in surgically menopausal women receiving oral or transdermal oestrogen. Gynecol Endocrinol 2011;27(January (1)):39-48.
3. Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA 1999;281:537-44.
4. Shifren JL, Monz BU, Russo PA, Segreti A, Johannes CB. Sexual problems and distress in United States women: prevalence and correlates. Obstet Gynecol 2008;112:970-8.
5. Sand M, Fisher WA. Women's endorsement of models of female sexual response: the nurses' sexuality study. J Sex Med 2007;4(3):708-19.
6. Jordan R, Hallam TJ, Molinoff P, Spana C. Developing treatments for female sexual dysfunction. Clin Pharmacol Ther 2011;89(January (1)):137-41.