PMID- 23057791
OWN - NLM
STAT- MEDLINE
DCOM- 20130524
LR  - 20220410
IS  - 1743-6109 (Electronic)
IS  - 1743-6095 (Linking)
VI  - 9
IP  - 12
DP  - 2012 Dec
TI  - Open-label extension study of flibanserin in women with hypoactive sexual desire 
      disorder.
PG  - 3180-8
LID - 10.1111/j.1743-6109.2012.02942.x [doi]
AB  - INTRODUCTION: Hypoactive Sexual Desire Disorder (HSDD) is a common form of Female 
      Sexual Dysfunction characterized by low sexual desire that causes distress or 
      interpersonal difficulty. AIM: This 52-week open-label extension study aimed to 
      assess the safety and tolerability of flibanserin, a postsynaptic 5-HT(1A) 
      agonist/5-HT(2A) antagonist, in women with HSDD. METHODS: Women with HSDD who had 
      completed a trial of flibanserin or flibanserin placebo received flexible-dose 
      flibanserin (50 or 100 mg once daily at bedtime [qhs] or 25 or 50 mg twice daily 
      [bid]) for 52 weeks. MAIN OUTCOME MEASURES: Primary end points were: proportions 
      of women with somnolence, sedation, fatigue, dizziness, nausea, and vomiting 
      (adverse events [AEs] known to be associated with flibanserin); discontinuations 
      due to AEs; and serious AEs. Secondary end points included change from baseline 
      in Female Sexual Distress Scale-Revised total and Item 13 scores and Female 
      Sexual Function Index (FSFI) total and desire domain score scores. FSFI total 
      scores were used to classify women into FSFI remitters (FSFI score >26.55, 
      indicating no clinical sexual dysfunction) and FSFI non-remitters (FSFI score 
      <26.55). RESULTS: Of the 1723 women who received flibanserin, 962 (55.8%) 
      completed 12 months' treatment, and 883 women were exposed to flibanserin 100 mg 
      qhs for >/=180 days. Somnolence, sedation, fatigue, dizziness, nausea, and vomiting 
      were reported by 15.8, 1.6, 7.6, 6.9, 6.3, and 1.4% of participants, 
      respectively. A total of 185 participants (10.7%) discontinued due to AEs. 
      Serious AEs were reported by 1.2% of participants. At study end, 42% of baseline 
      non-remitters had improved their FSFI score to remission level. The proportion of 
      baseline FSFI remitters in remission rose from 83% at week 4 to a stable value of 
       approximately 90%. CONCLUSION: Flibanserin was well tolerated. Sexual function improved in 
      women who were not FSFI remitters at baseline, and was maintained in those who 
      were remitters at baseline.
CI  - (c) 2012 International Society for Sexual Medicine.
FAU - Jayne, Christopher
AU  - Jayne C
AD  - Scott Department of Urology, Baylor College of Medicine, Houston, TX 77030, USA. 
      chrisjayne41@yahoo.com
FAU - Simon, James A
AU  - Simon JA
FAU - Taylor, Leslie V
AU  - Taylor LV
FAU - Kimura, Toshio
AU  - Kimura T
FAU - Lesko, Lynna M
AU  - Lesko LM
CN  - SUNFLOWER study investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT00441558
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20121011
PL  - Netherlands
TA  - J Sex Med
JT  - The journal of sexual medicine
JID - 101230693
RN  - 0 (Benzimidazoles)
RN  - 0 (Serotonin Agents)
RN  - 37JK4STR6Z (flibanserin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Benzimidazoles/*administration & dosage/*adverse effects
MH  - Dizziness/chemically induced
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Schedule
MH  - Fatigue/chemically induced
MH  - Female
MH  - Humans
MH  - Middle Aged
MH  - Nausea/chemically induced
MH  - Serotonin Agents/*administration & dosage/*adverse effects
MH  - Sexual Dysfunctions, Psychological/*drug therapy
MH  - Vomiting/chemically induced
MH  - Young Adult
EDAT- 2012/10/13 06:00
MHDA- 2013/05/28 06:00
CRDT- 2012/10/13 06:00
PHST- 2012/10/13 06:00 [entrez]
PHST- 2012/10/13 06:00 [pubmed]
PHST- 2013/05/28 06:00 [medline]
AID - S1743-6095(15)33815-7 [pii]
AID - 10.1111/j.1743-6109.2012.02942.x [doi]
PST - ppublish
SO  - J Sex Med. 2012 Dec;9(12):3180-8. doi: 10.1111/j.1743-6109.2012.02942.x. Epub 
      2012 Oct 11.