PMID- 29502984
OWN - NLM
STAT- MEDLINE
DCOM- 20190930
LR  - 20190930
IS  - 1743-6109 (Electronic)
IS  - 1743-6095 (Linking)
VI  - 15
IP  - 3
DP  - 2018 Mar
TI  - Flibanserin for Hypoactive Sexual Desire Disorder: An Open-Label Safety Study.
PG  - 387-395
LID - S1743-6095(18)30006-7 [pii]
LID - 10.1016/j.jsxm.2017.12.016 [doi]
AB  - BACKGROUND: To evaluate the safety of flibanserin in premenopausal and naturally 
      postmenopausal women with hypoactive sexual desire disorder (HSDD) in an 
      open-label extension (OLE) study. AIM: To examine the safety and tolerability of 
      flibanserin 100 mg once daily at bedtime in the treatment of premenopausal and 
      naturally postmenopausal women with HSDD in a multicenter 28-week OLE study. 
      METHODS: Patients entering this study received flibanserin or placebo in the 
      double-blinded, placebo-controlled trials of premenopausal and postmenopausal 
      women and in a pharmacokinetic study of postmenopausal women. OUTCOMES: The 
      primary end point of this OLE study was the incidence of adverse events (AEs). 
      Secondary exploratory efficacy measures included the Female Sexual Distress 
      Scale-Revised (FSDS-R) total score and FSDS-R item 13 (distress owing to low 
      desire) score and the Female Sexual Function Index (FSFI) total score. Because 
      the sponsor terminated the study early at discontinuation of the development of 
      flibanserin, only descriptive statistics were calculated. RESULTS: Of the 595 
      patients receiving study medication, 346 and 249 patients were premenopausal and 
      postmenopausal, respectively. The mean number of days of exposure to flibanserin 
      was 72.8 (SD = 41.6). AEs were reported by 352 patients (59.2%), and most AEs 
      (93.8%) were mild or moderate. The most common AEs (>/=5%) were dizziness (9.6%), 
      somnolence (8.6%), insomnia (6.2%), and nausea (5.7%). There were no 
      flibanserin-related serious AEs and no instances of suicidal ideation. The safety 
      profile of flibanserin was similar for premenopausal and postmenopausal women. 
      The FSDS-R total scores and FSDS-R item 13 scores were numerically lower at weeks 
      4, 12, and 20 than at baseline (decrease in distress owing to low desire) for 
      premenopausal and postmenopausal women. Mean FSFI total scores were numerically 
      higher at weeks 4, 12, and 20 than at baseline, irrespective of menopausal status 
      of the patients. CLINICAL IMPLICATIONS: The results of this study support the 
      safety and tolerability of flibanserin for the treatment of HSDD in premenopausal 
      and naturally postmenopausal women. STRENGTHS AND LIMITATIONS: Although this 
      open-label study was designed to be 28 weeks long, it was discontinued early by 
      the sponsor, and patients' maximum duration of exposure to flibanserin was 23.9 
      weeks. The open-label design and lack of a placebo-controlled arm are other study 
      limitations. CONCLUSION: In this open-label study, flibanserin 100 mg once daily 
      at bedtime was generally safe and well tolerated by premenopausal and naturally 
      postmenopausal women with HSDD. Simon JA, Derogatis L, Portman D, et al. 
      Flibanserin for Hypoactive Sexual Desire Disorder: An Open-Label Safety Study. J 
      Sex Med 2018;15:387-395.
CI  - Copyright (c) 2018. Published by Elsevier Inc.
FAU - Simon, James A
AU  - Simon JA
AD  - George Washington University and Women's Health & Research Consultants, 
      Washington, DC, USA. Electronic address: jsimon@JamesASimonMD.com.
FAU - Derogatis, Leonard
AU  - Derogatis L
AD  - Johns Hopkins University School of Medicine, Baltimore, MD, USA.
FAU - Portman, David
AU  - Portman D
AD  - Columbus Center for Women's Health Research, Columbus, OH, USA.
FAU - Brown, Louise
AU  - Brown L
AD  - Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ, USA.
FAU - Yuan, James
AU  - Yuan J
AD  - Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ, USA.
FAU - Kissling, Robert
AU  - Kissling R
AD  - Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01103362
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - Netherlands
TA  - J Sex Med
JT  - The journal of sexual medicine
JID - 101230693
RN  - 0 (Benzimidazoles)
RN  - 37JK4STR6Z (flibanserin)
SB  - IM
MH  - Adult
MH  - Benzimidazoles/*administration & dosage/adverse effects
MH  - Dizziness/chemically induced
MH  - Female
MH  - Humans
MH  - Libido
MH  - Middle Aged
MH  - Nausea/chemically induced
MH  - Premenopause
MH  - Sexual Behavior/*drug effects
MH  - Sexual Dysfunctions, Psychological/*drug therapy
OTO - NOTNLM
OT  - Flibanserin
OT  - Hypoactive Sexual Desire Disorder
OT  - Safety
EDAT- 2018/03/06 06:00
MHDA- 2019/10/01 06:00
CRDT- 2018/03/06 06:00
PHST- 2017/10/16 00:00 [received]
PHST- 2017/12/19 00:00 [revised]
PHST- 2017/12/29 00:00 [accepted]
PHST- 2018/03/06 06:00 [entrez]
PHST- 2018/03/06 06:00 [pubmed]
PHST- 2019/10/01 06:00 [medline]
AID - S1743-6095(18)30006-7 [pii]
AID - 10.1016/j.jsxm.2017.12.016 [doi]
PST - ppublish
SO  - J Sex Med. 2018 Mar;15(3):387-395. doi: 10.1016/j.jsxm.2017.12.016.