PMID- 31735618
OWN - NLM
STAT- MEDLINE
DCOM- 20201019
LR  - 20201019
IS  - 1743-6109 (Electronic)
IS  - 1743-6095 (Linking)
VI  - 17
IP  - 1
DP  - 2020 Jan
TI  - Effects of Alcohol Administered With Flibanserin in Healthy Premenopausal Women: 
      A Randomized, Double-Blind, Single-Dose Crossover Study.
PG  - 83-93
LID - S1743-6095(19)31459-6 [pii]
LID - 10.1016/j.jsxm.2019.10.004 [doi]
AB  - INTRODUCTION: Flibanserin is approved in the United States and Canada for the 
      treatment of hypoactive sexual desire disorder in premenopausal women. AIM: The 
      purpose of this trial was to evaluate the safety of concomitant administration of 
      flibanserin with alcohol. METHODS: In this single-center, randomized, 
      double-blind, single-dose, crossover study, participants were randomly assigned 
      to 1 of 12 sequences to receive each of 7 treatments: flibanserin 100 mg or 
      placebo with ethanol 0.2 g/kg, 0.4 g/kg, or 0.6 g/kg, or flibanserin 100 mg only. 
      Treatments were administered using a worst-case approach that included morning 
      dosing and consumption of alcohol within 10 minutes. MAIN OUTCOME MEASURE: The 
      primary end point was the proportion of participants who experienced dizziness, 
      syncope, or hypotension. Safety end points included orthostatic vital signs. 
      RESULTS: The study included 96 premenopausal women (mean age 31 +/- 8 years). The 
      incidence of dizziness for ethanol + flibanserin was 39.8% for ethanol 0.6 g/kg, 
      34.1% for 0.4 g/kg, and 27.4% for 0.2 g/kg compared with 31.1% for flibanserin 
      without ethanol. Based on the available vital signs data, there was no effect of 
      ethanol concentration on orthostatic blood pressure, vertigo, or hypotension; no 
      instances of syncope were observed. The overall incidence of adverse events (AEs) 
      was similar when flibanserin was administered alone (96.7%) or with ethanol 
      (90.5-97.6%). CLINICAL IMPLICATIONS: Consumption of the tested amounts of alcohol 
      (0.2-0.6 g/kg) does not have an additive effect on the AE profile of flibanserin 
      100 mg in healthy premenopausal women. STRENGTHS & LIMITATIONS: Strengths include 
      the study population (premenopausal women, as indicated for flibanserin) and 
      range of ethanol doses. Limitations include the morning dosing of study 
      medication, which is inconsistent with the bedtime dosing recommended for 
      flibanserin, and the method of handling missing vital sign measurements. 
      CONCLUSION: Co-administration of flibanserin 100 mg with varying doses of ethanol 
      resulted in few AEs of special interest, with no notable alcohol dose response. 
      However, a significantly greater percentage of participants administered 
      flibanserin with 0.6 g/kg and 0.4 g/kg of alcohol were characterized as 
      "Participants in Whom Standing Blood Pressure Was Not Obtained" compared with 
      participants administered flibanserin alone. Simon JA, Clayton AH, Parish SJ, 
      et al. Effects of Alcohol Administered With Flibanserin in Healthy Premenopausal 
      Women: A Randomized, Double-Blind, Single-Dose Crossover Study. J Sex Med 
      2020;17:83-93.
CI  - Copyright (c) 2019. Published by Elsevier Inc.
FAU - Simon, James A
AU  - Simon JA
AD  - George Washington University, Washington, DC, USA. Electronic address: 
      jsimon@jamesasimonmd.com.
FAU - Clayton, Anita H
AU  - Clayton AH
AD  - University of Virginia School of Medicine, Charlottesville, Virginia, USA.
FAU - Parish, Sharon J
AU  - Parish SJ
AD  - Weill Cornell Medical College, New York, New York, USA.
FAU - Apfel, Stuart C
AU  - Apfel SC
AD  - Albert Einstein College of Medicine, Yeshiva University, New York, New York, USA.
FAU - Millheiser, Leah
AU  - Millheiser L
AD  - Stanford University School of Medicine, Stanford, California, USA.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20191115
PL  - Netherlands
TA  - J Sex Med
JT  - The journal of sexual medicine
JID - 101230693
RN  - 0 (Benzimidazoles)
RN  - 37JK4STR6Z (flibanserin)
RN  - 3K9958V90M (Ethanol)
SB  - IM
MH  - Adult
MH  - Benzimidazoles/*administration & dosage
MH  - Cross-Over Studies
MH  - Dizziness/epidemiology
MH  - Double-Blind Method
MH  - Drug Interactions
MH  - Ethanol/*administration & dosage
MH  - Female
MH  - Humans
MH  - Premenopause
MH  - Sexual Dysfunctions, Psychological/drug therapy
MH  - Young Adult
OTO - NOTNLM
OT  - Dizziness
OT  - Ethanol
OT  - Flibanserin
OT  - Hypoactive Sexual Desire Disorder
OT  - Hypotension
EDAT- 2019/11/19 06:00
MHDA- 2020/10/21 06:00
CRDT- 2019/11/19 06:00
PHST- 2019/05/07 00:00 [received]
PHST- 2019/10/01 00:00 [revised]
PHST- 2019/10/02 00:00 [accepted]
PHST- 2019/11/19 06:00 [pubmed]
PHST- 2020/10/21 06:00 [medline]
PHST- 2019/11/19 06:00 [entrez]
AID - S1743-6095(19)31459-6 [pii]
AID - 10.1016/j.jsxm.2019.10.004 [doi]
PST - ppublish
SO  - J Sex Med. 2020 Jan;17(1):83-93. doi: 10.1016/j.jsxm.2019.10.004. Epub 2019 Nov 
      15.