Lack of influence of dyspareunia on the beneficial effect of intravaginal prasterone (dehydroepiandrosterone, DHEA) on sexual dysfunction in postmenopausal women.
BACKGROUND
We have previously observed that intravaginal prasterone (dehydroepiandrosterone, DHEA) improved all domains of female sexual dysfunction (FSD).


OBJECTIVE
Investigate the influence of moderate/severe pain at sexual activity (dyspareunia) (MSD) at baseline on FSD following prasterone administration.


METHODS
The effect of daily administration of prasterone (0, 3.25 mg, 6.5 mg or 13 mg) for 12 weeks on FSD in 215 postmenopausal women with or without MSD at baseline was evaluated in a prospective, randomized, double-blind, and placebo-controlled phase III clinical trial.


METHODS
Differences were examined on desire, arousal and orgasm.


RESULTS
Comparable benefits were observed in women not having MSD (n = 56) vs. those having MSD (n = 159). The benefits over placebo in prasterone-treated women for desire, avoiding intimacy and vaginal dryness as well as for the total sexual domain of the MENQOL (Menopause Specific Quality of Life) questionnaire, ranged between 18.0% and 38.2% with P values of <0.05 or <0.01 except in one out of 12 subgroups. For the arousal/sensation, arousal/lubrication and summary score of the ASF (Abbreviated Sexual Function) questionnaire, in the MSD+ group, improvements of 64.2% (P = 0.01), 118% (P = 0.001) and 31.1% (P = 0.03) were observed over placebo, respectively, while similar differences (58.0%, 67.6% and 32.1%) did not reach statistical significance in the MSD- group having up to only 44 prasterone-treated women compared with 119 in the MSD+ group.


CONCLUSIONS
No MSD at baseline does not apparently affect the effects of intravaginal prasterone on sexual dysfunction. Knowing the absence of significant effects of estrogens on FSD, the present data suggest that vulvovaginal atrophy (VVA) and vulvovaginal sexual dysfunction (VVSD) are two different consequences of sex steroid deficiency at menopause which can respond independently. In addition, the present data seriously question the justification of pain being part of FSD as well as the separation of FSD into separate domains.
EndoCeutics Inc., Quebec City, QC, Canada.
Fernand
F
Labrie
David
D
Archer
Céline
C
Bouchard
Michel
M
Fortier
Leonello
L
Cusan
José-Luis
JL
Gomez
Ginette
G
Girard
Mira
M
Baron
Normand
N
Ayotte
Michèle
M
Moreau
Robert
R
Dubé
Isabelle
I
Côté
Claude
C
Labrie
Lyne
L
Lavoie
Lucy
L
Gilbert
Céline
C
Martel
John
J
Balser
D000282:Administration, Intravaginal; D000328:Adult; D000368:Aged; D000728:Androgens / Q000008:administration & dosage*; D001143:Arousal / Q000187:drug effects; D003687:Dehydroepiandrosterone / Q000008:administration & dosage*; D004311:Double-Blind Method; D004414:Dyspareunia / Q000150:complications*; D004967:Estrogens / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008593:Menopause; D008875:Middle Aged; D009412:Nerve Fibers / Q000187:drug effects; D009948:Orgasm / Q000187:drug effects; D017698:Postmenopause / Q000187:drug effects; D011446:Prospective Studies; D011788:Quality of Life; D012725:Sexual Behavior / Q000187:drug effects; D020018:Sexual Dysfunctions, Psychological / Q000188:drug therapy*; D013488:Suppositories; D011795:Surveys and Questionnaires; D014621:Vagina / Q000294:innervation; D014623:Vaginal Diseases / Q000188:drug therapy
D000728:Androgens; D004967:Estrogens; D013488:Suppositories; D003687:Dehydroepiandrosterone
Androgens; Dehydroepiandrosterone (DHEA); Female Sexual Dysfunction; Intracrinology; Low Arousal; Low Desire; Nerve fibers; Vagina