Effects of Ospemifene on Brain Activation Patterns in Women With Sexual Interest-arousal Disorders
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
Ospemifene is the first oral and non-hormonal treatment for moderate or severe vulvo-vaginal
atrophy (VVA) in postmenopausal women who are not candidates to treatment with local
oestrogens. Its effects are mediated though the regeneration of the proportion of superficial
and intermediate cells of the vagina, improving menopausal symptomatology such as dryness and
dyspareunia.
Only two studies to date have directly compared brain activation patterns in women with
normal sexual function with women complaining with hypoactive sexual desire disorder. Arnow
et al. demonstrated that women with normal sexual function showed brain activations in
multiple regions different from women with FSIAD. When comparing the two groups, women with
normal sexual function showed greater activation of the bilateral entorhinal cortex while
women with FSIAD exhibited greater activation of the medial frontal gyrus, right inferior
frontal gyrus, and bilateral putamen. The medial frontal gyrus activation has been associated
with self-monitoring; thus, it is possible that women with FSIAD allocate more attention to
monitoring their response, which may be inhibitory to sexual functioning. The other study was
done by Woodard and colleges showing that women with normal sexual function showed
significantly differences on cerebral activation in comparison with women with FSIAD.
These differences observed in women with FSIAD could suggest that they may have alterations
in activation of limbic and cortical structures responsible for acquiring, encoding, and
retrieving memory, the processing and memory of emotional reactions, and areas responsible
for heightened attention to one's own physical state.
For this reason the authors believe that it is essential to determine if the effect of
ospemifene on the improvement on sexual function is due to the improvement on the vagina
tract or due to its effect on brain function.