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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04677491
Other study ID # 2020-001514-38
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 1, 2021
Est. completion date December 1, 2022

Study information

Verified date February 2022
Source Hospital Clinic of Barcelona
Contact EDUARD MENSION COLL
Phone 626207171
Email edmension@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ospemifene 60 mg
Ospemifene vs placebo
Behavioral:
fMRI experiments
Participants will see sexually explicit video clips that alternate with non-sexual clips and neutral color projection and b) smell alternate pheromones with clear air and pine aroma.

Locations

Country Name City State
Spain Hospital Clínic de Barcelona Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary a Activation of each brain circuits Is measured by the blood-oxygen level dependent (BOLD) 3 months
Secondary Vaginal pH vaginal pH measured by ph roll from 1 to 14 3 months
Secondary Vaginal maturation index vaginal maturation index meadured by vaginal citology on percentage from 0 to 100 divided in superficial, intermediate and basal cells 3 months
Secondary Vaginal health index To describe if there is a correlation between changes in the visual examination of the vagina. using the vaginal health index: from 5 to 25 (min-max). 3 months
Secondary Female Sexual Function Index Questionaire from 18 to 90 (min-max). 3 months
Secondary DSM V evaluation DSM Criteria 3 months
Secondary Quality of Life Scale Questionaire PHQ9 (Patient health questionaire 9) from 0 to 27 (min-max) 3 months
Secondary Female Sexual Distress Scale Questionaire FSFI (Female Sexual Function Index) from 18 to 90 (min-max). 3 months
Secondary Social Functioning Questionnaire Questionaire SF12 (Physical and Mental Health Composite Scores) from 0 to 12 (min-max) 3 months
Secondary Patient Health Questionnaire-9 Questionaire from 0 to 9 3 months
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