Effects of Ospemifene on Brain Activation Patterns in Women With Sexual Interest-arousal Disorders (NCT04677491) | Clinical Trial Compass
CompletedPhase 4
Effects of Ospemifene on Brain Activation Patterns in Women With Sexual Interest-arousal Disorders
Spain25 participantsStarted 2021-11-01
Plain-language 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.
Who can participate
Sex
FEMALE
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Inclusion criteria:
* Women 40 year old or older who have been diagnosed with menopause (either chemical, surgical or natural menopause)
* No menstruation for at least a year.
* Moderate or severe VVA diagnosis (defined by the presence of ≤ 5% of superficial cells and vaginal pH \> 5).
* For homogenisation of brain patterns, women had to be right-handed.
* Women should be strictly heterosexual, in a stable relationship of at least 1 year duration (with expectations of remaining with the same relationship), and have had experience viewing sexually explicit images
* For the FSIAD groups, women will be included if they are diagnosed with FSIAD, defined according to the criteria of DSM-V and confirmed by a structured clinical interview and by means of the scores of the SFQ and the FSDS-R (with a score of ≤20 for FSFI and ≥15 for the FSDS-R, respectively). These criteria will be an exclusion criterion for women without FSIAD.
* Informed written consent of the patient.
Exclusion criteria
* Women with known history of mental illness, history of drug or alcohol abuse.
* Women with VVA treatment (oestrogens or ospemifene) at any time during the last 6 months, and/or laser treatment at any time during the last year.
* Use of medication or herbal preparations at any time during the last 3 months for the purpose of improving sexual performance.
* Women who have received any medication previous to the study inclusion, that may alter or interfere with brain activation patterns (psychoac…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
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1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.