Genitourinary Syndrome of Menopause Clinical Trial
— EROSOfficial title:
Effects of Ospemifene on Brain Activation Patterns in Women With Sexual Interest-arousal Disorders
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.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | December 1, 2022 |
Est. primary completion date | November 1, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | 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 (psychoactive drugs). - Women with history of sexual offenses. - Women with abnormal vision that would impair the visualisation of the images and the olfactory stimuli. - Women with claustrophobia or implants that would preclude fMRI procedures. - Women with diagnosis of depression assessed by PHQ self-administered questionnaire. - Patients who had undergone vaginal surgery in the last 12 months. - Women who did not sign the written informed consent. - Hypersensitivity to the active substance or to any of the excipients included in Senshio. - Past or active history of venous thromboembolic events (VTE), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis. - Unexplained vaginal bleeding. - Patients with suspected breast cancer or who are receiving active treatment (including adjuvant treatment) for breast cancer. - Suspicion of neoplasia or active neoplasia dependent on sex hormones (eg endometrial cancer). - Patients with signs or symptoms of endometrial hyperplasia; In this group of patients, safety has not been studied. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clínic de Barcelona | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Clinic of Barcelona |
Spain,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05812924 -
A Novel Therapy for Breast Cancer Survivors With Genitourinary Syndrome of Menopause
|
Phase 2 | |
Completed |
NCT04535323 -
Platelet Rich Plasma for the Treatment of Genitourinary Syndrome of Menopause in Patients With Stage 0-III Breast Cancer
|
Phase 1 | |
Completed |
NCT03331328 -
MonaLisa Touch Randomized Double-Blind Placebo Controlled Study
|
N/A | |
Recruiting |
NCT04746456 -
Vulvovaginal Atrophy Questionnaire (VVAQ): Psychometric Validation of a Novel PROM
|
||
Withdrawn |
NCT04606550 -
MonaLisa Laser Intervention for Post-Menopausal Breast Cancer Patients: A SHE CAN Study
|
N/A | |
Completed |
NCT04705883 -
Vaginal Prasterone In Vaginal Atrophy In Breast Cancer Survivors
|
Phase 4 | |
Recruiting |
NCT05953090 -
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
|
N/A | |
Active, not recruiting |
NCT04619485 -
Sexual and Vaginal Health in Breast Cancer Women Receiving Aromatase Inhibitors Before and After CO2 Laser Therapy
|
N/A | |
Completed |
NCT04607798 -
Multi-polar RF and PEMF for Treatment of Vulvovaginal Atrophy
|
N/A | |
Recruiting |
NCT06124820 -
RCT Comparing Intravaginal Laser Therapy to Sham in Post-menopausal Women With Recurrent Urinary Tract Infections
|
N/A | |
Completed |
NCT05561972 -
The Ultrasonographic Assessment of Efficacy of Injectable Hyaluronic Acid for Genitourinary Syndrome of Menopause
|
N/A | |
Recruiting |
NCT05571527 -
Comparison of Vaginal Hyaluronic Acid Treatment Over Autologous Platelet Rich Plasma Treatment for Genitourinary Syndrome of Menopause
|
N/A | |
Not yet recruiting |
NCT06425978 -
Efficacy of the Use of Cellular Matrix/ A-CP-HA Kit
|
Phase 4 | |
Recruiting |
NCT05672901 -
Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause
|
N/A | |
Recruiting |
NCT03782480 -
Examining Effects of Intrarosa in Women With Genitourinary Syndrome of Menopause/Vulvovaginal Atrophy
|
Phase 3 | |
Recruiting |
NCT06028009 -
PRP Injections for Genitourinary Syndrome of Menopause
|
N/A | |
Not yet recruiting |
NCT06007027 -
Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors
|
N/A | |
Terminated |
NCT03857893 -
New Non-Hormonal Treatment by Radiofrequency for Vulvo-Vaginal Atrophy
|
N/A | |
Completed |
NCT05782920 -
Management of Cancer Therapy Related Vulvovaginal Atrophy
|
N/A | |
Completed |
NCT05464654 -
Vaginal Biorevitalization With Polydeoxyribonucleotides for the Improvement of the Genitourinary Syndrome of Menopause
|
N/A |