Effects of Ospemifene on Brain Activation Patterns in Women With Sexual Interest-arousal Disorders

NCT04677491 | Completed Phase 4

• 1 other identifier: 2020-001514-38
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vulvovaginal Signs and Symptoms; Genitourinary Syndrome of Menopause; Sexual; Disorder, Arousal, Female

Keywords

Sexual Disorder; Genitourinary Syndrome of Menopause

Outcome Measures

Primary Outcomes (1)

• a Activation of each brain circuits

  Is measured by the blood-oxygen level dependent (BOLD)

  3 months

Secondary Outcomes (9)

• Vaginal pH

  3 months

• Vaginal maturation index

  3 months

• Vaginal health index

  3 months

• Female Sexual Function Index

  3 months

• DSM V evaluation

  3 months

Study Arms (2)

VVA-FSIAD ospemifene group

ACTIVE COMPARATOR

Women treated with ospemifene 60 mg/day

Drug: Ospemifene 60 mg; Behavioral: fMRI experiments

VVA-FSIAD placebo group

PLACEBO COMPARATOR

Women treated with placebo

Behavioral: fMRI experiments

Interventions

Ospemifene 60 mg DRUG

Ospemifene vs placebo

Also known as: Senshio

VVA-FSIAD ospemifene group

fMRI experiments BEHAVIORAL

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.

VVA-FSIAD ospemifene group; VVA-FSIAD placebo group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Informed written consent of the patient.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Coitus; Sexual Dysfunction, Physiological

Interventions

Ospemifene

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior; Genital Diseases; Urogenital Diseases

Study Officials

• Camil Castelo-Branco

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Model Details: Pilot study, randomised prospective study, triple blind, placebo controlled.

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 21, 2020
• Study Start: November 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2023
• Last Updated: September 15, 2025

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)