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

What this trial studies

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.

Conditions in scope

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

Interventions

• Ospemifene 60 mg (Drug) — Ospemifene vs placebo
• 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.

Who can join

Women only · Adults (Child, Adult, Older Adult)

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.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE4
• Start date: 2021-11-01
• Primary completion: 2022-11-01
• Last update posted: 2025-09-15
• First posted: 2020-12-21

Sponsor & contact

Lead sponsor: Hospital Clinic of Barcelona (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• a Activation of each brain circuits (3 months)
  Is measured by the blood-oxygen level dependent (BOLD)

Related ClearedRx care

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