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Could a menopause drug change how the brain responds to sex?

NCT ID NCT04677491

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked at whether ospemifene, a non-hormonal drug for vaginal dryness, also affects brain activity in postmenopausal women with sexual interest-arousal disorder. Twenty-five women took the drug or a placebo and underwent brain scans while watching sexual videos or smelling pheromones. The goal was to see if the drug's benefits come from changes in the brain, not just the vagina.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ospemifene 60 mg (Senshio)
What this could lead to
If successful, this study could clarify whether ospemifene improves sexual function by acting on the brain, not just the vagina, potentially guiding better treatments.
What could go wrong
This is a small, early-phase study with only 25 participants, so results may not apply widely. It focuses on brain scans, not direct symptom relief, and may not lead to new treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

25 people

The number who actually took part.

Started

Nov 2021

Finished

Dec 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hospital Clínic de Barcelona

    Barcelona, Barcelona, 08036, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.