Status:
COMPLETED
Effects of Ospemifene on Brain Activation Patterns in Women With Sexual Interest-arousal Disorders
Lead Sponsor:
Hospital Clinic of Barcelona
Conditions:
Vulvovaginal Signs and Symptoms
Genitourinary Syndrome of Menopause
Eligibility:
FEMALE
Phase:
PHASE4
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 effect...
Detailed Description
To evaluate changes from baseline in brain activation patterns, by using functional magnetic resonance imaging (fMRI) techniques and sexual stimuli, in postmenopausal women with moderate to severe vul...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04677491
Start Date
November 1 2021
End Date
December 1 2023
Last Update
September 15 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Clínic de Barcelona
Barcelona, Barcelona, Spain, 08036