NCT06432816 Efficacy of Nano-Pso Therapy in Menopause
| NCT ID | NCT06432816 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Distribuidora Biolife SA de CV |
| Condition | Menopause |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-02-28 |
| Primary Completion | 2025-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2024-02-28 with a primary completion date of 2025-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Vasomotor syndrome is prevalent in 85% of postmenopausal women, hormone therapy in menopause is first-line therapy, but 38% of patients have some contraindication for its use. The medications indicated in this population presents adverse reactions, such as dryness of the mucous membranes, and insomnia in patients, and triggers to abandoned treatment due to poor response to the drug. Aligned with the safety of patients, we wish to test pomegranate seed oil with nanotechnology (NANOPSO), which has been reported to have positive results at a central level, due to its antioxidant effect, which could impact women in climacteric in a positive way. The study involves the participation of 90 patients divided into two groups, where placebo or Nano-PSO will be administered for 60 days, with a total follow-up of 120 days. It is established that patients must not have received previous treatments for menopausal symptoms. Therefore, it is expected that therapy with NANO-PSO compared to placebo will be more effective in controlling vasomotor symptoms in early menopause after 6 months of treatment evaluated by the MRS scale.
Eligibility Criteria
Inclusion Criteria: * In perimenopause with vasomotor syndrome and score greater than 15 points staged with the MRS scale * They agree to participate and sign the consent informed. * Without prior treatment to relieve the symptoms of menopause. Exclusion Criteria: * \- With pharmacological and/or hormonal therapy prescribed for menopause symptoms. * With psychiatric pathologies such as anxiety and depression. * Hysterectomized patients or patients with induced menopause surgically early. * Smoking * Malnutrition or low weight determined by a BMI ≤ 18.5Kg/m2 Elimination criteria. * Who do not attend follow-up to provide their treatment the 1, 2, 3 and 4 months for application of the MRS scale * That they leave the study voluntarily. * Who present any serious adverse effect to the drug.
Contact & Investigator
ARACELI ESPINOSA GUERREO
PRINCIPAL INVESTIGATOR
Maternal and child institute of the State of Mexico
Frequently Asked Questions
Who can join the NCT06432816 clinical trial?
This trial is open to female participants only, aged 45 Years or older, up to 55 Years, studying Menopause. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06432816 currently recruiting?
Yes, NCT06432816 is actively recruiting participants. Contact the research team at araceliespinosa68@yahoo.com for enrollment information.
Where is the NCT06432816 trial being conducted?
This trial is being conducted at Toluca, Mexico.
Who is sponsoring the NCT06432816 clinical trial?
NCT06432816 is sponsored by Distribuidora Biolife SA de CV. The principal investigator is ARACELI ESPINOSA GUERREO at Maternal and child institute of the State of Mexico. The trial plans to enroll 90 participants.