Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432816
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-22
Brief Title:
Efficacy of Nano-Pso Therapy in Menopause
Sponsor:
Distribuidora Biolife SA de CV
Organization:
Distribuidora Biolife SA de CV
Study Overview
Official Title:
Efficacy of Nano-Pso Therapy Compared to Placebo in the Control of Vasomotor Symptomatology in Early Menopause
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
The menopausal transition in women marks the end of female reproductive capacity and is associated with an estrogenic hormonal imbalance that begins to be noticeable around the fifth decade of life This process also known as climacteric involves the transition from an active to an inactive reproductive stage and can last for several years before menopause which is defined as the last menstruation
During the climacteric the reduction of estrogen triggers clinical signs and symptoms that affect various systems of the body such as the central nervous system the cardio-metabolic system the musculoskeletal system and sexual function Vasomotor symptoms such as hot flashes are common manifestations at this stage and affect approximately 75-80 of women in the transition to menopause with an intensity ranging from moderate to severe in most cases These symptoms can have a negative impact on quality of life affecting sleep functional capacity and work attendance
Menopausal hormone therapy MHT with estrogens and progesterone is the first line of treatment for vasomotor symptoms in menopause However some women cannot or prefer not to use MHT due to its adverse effects which has led to the development of second-line therapies such as selective serotonin reuptake inhibitors gabapentinoids clonidine and oxybutynin These non-hormonal therapies may also have minor side effects that may lead to discontinuation of treatment
In the search for therapeutic alternatives with fewer adverse effects compounds such as punic acid omega 5 and its metabolites such as conjugated linoleic acid have been investigated Nanoemulsified pomegranate seed oil omega 5 has been shown to be a compound with high antioxidant capacity and neuroprotective effects making it a promising option for the management of symptoms associated with menopause especially those related to alterations at the level of the menopause central Preliminary studies have shown encouraging results in animal models and initial clinical trials suggesting the need for additional research in specific populations such as menopausal women
GENERAL OBJECTIVE
Compare 6-month NANO-PSO therapy versus placebo in the control of vasomotor symptoms in early menopause assessed via the Menopause Rating Scale
SPECIFIC OBJECTIVES
Describe the sociodemographic and clinical characteristics of the Study population
Analyze vasomotor symptoms in menopausal patients at baseline with the MRS scale
Compare vasomotor symptoms with the use of NANO-PSO vs Placebo
Compare the percentage of treatment response regarding vasomotor symptoms with the use of nano pso vs placebo at 3 and 6 months
Population study Patients who come first class outpatient climacteric consultation that presents with early menopause and MRS scale 15 points without treatment
With a sample convenience the aim is to recruit 45 patients per group with a total of 90 patients Intervention by compounds - Leading to treatment of NANO-PSO or Oil of pomegranate seed with nanotechnology they are capsules with a net content of 640 mg with a dosage indicated by sponsor of 2 capsules in fast
- Placebo physically identical to NANO-PSO capsules Soft gelatin capsules 640 mg edible oil 35for PLACEBO being the following information Oil edible oval shape 640 mg
During the climacteric the reduction of estrogen triggers clinical signs and symptoms that affect various systems of the body such as the central nervous system the cardio-metabolic system the musculoskeletal system and sexual function Vasomotor symptoms such as hot flashes are common manifestations at this stage and affect approximately 75-80 of women in the transition to menopause with an intensity ranging from moderate to severe in most cases These symptoms can have a negative impact on quality of life affecting sleep functional capacity and work attendance
Menopausal hormone therapy MHT with estrogens and progesterone is the first line of treatment for vasomotor symptoms in menopause However some women cannot or prefer not to use MHT due to its adverse effects which has led to the development of second-line therapies such as selective serotonin reuptake inhibitors gabapentinoids clonidine and oxybutynin These non-hormonal therapies may also have minor side effects that may lead to discontinuation of treatment
In the search for therapeutic alternatives with fewer adverse effects compounds such as punic acid omega 5 and its metabolites such as conjugated linoleic acid have been investigated Nanoemulsified pomegranate seed oil omega 5 has been shown to be a compound with high antioxidant capacity and neuroprotective effects making it a promising option for the management of symptoms associated with menopause especially those related to alterations at the level of the menopause central Preliminary studies have shown encouraging results in animal models and initial clinical trials suggesting the need for additional research in specific populations such as menopausal women
GENERAL OBJECTIVE
Compare 6-month NANO-PSO therapy versus placebo in the control of vasomotor symptoms in early menopause assessed via the Menopause Rating Scale
SPECIFIC OBJECTIVES
Describe the sociodemographic and clinical characteristics of the Study population
Analyze vasomotor symptoms in menopausal patients at baseline with the MRS scale
Compare vasomotor symptoms with the use of NANO-PSO vs Placebo
Compare the percentage of treatment response regarding vasomotor symptoms with the use of nano pso vs placebo at 3 and 6 months
Population study Patients who come first class outpatient climacteric consultation that presents with early menopause and MRS scale 15 points without treatment
With a sample convenience the aim is to recruit 45 patients per group with a total of 90 patients Intervention by compounds - Leading to treatment of NANO-PSO or Oil of pomegranate seed with nanotechnology they are capsules with a net content of 640 mg with a dosage indicated by sponsor of 2 capsules in fast
- Placebo physically identical to NANO-PSO capsules Soft gelatin capsules 640 mg edible oil 35for PLACEBO being the following information Oil edible oval shape 640 mg
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None