Efficacy of Nano-Pso Therapy in Menopause

Menopause Clinical Trial

Official title:

Efficacy of Nano-Pso Therapy Compared to Placebo in the Control of Vasomotor Symptomatology in Early Menopause

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06432816
• Other study ID #: IMI-09-23
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2024
• Est. completion date: July 2026

Study information

• Verified date: May 2024
• Source: Distribuidora Biolife SA de CV
• Contact: ARACELI ESPINOSA GUERREO, DRA.
• Phone: 527228228390
• Email: araceliespinosa68[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 2026
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Menopause

Intervention

Dietary Supplement:
• NANO-PSO
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

Other:
• PLACEBO
Placebo physically identical to NANO-PSO capsules: Soft gelatin capsules 640 mg edible oil 35for PLACEBO Oil edible, oval shape, 640 mg.

Locations

Country	Name	City	State
Mexico	Maternal and Child Institute of the State of Mexico	Toluca	State OF Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Distribuidora Biolife SA de CV

Country where clinical trial is conducted

Mexico, 

References & Publications (11)

Adel-Mehraban MS, Tansaz M, Mohammadi M, Yavari M. Effects of pomegranate supplement on menopausal symptoms and quality of life in menopausal women: A double-blind randomized placebo-controlled trial. Complement Ther Clin Pract. 2022 Feb;46:101544. doi: 10.1016/j.ctcp.2022.101544. Epub 2022 Feb 2. — View Citation

Auerbach L, Rakus J, Bauer C, Gerner C, Ullmann R, Wimmer H, Huber J. Pomegranate seed oil in women with menopausal symptoms: a prospective randomized, placebo-controlled, double-blinded trial. Menopause. 2012 Apr;19(4):426-32. doi: 10.1097/gme.0b013e3182345b2f. — View Citation

Avis NE, Crawford SL, Green R. Vasomotor Symptoms Across the Menopause Transition: Differences Among Women. Obstet Gynecol Clin North Am. 2018 Dec;45(4):629-640. doi: 10.1016/j.ogc.2018.07.005. Epub 2018 Oct 25. — View Citation

El Khoudary SR, McClure CK, VoPham T, Karvonen-Gutierrez CA, Sternfeld B, Cauley JA, Khalil N, Sutton-Tyrrell K. Longitudinal assessment of the menopausal transition, endogenous sex hormones, and perception of physical functioning: the Study of Women's Health Across the Nation. J Gerontol A Biol Sci Med Sci. 2014 Aug;69(8):1011-7. doi: 10.1093/gerona/glt285. Epub 2014 Jan 24. — View Citation

Kim JH, Kim YJ, Park Y. Conjugated Linoleic Acid and Postmenopausal Women's Health. J Food Sci. 2015 Jun;80(6):R1137-43. doi: 10.1111/1750-3841.12905. Epub 2015 May 11. — View Citation

Kim MJ, Yim G, Park HY. Vasomotor and physical menopausal symptoms are associated with sleep quality. PLoS One. 2018 Feb 20;13(2):e0192934. doi: 10.1371/journal.pone.0192934. eCollection 2018. — View Citation

Monteleone P, Mascagni G, Giannini A, Genazzani AR, Simoncini T. Symptoms of menopause - global prevalence, physiology and implications. Nat Rev Endocrinol. 2018 Apr;14(4):199-215. doi: 10.1038/nrendo.2017.180. Epub 2018 Feb 2. — View Citation

Mori-Okamoto J, Otawara-Hamamoto Y, Yamato H, Yoshimura H. Pomegranate extract improves a depressive state and bone properties in menopausal syndrome model ovariectomized mice. J Ethnopharmacol. 2004 May;92(1):93-101. doi: 10.1016/j.jep.2004.02.006. — View Citation

Petrou P, Ginzberg A, Binyamin O, Karussis D. Beneficial effects of a nano formulation of pomegranate seed oil, GranaGard, on the cognitive function of multiple sclerosis patients. Mult Scler Relat Disord. 2021 Sep;54:103103. doi: 10.1016/j.msard.2021.103103. Epub 2021 Jun 27. — View Citation

Posadzki P, Lee MS, Moon TW, Choi TY, Park TY, Ernst E. Prevalence of complementary and alternative medicine (CAM) use by menopausal women: a systematic review of surveys. Maturitas. 2013 May;75(1):34-43. doi: 10.1016/j.maturitas.2013.02.005. Epub 2013 Mar 14. — View Citation

Valdes-Sustaita B, Estrada-Camarena E, Gonzalez-Trujano ME, Lopez-Rubalcava C. Estrogen receptors-beta and serotonin mediate the antidepressant-like effect of an aqueous extract of pomegranate in ovariectomized rats. Neurochem Int. 2021 Jan;142:104904. doi: 10.1016/j.neuint.2020.104904. Epub 2020 Nov 18. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MENOPAUSE RATING SCALE	THE MRS IS A SCALE TO IDENTIFY THE FREQUENCY AND INTENSITY OF MENOPAUSE SYMPTOMS	1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.
Primary	FSH HORMONE	Follicle-stimulating hormone (FSH) is a pituitary hormone that regulates the reproductive cycle, helps control the menstrual cycle and the production of eggs in the ovaries.	1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.
Primary	PITTSBURG SCALE	The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire commonly used to evaluate sleep quality in adults. Created by the Department of Psychiatry at the University of Pittsburgh in 1988, the PSQI addresses both qualitative and quantitative aspects of sleep experienced during the month prior to its administration.	1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.
Primary	STRAW+10	The STRAW+10 system is a clinical and objective way to stage patients transitioning to menopause.	1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.
Secondary	PHQ-9	The PHQ-9 is a nine-item self-report measure that assesses the presence of depressive symptoms based on DSM-IV criteria.	1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.
Secondary	ESTRADIOL	Estradiol is a female sex hormone that regulates many processes in the body in the reproductive age, its evaluation will only be a control.	EVALUATION WILL BE CARRIED OUT AFTER SIX MONTHS.