Prevenox in menopausal women

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Clinical evaluation of Prevenox in menopausal women

Secondary indentifying numbers:

Prev/MCli-01

Issuing authority of the secondary identifying numbers:

National Centre for Scientific Research (CNIC)

Source(s) of monetary or material support:

National Centre for Scientific Research (CNIC)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Daysi

Midle name:

Antonia

Last name:

Navarro Despaigne

Medical Specialty :

Second Degree Specialist in Endocrinology

Affiliation:

National Institute of Endocrinology

Postal address:

Calle Zapata y D, Vedado. Plaza de la Revolucion

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-58051162

Email address:

daysi.navarro@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

07/09/2026

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Menopausal women

Health condition(s) code:

Climacteric

Intervention(s):

Group 1 Prevenox (Experimental): 2 tablets of Prevenox of 5 mg daily by oral route, one taken with lunch and the other with dinner during 6 months. Group 2 Placebo (Control): 2 placebo tablets daily by oral route, one taken with lunch and the other with dinner during 6 months.

Intervention code:

Antioxidants

Dietary Supplements

Placebo

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

LDL-C (Value measured in mmol/L).Measurement time: At baseline, 3 months and 6 months of treatment

Key secondary outcomes:

1. Total Cholesterol (Value measured in mmol/L).Measurement time: At baseline, 3 months and 6 months of treatment 2. HDL-C (Value measured in mmol/L).Measurement time: At baseline, 3 months and 6 months of treatment

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Female

Minimum age:

35 years

Maximum age:

None

Inclusion criteria:

The sample will consist of women ≥ 35 years old, who agree to participate in the study by signing their informed consent.

Exclusion criteria:

1. Age under 35 years 2. Menopause 3. Diagnosed neoplasms 4. Decompensated chronic non-communicable diseases 5. Surgery within the last 3 months 6. Psychiatric disorders 7. Renal and/or hepatic insufficiency 8. Any other special condition that, in the physician's judgment, puts their health and life at risk during the study

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

N/A

Target sample size:

100

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Daysi

Middle Name:

Antonia

Last Name:

Navarro Despaigne

Specialty:

Second Degree Specialist in Endocrinology

Affiliation:

National Institute of Endocrinology

Postal Address:

Calle Zapata y D, Vedado. Plaza de la Revolucion

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-58051162

Email :

daysi.navarro@infomed.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Julio

Middle Name:

Cesar

Last Name:

Fernandez Travieso

Specialty:

Pharmaceutical Science Degree

Affiliation:

National Centre for Scientific Research (CNIC)

Postal Address:

Avenida 15 y 158, Cubanacan, Playa

City:

Havana

Country:

Cuba

Zip Code:

10600

Telephone:

+53-59958136

Email :

julio.fernandez@cnic.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

National Institute of Endocrinology

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

05/02/2026

Postal address of Ethic Committee :

Calle Zapata y D, Vedado, Plaza de la Revolucion, ZC: 10400, Havana. Cuba

Telephone:

+53-78327275

Email:

yanetra@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

07/06/2027

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000481

Date of Registration in Primary Registry:

20/07/2026

Record Verification Date:

2026/08/06

Next update date:

2027/08/06

Link to the spanish version:

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Prevenox in menopausal women

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