Gestrinone and Endothelial Function in Young Women | NCT06402344

Studies
Gestrinone and Endothelial Function in Young Women

NCT06402344

Sponsor

Hospital Israelita Albert Einstein

Status

Active, not recruiting

Last Update Posted

Jul 2, 2026Actual

Enrollment

90Estimated

Phase

Not provided

Conditions

Cardiovascular Diseases

Interventions

Hormonal implant
Control group

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 22, 2024Actual

Primary Completion Date

Dec 30, 2025Actual

Completion Date

Aug 5, 2026Estimated

First Submitted Date

Apr 26, 2024

First Submission Date that Met QC Criteria

May 2, 2024

First Posted Date

May 7, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2026

Last Update Posted Date

Jul 2, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to assess the association of hormonal implant with gestrinone in cardiovascular health outcomes in young women.

Detailed Description

After being informed about the study, volunteers will be screened in accordance with eligibility criteria. Eligible volunteers will be invited to appear to the research institute and participate in the study. All volunteers giving the written informed consent will perform all assessments in the same day at their visit.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gestrinone implant		Young women using hormonal implant with gestrinone.	Other: Hormonal implant
Control group		Young women who never used hormonal implant with gestrinone.	Other: Control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hormonal implant	Other	History of at least 1 hormonal implant with gestrinone in the last 6 months, applied by the participant's private doctor.	Gestrinone implant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Endothelial function	Brachial artery endothelial function assessed by flow-mediated dilation (FMD).	Day 1.

Secondary Outcomes

Measure	Description	Time Frame
Arterial stiffness	Carotid-femoral pulse wave velocity (PWV).	Day 1.
Heart rate	Heart rate assessed together with the cardiac autonomic modulation procedure.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women;
Between 25 and 45 years age;
History of ≥ 1 hormonal implant with gestrinone in the last 6 months or never had used any hormonal implants.

Exclusion Criteria:

Pregnancy;
Menopause;
Smoking;
Moderate-high consumption of alcoholic beverages (above 14 drinks per week);
Previous cardiovascular event (e.g. myocardial infarction and stroke);
Uncontrolled psychiatric disease;
Ventricular arrhythmia;
Using antibiotics or corticoids;
Regular contraceptive use (estrogen and progesterone);
Use of illicit drugs.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Young women.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luciana Diniz Nagem Janot de Matos, MD, PhD	Medical Referencee - Rehabilitation Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Israelita Albert Einstein		São Paulo	São Paulo	05652-900	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

There will be no individual participant data (IPD) shared.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D035061	Control Groups

Ancestor Terms

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design

Browse Leaves

Not provided

Browse Branches

Not provided