NCT07071389

Brief Summary

Prospective, controlled study. Administration of a specifically formulated supplement to women prescribed oral contraceptives. Evaluation of: a) reduction of adverse effects of the treatment; b) improvement of patients' quality of life.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2019

Completed
6.3 years until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
Last Updated

July 17, 2025

Status Verified

April 1, 2019

Enrollment Period

12 months

First QC Date

April 3, 2019

Last Update Submit

July 8, 2025

Conditions

Contraception

Outcome Measures

Primary Outcomes (2)

  • cellulite

    patients' self-assessed evaluation through a questionnaire

    Change from baseline cellulite status at 3 months

  • water retention

    Bioelectrical impedance analysis (BIA)

    Change from baseline extracellular body water content at 3 months

Secondary Outcomes (1)

  • mood

    Change from baseline mood at 3 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

Patients prescribed estroprogestinic oral contraceptive

Drug: Oral contraceptive

Study group

EXPERIMENTAL

Patients prescribed estroprogestinic oral contraceptive were treatedwith Zyxelle supplement

Dietary Supplement: ZyxelleDrug: Oral contraceptive

Interventions

ZyxelleDIETARY_SUPPLEMENT

Patients in the study group receive Zyxelle dietary supplement along with the oral contraceptive

Study group
Oral contraceptiveDRUG

Patients in the study group receive daily dose of estroprogestinic oral contraceptive

Control groupStudy group

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body Mass Index: 18-30 Kg/m2;
  • Prescription for COC treatment

You may not qualify if:

  • diabetes;
  • previous or existing breast pathologies;
  • hypertension;
  • obesity;
  • smoking habits;
  • cardiovascular disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Studio Medico Anteo

Terni, TR, 05100, Italy

Location

MeSH Terms

Interventions

Contraceptives, Oral

Intervention Hierarchy (Ancestors)

Contraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic Uses
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Control group: oral contraceptive Study group: oral contraceptive + specific supplement
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2019

First Posted

July 17, 2025

Study Start

January 8, 2018

Primary Completion

December 21, 2018

Study Completion

December 21, 2018

Last Updated

July 17, 2025

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)