Specific Supplementation in Counteracting the Adverse Effects of Oral Contraceptives

NCT ID: NCT07071389

Last Updated: 2025-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-08

Study Completion Date

2018-12-21

Brief Summary

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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.

Detailed Description

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Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Control group: oral contraceptive Study group: oral contraceptive + specific supplement
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control group

Patients prescribed estroprogestinic oral contraceptive

Group Type ACTIVE_COMPARATOR

Oral contraceptive

Intervention Type DRUG

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

Study group

Patients prescribed estroprogestinic oral contraceptive were treatedwith Zyxelle supplement

Group Type EXPERIMENTAL

Zyxelle

Intervention Type DIETARY_SUPPLEMENT

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

Oral contraceptive

Intervention Type DRUG

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

Interventions

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Zyxelle

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

Intervention Type DIETARY_SUPPLEMENT

Oral contraceptive

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Body Mass Index: 18-30 Kg/m2;
2. Prescription for COC treatment

Exclusion Criteria

1. diabetes;
2. previous or existing breast pathologies;
3. hypertension;
4. obesity;
5. smoking habits;
6. cardiovascular disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Lo.Li.Pharma s.r.l

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Studio Medico Anteo

Terni, TR, Italy

Site Status

Countries

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Italy

Other Identifiers

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000152

Identifier Type: -

Identifier Source: org_study_id

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