Specific Supplementation in Counteracting the Adverse Effects of Oral Contraceptives

Lo.Li.Pharma s.r.l

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Conditions

Contraception

Interventions

ZyxelleDIETARY_SUPPLEMENT

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

Oral contraceptiveDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 39 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Studio Medico Anteo

Terni, TR, Italy

Outcomes

Primary Outcomes

cellulite

patients' self-assessed evaluation through a questionnaire

Time frame: Change from baseline cellulite status at 3 months

water retention

Bioelectrical impedance analysis (BIA)

Time frame: Change from baseline extracellular body water content at 3 months

Secondary Outcomes

mood

patients' self-assessed evaluation through a questionnaire

Time frame: Change from baseline mood at 3 months

Data from ClinicalTrials.gov

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