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Specific Supplementation in Counteracting the Adverse Effects of Oral Contraceptives

Not Applicable
Withdrawn
Conditions
Contraception
Interventions
Drug: Oral contraceptive
Dietary Supplement: Zyxelle
Registration Number
NCT07071389
Lead Sponsor
Lo.Li.Pharma s.r.l
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
WITHDRAWN
Sex
Female
Target Recruitment
Not specified
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Control groupOral contraceptivePatients prescribed estroprogestinic oral contraceptive
Study groupZyxellePatients prescribed estroprogestinic oral contraceptive were treatedwith Zyxelle supplement
Study groupOral contraceptivePatients prescribed estroprogestinic oral contraceptive were treatedwith Zyxelle supplement
Primary Outcome Measures
NameTimeMethod
celluliteChange from baseline cellulite status at 3 months

patients' self-assessed evaluation through a questionnaire

water retentionChange from baseline extracellular body water content at 3 months

Bioelectrical impedance analysis (BIA)

Secondary Outcome Measures
NameTimeMethod
moodChange from baseline mood at 3 months

patients' self-assessed evaluation through a questionnaire

Trial Locations

Locations (1)

Studio Medico Anteo

🇮🇹

Terni, TR, Italy

Studio Medico Anteo
🇮🇹Terni, TR, Italy

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