Specific Supplementation in Counteracting the Adverse Effects of Oral Contraceptives
- Conditions
- Contraception
- Interventions
- Drug: Oral contraceptiveDietary 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- WITHDRAWN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
- Body Mass Index: 18-30 Kg/m2;
- Prescription for COC treatment
- diabetes;
- previous or existing breast pathologies;
- hypertension;
- obesity;
- smoking habits;
- cardiovascular disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Oral contraceptive Patients prescribed estroprogestinic oral contraceptive Study group Zyxelle Patients prescribed estroprogestinic oral contraceptive were treatedwith Zyxelle supplement Study group Oral contraceptive Patients prescribed estroprogestinic oral contraceptive were treatedwith Zyxelle supplement
- Primary Outcome Measures
Name Time Method cellulite Change from baseline cellulite status at 3 months patients' self-assessed evaluation through a questionnaire
water retention Change from baseline extracellular body water content at 3 months Bioelectrical impedance analysis (BIA)
- Secondary Outcome Measures
Name Time Method mood Change from baseline mood at 3 months patients' self-assessed evaluation through a questionnaire
Related Research Topics
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Trial Locations
- Locations (1)
Studio Medico Anteo
🇮🇹Terni, TR, Italy
Studio Medico Anteo🇮🇹Terni, TR, Italy