Specific Supplementation in Counteracting the Adverse Effects of Oral Contraceptives
Not Applicable
Withdrawn
- 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- WITHDRAWN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
Inclusion Criteria
- Body Mass Index: 18-30 Kg/m2;
- Prescription for COC treatment
Exclusion Criteria
- 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
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms does Zyxelle target to counteract oral contraceptive side effects?
How does Zyxelle supplementation compare to standard-of-care in reducing OC-related adverse effects?
Are there specific biomarkers that predict Zyxelle's efficacy in mitigating OC-induced metabolic changes?
What adverse events are associated with Zyxelle in combination with combined oral contraceptives?
What are the competitive dietary supplements targeting estrogen metabolism in contraceptive users?
Trial Locations
- Locations (1)
Studio Medico Anteo
🇮🇹Terni, TR, Italy
Studio Medico Anteo🇮🇹Terni, TR, Italy