Contraception
Conditions
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.
Interventions
DIETARY_SUPPLEMENTZyxelle
Patients in the study group receive Zyxelle dietary supplement along with the oral contraceptive
DRUGOral contraceptive
Patients in the study group receive daily dose of estroprogestinic oral contraceptive
Sponsors
Lo.Li.Pharma s.r.l
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Control group: oral contraceptive Study group: oral contraceptive + specific supplement
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| mood | Change from baseline mood at 3 months | patients' self-assessed evaluation through a questionnaire |
Countries
Italy
Outcome results
None listed