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The investigators were not able to recruit elegible patients and decided to halt the trial.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Patients prescribed estroprogestinic oral contraceptive |
|
| Study group | Experimental | Patients prescribed estroprogestinic oral contraceptive were treatedwith Zyxelle supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zyxelle | Dietary Supplement | Patients in the study group receive Zyxelle dietary supplement along with the oral contraceptive |
|
| Measure | Description | Time Frame |
|---|---|---|
| cellulite | patients' self-assessed evaluation through a questionnaire | Change from baseline cellulite status at 3 months |
| water retention | Bioelectrical impedance analysis (BIA) | Change from baseline extracellular body water content at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| mood | patients' self-assessed evaluation through a questionnaire | Change from baseline mood at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Studio Medico Anteo | Terni | TR | 05100 | Italy |
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| ID | Term |
|---|---|
| D003276 | Contraceptives, Oral |
| ID | Term |
|---|---|
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
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Control group: oral contraceptive Study group: oral contraceptive + specific supplement
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| Oral contraceptive | Drug | Patients in the study group receive daily dose of estroprogestinic oral contraceptive |
|
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |