ContraceptionNCT07071389
Specific Supplementation in Counteracting the Adverse Effects of Oral Contraceptives
A study testing Zyxelle and Oral contraceptive in people with Contraception, run by Lo.Li.Pharma s.r.l at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Zyxelle and Oral contraceptive
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2018to 21 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index: 18-30 Kg/m2;
- Prescription for COC treatment
Who cannot join
- diabetes;
- previous or existing breast pathologies;
- hypertension;
- obesity;
- smoking habits;
- cardiovascular disorders
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Contraception
- Being tested
- Zyxelle, Oral contraceptive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZyxelleDietary supplement
Patients in the study group receive Zyxelle dietary supplement along with the oral contraceptive
Oral contraceptiveDrug
Patients in the study group receive daily dose of estroprogestinic oral contraceptive
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients prescribed estroprogestinic oral contraceptive Receives: Drug: Oral contraceptive |
| Study group | Experimental | Patients prescribed estroprogestinic oral contraceptive were treatedwith Zyxelle supplement Receives: Dietary Supplement: Zyxelle; Drug: Oral contraceptive |
What is being measured
The primary outcome is the main question the study is designed to answer.
cellulite
patients' self-assessed evaluation through a questionnaire
Measured: Change from baseline cellulite status at 3 months
water retention
Bioelectrical impedance analysis (BIA)
Measured: Change from baseline extracellular body water content at 3 months
Secondary outcomes (1)
mood
patients' self-assessed evaluation through a questionnaire
Measured: Change from baseline mood at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start8 Jan 2018
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
Why it stopped: The investigators were not able to recruit elegible patients and decided to halt the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control group: oral contraceptive Study group: oral contraceptive + specific supplement
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lo.Li.Pharma s.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071389
- Sponsor's protocol ID
- 000152
- Status last verified
- Apr 2019
- First submitted
- 3 Apr 2019
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific Supplementation in Counteracting the Adverse Effects of Oral Contraceptives
- ClinicalTrials.gov ID
- NCT07071389
- Acronym / sponsor ID
- 000152
- Conditions
- Contraception
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The investigators were not able to recruit elegible patients and decided to halt the trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lo.Li.Pharma s.r.lIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Control group: oral contraceptive Study group: oral contraceptive + specific supplement
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Oral contraceptivePatients prescribed estroprogestinic oral contraceptive |
| Study group | Experimental | Dietary Supplement: Zyxelle, Drug: Oral contraceptivePatients prescribed estroprogestinic oral contraceptive were treatedwith Zyxelle supplement |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body Mass Index: 18-30 Kg/m2;
- Prescription for COC treatment
Key exclusion criteria (6 listed)
- diabetes;
- previous or existing breast pathologies;
- hypertension;
- obesity;
- smoking habits;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZyxellePatients in the study group receive Zyxelle dietary supplement along with the oral contraceptive | Dietary supplement | Study group |
| Oral contraceptivePatients in the study group receive daily dose of estroprogestinic oral contraceptive | Drug | Control group, Study group |
Primary outcome
cellulite
Time frame: Change from baseline cellulite status at 3 months
patients' self-assessed evaluation through a questionnaire
water retention
Time frame: Change from baseline extracellular body water content at 3 months
Bioelectrical impedance analysis (BIA)
1 secondary outcome
mood
Time frame: Change from baseline mood at 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zyxelle and Oral contraceptive in people with Contraception, run by Lo.Li.Pharma s.r.l at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cellulite (time frame: Change from baseline cellulite status at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.