Healthy WomenPhase 1NCT02720783
Tolerability and Pharmacokinetic Study of Econazole Nitrate Plus Benzydamine HCl Vaginal Pessary
A Phase 1 study testing Econazole nitrate 150 mg plus Benzydamine HCl 6 mg vaginal pessary in people with Healthy Women, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 1 site in Switzerland.
Trial summary
The primary objective of the study is to evaluate the local tolerability of the new Econazole/Benzydamine pessary, in comparison with Econazole and Benzydamine stand-alone products and placebo. Pharmacokinetics of the study products after single and multiple applications o.d. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Women
- What is being tested?
- Econazole nitrate 150 mg plus Benzydamine HCl 6 mg vaginal pessary
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Mar 2016to 12 Oct 2016
- Phase
- Phase 1
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent: signed written informed consent before inclusion in the study.
- Sex and age: healthy women, aged 18-55 years old inclusive.
- Body Mass Index (BMI): 18.5-30 kg/m2 inclusive.
- Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest (sitting position).
- Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study.
- Sexual abstinence: agreement to sexual abstinence during the study.
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- Contraception and fertility: women of child-bearing potential, even if sexually abstinent during the study as required by the study inclusion criteria, must be using at least one reliable method of contraception, as follows:
- hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit;
- a non-hormonal intrauterine device [IUD] for at least 2 months before the screening visit;
- a male sexual partner who agrees to use a male condom;
- a vasectomised sexual partner. Female participants of non-child-bearing potential will be admitted. For all female subjects, pregnancy test result must be negative at screening and on day 1.
- PAP test: negative PAP test result (i.e. normal PAP test result without atypical cells) at screening.
Who cannot join
- ECG (12-leads, supine position): clinically significant abnormalities.
- Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study as judged by the Investigator.
- Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness.
- Allergies: ascertained or presumptive hypersensitivity (including allergies) to the active ingredients (econazole nitrate and/or benzydamine HCl) and/or formulations' excipients or related drugs, e.g. other azoles; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study.
- Diseases: relevant history of renal, hepatic, gastrointestinal, genitourinary, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study or affect the subject's safety.
- Genitourinary diseases: presence of any specific genitourinary symptoms detected at visit 2 with the relevant questionnaire (genitourinary symptoms questionnaire).
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- Infection history: history of bacterial urinary tract or bacterial or fungal vaginal infections for 3 weeks before the screening visit.
- Systemic and/or local infections: bacterial or fungal infections that may interfere with the aim of the study or affect the subject's safety. If the results of the microbiological analyses concerning Ureaplasma/Mycoplasma and Actinomyces are positive, the subject can be enrolled only if asymptomatic and without any clinical evidence (gynaecological visit, PAP test and vaginal pH measurement) of vaginal infections.
- Gynaecological findings: clinically significant abnormal findings at the gynaecological visit performed by the study Gynaecologist.
- Mucosa conditions: altered mucosa conditions affecting the site of insertion (e.g. open lesions or other).
- Habits: use of vaginal detergents, soaps and washes that, in the Investigator's opinion, may have an influence on vaginal pH and/or change the vaginal flora.
- Medications: any medication (topical or systemic), including over the counter, herbal medication, topical drugs on the application area, and anticoagulants, such as warfarin, acenocoumarol and rivaroxaban, for 2 weeks before the start of the study. Hormonal contraceptives and hormonal replacement therapies are allowed. Paracetamol will be allowed as a counter-measure for adverse events, on a case by case basis, if deemed appropriate by the Investigator.
- Investigative drug studies: participation in the evaluation of any drug for 3 months before this study, calculated from the first day of the month following the last visit of a previous study and the first day of the present study (date of the informed consent signature).
- Blood donation: blood donations for 3 months before this study.
- Drug, alcohol, caffeine, tobacco: history of drug, alcohol (> 1 drink/day, defined according to USDA Dietary Guidelines 2010), tobacco (≥ 10 cigarettes/day) or caffeine (> 5 cups coffee/tea/day) abuse.
- Diet: Abnormal diets (< 1600 or > 3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians.
- Pregnancy: positive or missing pregnancy test at screening or day 1, pregnant or lactating women or females of child-bearing potential not following adequate contraceptive procedures.
- Non-compliance: subjects suspected to have a high potential for non-compliance to the study procedures according to the Investigator's judgement, including non-compliance to sexual abstinence during the study.
- Drug test (cocaine, amphetamine, methamphetamine, cannabinoids, opiates and ecstasy): positive result at the drug test at screening.
- Alcohol test: positive alcohol breath test at day 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of a Novel Antimycotic Vaginal Pessary Formulation (Econazole Nitrate 150 mg + Benzydamine HCl 6 mg) Administered Once Daily for 3 Days to Healthy Women
The primary objective of the study is to evaluate the local tolerability of the new Econazole/Benzydamine pessary, in comparison with Econazole and Benzydamine stand-alone products and placebo. Pharmacokinetics of the study products after single and multiple applications o.d. for 3 days, overall local and general tolerability, safety and comfort of use will also be evaluated.
- Conditions
- Healthy Women
- Being tested
- Econazole nitrate 150 mg plus Benzydamine HCl 6 mg vaginal pessary, Placebo plus Econazole nitrate 150 mg vaginal pessary, Placebo plus Benzydamine HCl 6 mg vaginal pessary, Placebo vaginal pessary
- Keywords
- Pharmacokinetics, Econazole nitrate 150mg, Benzydamine HCl 6mg, Vaginal pessary, Tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Econazole nitrate 150 mg plus Benzydamine HCl 6 mg vaginal pessaryDrug
Econazole nitrate 150 mg plus Benzydamine HCl 6 mg vaginal pessary
Placebo plus Econazole nitrate 150 mg vaginal pessaryDrug
Placebo plus Benzydamine HCl 6 mg vaginal pessaryDrug
Placebo vaginal pessaryDrug
| Study group | Role | What they receive |
|---|---|---|
| Econazole nitrate 150 mg plus Benzydamine HCl 6 mg | Experimental | One vaginal pessary (2.7 g) of Econazole nitrate 150 mg plus Benzydamine HCl 6 mg, once daily, for 3 consecutive days Receives: Drug: Econazole nitrate 150 mg plus Benzydamine HCl 6 mg vaginal pessary |
| Placebo plus Econazole nitrate 150 mg | Active comparator | One vaginal pessary (2,7 g) of Placebo plus Econazole nitrate 150 mg, once daily, for 3 consecutive days Receives: Drug: Placebo plus Econazole nitrate 150 mg vaginal pessary |
| Placebo plus Benzydamine HCl 6 mg | Active comparator | One vaginal pessary (2,7 g) of Placebo plus Benzydamine HCl 6 mg, once daily, for 3 consecutive days Receives: Drug: Placebo plus Benzydamine HCl 6 mg vaginal pessary |
| Placebo | Placebo comparator | One vaginal pessary (2.7 g) of Placebo, once daily, for 3 consecutive days Receives: Drug: Placebo vaginal pessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Adverse Drug Reactions (ADRs)
Occurence of local ADRs reported by the subjects as 1-3 scores for pruritus, burning sensation, pain, stinging and dryness; occurrence of all the other local Adverse Events (AEs) referred by the subjects; occurrence of all the local ADRs revealed by the Investigator/ Gynaecologist
Measured: Up to 7 days after administration
Secondary outcomes (6)
Econazole (free base), benzydamine (free base) and benzydamine N-oxide (free base) plasma concentrations
Measured: At pre-dose (0), 1, 2, 3, 4, 6, 8, 12, 24 hours after the first (day 1) and the last dose (day 3)
Area under the plasma concentration versus time curve [AUC(0-t)] of econazole (free base), benzydamine (free base) and benzydamine N-oxide (free base)
Measured: At pre-dose (0), 1, 2, 3, 4, 6, 8, 12, 24 hours after the first (day 1) and the last dose (day 3)
Overall local tolerability assessment scale
Measured: At final visit (from day 5 to day 8)
Occurrence of all AEs and ADRs
Measured: 5-8 days
Change from screening in laboratory parameters
Measured: From screening (from day -21 to day -7) at final visit (from day 5 to day 8)
Questionnaire for the comfort of use
Measured: At final visit (from day 5 to day 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2016 (estimated)
- Study start4 Mar 2016
- Primary completion12 Oct 2016
- Study completion12 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy WomenStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cross Research S.A.
- Responsible party
- Sponsor
- Investigators
- Milko Radicioni, MD, Principal investigator, CROSS Research S.A. Phase I Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720783
- Sponsor's protocol ID
- 030(4C)HO15323
- Other IDs
- CRO-PK-15-302
- Status last verified
- Feb 2017
- First submitted
- 22 Mar 2016
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Di Stefano AFD, Radicioni MM, Vaccani A, Caccia G, Focanti F, Salvatori E, Pelacchi F, Picollo R, Rosignoli MT, Olivieri S, Bovi G, Comandini A. Phase I Study in Healthy Women of a Novel Antimycotic Vaginal Ovule Combining Econazole and Benzydamine. Infect Dis Obstet Gynecol. 2020 May 2;2020:7201840. doi: 10.1155/2020/7201840. eCollection 2020.
PubMed 32410819
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of a Novel Antimycotic Vaginal Pessary Formulation (Econazole Nitrate 150 mg + Benzydamine HCl 6 mg) Administered Once Daily for 3 Days to Healthy Women
- ClinicalTrials.gov ID
- NCT02720783
- Acronym / sponsor ID
- 030(4C)HO15323
- Conditions
- Healthy Women
- Keywords
- Pharmacokinetics, Econazole nitrate 150mg, Benzydamine HCl 6mg, Vaginal pessary, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.AIndustry (pharma, biotech, devices)
- Collaborators
- Cross Research S.A.
- Study start
- 4 Mar 2016 (actual)
- Primary completion
- 12 Oct 2016 (actual)
- Study completion
- 12 Oct 2016 (actual)
- First posted
- 28 Mar 2016 (estimated)
- 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.
The primary objective of the study is to evaluate the local tolerability of the new Econazole/Benzydamine pessary, in comparison with Econazole and Benzydamine stand-alone products and placebo. Pharmacokinetics of the study products after single and multiple applications o.d. for 3 days, overall local and general tolerability, safety and comfort of use will also be evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Econazole nitrate 150 mg plus Benzydamine HCl 6 mg | Experimental | Drug: Econazole nitrate 150 mg plus Benzydamine HCl 6 mg vaginal pessaryOne vaginal pessary (2.7 g) of Econazole nitrate 150 mg plus Benzydamine HCl 6 mg, once daily, for 3 consecutive days |
| Placebo plus Econazole nitrate 150 mg | Active comparator | Drug: Placebo plus Econazole nitrate 150 mg vaginal pessaryOne vaginal pessary (2,7 g) of Placebo plus Econazole nitrate 150 mg, once daily, for 3 consecutive days |
| Placebo plus Benzydamine HCl 6 mg | Active comparator | Drug: Placebo plus Benzydamine HCl 6 mg vaginal pessaryOne vaginal pessary (2,7 g) of Placebo plus Benzydamine HCl 6 mg, once daily, for 3 consecutive days |
| Placebo | Placebo comparator | Drug: Placebo vaginal pessaryOne vaginal pessary (2.7 g) of Placebo, once daily, for 3 consecutive days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Informed consent: signed written informed consent before inclusion in the study.
- Sex and age: healthy women, aged 18-55 years old inclusive.
- Body Mass Index (BMI): 18.5-30 kg/m2 inclusive.
- Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest (sitting position).
- Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study.
Key exclusion criteria (20 listed)
- ECG (12-leads, supine position): clinically significant abnormalities.
- Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study as judged by the Investigator.
- Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness.
- Allergies: ascertained or presumptive hypersensitivity (including allergies) to the active ingredients (econazole nitrate and/or benzydamine HCl) and/or formulations' excipients or related drugs, e.g. other azoles; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study.
- Diseases: relevant history of renal, hepatic, gastrointestinal, genitourinary, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study or affect the subject's safety.
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 |
|---|---|---|
| Econazole nitrate 150 mg plus Benzydamine HCl 6 mg vaginal pessaryEconazole nitrate 150 mg plus Benzydamine HCl 6 mg vaginal pessary | Drug | Econazole nitrate 150 mg plus Benzydamine HCl 6 mg |
| Placebo plus Econazole nitrate 150 mg vaginal pessary | Drug | Placebo plus Econazole nitrate 150 mg |
| Placebo plus Benzydamine HCl 6 mg vaginal pessary | Drug | Placebo plus Benzydamine HCl 6 mg |
| Placebo vaginal pessary | Drug | Placebo |
Primary outcome
Local Adverse Drug Reactions (ADRs)
Time frame: Up to 7 days after administration
Occurence of local ADRs reported by the subjects as 1-3 scores for pruritus, burning sensation, pain, stinging and dryness; occurrence of all the other local Adverse Events (AEs) referred by the subjects; occurrence of all the local ADRs revealed by the Investigator/ Gynaecologist
6 secondary outcomes
Econazole (free base), benzydamine (free base) and benzydamine N-oxide (free base) plasma concentrations
Time frame: At pre-dose (0), 1, 2, 3, 4, 6, 8, 12, 24 hours after the first (day 1) and the last dose (day 3)
Area under the plasma concentration versus time curve [AUC(0-t)] of econazole (free base), benzydamine (free base) and benzydamine N-oxide (free base)
Time frame: At pre-dose (0), 1, 2, 3, 4, 6, 8, 12, 24 hours after the first (day 1) and the last dose (day 3)
Overall local tolerability assessment scale
Time frame: At final visit (from day 5 to day 8)
Occurrence of all AEs and ADRs
Time frame: 5-8 days
Change from screening in laboratory parameters
Time frame: From screening (from day -21 to day -7) at final visit (from day 5 to day 8)
Questionnaire for the comfort of use
Time frame: At final visit (from day 5 to day 8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Derived from this study: PubMed 32410819Di Stefano AFD, Radicioni MM, Vaccani A, Caccia G, Focanti F, Salvatori E, Pelacchi F, Picollo R, Rosignoli MT, Olivieri S, Bovi G, Comandini A. Phase I Study in Healthy Women of a Novel Antimycotic Vaginal Ovule Combining Econazole and Benzydamine. Infect Dis Obstet Gynecol. 2020 May 2;2020:7201840. doi: 10.1155/2020/7201840. eCollection 2020.
- 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.
Milko Radicioni, MD principal investigator
CROSS Research S.A. Phase I Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Econazole nitrate 150 mg plus Benzydamine HCl 6 mg vaginal pessary in people with Healthy Women, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 1 site in Switzerland.
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 12 inclusion and 20 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: finished, as of the sponsor's last update on 7 Feb 2017. 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 Switzerland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Local Adverse Drug Reactions (ADRs) (time frame: Up to 7 days after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02720783, which also lists 1 linked publication.
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 7 Feb 2017; AzTrials last refreshed its copy on 8 Nov 2026.