HealthyPhase 1NCT02713893
Tolerability and Pharmacokinetic Study of Econazole Nitrate and Benzydamine HCl Intravaginal Cream
A Phase 1 study testing Econazole nitrate 1% plus Benzydamine HCl 0.12% intravaginal cream in people with Healthy, 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 local tolerability of the new Econazole/Benzydamine product, in comparison with the Econazole and Benzydamine stand-alone products and placebo. 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
- What is being tested?
- Econazole nitrate 1% plus Benzydamine HCl 0.12% intravaginal cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2015to 15 Jun 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: females, 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;
Show all 12Show fewer
- Contraception and fertility: women of child-bearing potential, even if sexual 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 at each scheduled evaluation;
- PAP test: negative result at PAP test (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;
- Allergy: ascertained or presumptive hypersensitivity (including allergies) to the active ingredients (econazole and/ or benzydamine) 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 disease: presence of any specific genitourinary symptoms detected at Visit 2 with the relevant questionnaire (genitourinary symptoms questionnaire);
Show all 20Show fewer
- Infection history: history of bacterial urinary tract or bacterial and fungal vaginal infections for 3 weeks before the screening visit;
- Infections: bacterial or fungal infections (microbiology assessment);
- Gynaecological findings: clinically significant abnormal findings at the gynaecological visit performed by the study gynaecologist;
- Mucosa conditions: altered mucosa conditions affecting the site of application (e.g. open lesion or other);
- Vaginal conditions: 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 and acenocoumarol, 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 Intravaginal Antimycotic Cream (Econazole Nitrate 1% Plus Benzydamine HCl 0.12%) Administered Once Daily for 15 Days to Healthy Women
The primary objective of the study is to evaluate local tolerability of the new Econazole/Benzydamine product, in comparison with the Econazole and Benzydamine stand-alone products and placebo. Pharmacokinetics of the study products after single and repeated applications once a day for 15 days, safety of the investigational products and comfort of use will also be evaluated as secondary objectives.
- Conditions
- Healthy
- Being tested
- Econazole nitrate 1% plus Benzydamine HCl 0.12% intravaginal cream, Placebo plus Econazole nitrate 1% intravaginal cream, Placebo plus Benzydamine HCl 0.12% intravaginal cream, Placebo intravaginal cream
- Keywords
- Pharmacokinetics, Econazole nitrate 1%, Benzydamine HCl 0.12%, Intravaginal cream, Antimycotic, Tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Econazole nitrate 1% plus Benzydamine HCl 0.12% intravaginal creamDrug
Placebo plus Econazole nitrate 1% intravaginal creamDrug
Placebo plus Benzydamine HCl 0.12% intravaginal creamDrug
Placebo intravaginal creamDrug
| Study group | Role | What they receive |
|---|---|---|
| Econazole nitrate 1% plus Benzydamine HCl 0.12% | Experimental | 5 grams of Econazole nitrate 1% plus Benzydamine HCl 0.12% intravaginal cream, once daily for 15 consecutive days Receives: Drug: Econazole nitrate 1% plus Benzydamine HCl 0.12% intravaginal cream |
| Placebo plus Econazole nitrate 1% | Active comparator | 5 grams of Placebo plus Econazole nitrate 1% intravaginal cream, once daily for 15 consecutive days Receives: Drug: Placebo plus Econazole nitrate 1% intravaginal cream |
| Placebo plus Benzydamine HCl 0.12% | Active comparator | 5 grams of Placebo plus Benzydamine HCl 0.12% intravaginal cream, once daily for 15 consecutive days. Receives: Drug: Placebo plus Benzydamine HCl 0.12% intravaginal cream |
| Placebo | Placebo comparator | 5 grams of Placebo intravaginal cream, once daily for 15 consecutive days. Receives: Drug: Placebo intravaginal cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Adverse Events (AEs)
Occurrence of local Adverse Events (AEs) reported in the subject's diary as 1-3 scores for pruritus, burning sensation, pain, stinging, dryness; occurrence of all the other local AEs referred by the subject; occurrence of all the local Adverse Drug Reactions (ADRs) revealed by the Investigator
Measured: Up to 7 days after administration
Secondary outcomes (10)
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 (days 1-2) and the last dose (days 15-16) and at pre-dose (0) on day 6±1, day 9±1 and day 12±1
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 (days 1-2) and the last dose (days 15-16) and at pre-dose (0) on day 6±1, day 9±1 and day 12±1
Treatment Emergent Adverse Events (TEAEs)
Measured: 15-16 days
Change from screening in vital signs
Measured: From screening (from day -21 to day -7) at days 1 and 15 at pre-dose (0), 12 and 24 hours post-dose
Change from screening in 12-leads ECG
Measured: From screening (from day -21 to day -7) at final visit (from day 17 to day 20)
Change from screening in laboratory parameters
Measured: From screening (from day -21 to day -7) and at final visit (from day 17 to day 20)
Change from screening in vaginal pH measurement
Measured: From screening (from day -21 to day -7), before the application on days 1, 2, 15, on days 6±1, 9±1, 12±1 at final visit (from day 17 to day 20)
Change from screening in gynaecological examination findings
Measured: From screening (from day -21 to day -7) at final visit (from day 17 to day 20)
Overall tolerability assessment scale
Measured: At final visit (from day 17 to day 20)
Questionnaire for the comfort of use
Measured: At final visit (from day 17 to day 20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startSep 2015
- Primary completionJun 2016
- Study completion15 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 48 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.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713893
- Sponsor's protocol ID
- 030(4A)HO14387
- Other IDs
- CRO-PK-14-289
- Status last verified
- Aug 2016
- First submitted
- 7 Aug 2015
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of a Novel Intravaginal Antimycotic Cream (Econazole Nitrate 1% Plus Benzydamine HCl 0.12%) Administered Once Daily for 15 Days to Healthy Women
- ClinicalTrials.gov ID
- NCT02713893
- Acronym / sponsor ID
- 030(4A)HO14387
- Conditions
- Healthy
- Keywords
- Pharmacokinetics, Econazole nitrate 1%, Benzydamine HCl 0.12%, Intravaginal cream, Antimycotic, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.AIndustry (pharma, biotech, devices)
- Collaborators
- Cross Research S.A.
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- 15 Jun 2016 (actual)
- First posted
- 21 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 local tolerability of the new Econazole/Benzydamine product, in comparison with the Econazole and Benzydamine stand-alone products and placebo. Pharmacokinetics of the study products after single and repeated applications once a day for 15 days, safety of the investigational products and comfort of use will also be evaluated as secondary objectives.
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 1% plus Benzydamine HCl 0.12% | Experimental | Drug: Econazole nitrate 1% plus Benzydamine HCl 0.12% intravaginal cream5 grams of Econazole nitrate 1% plus Benzydamine HCl 0.12% intravaginal cream, once daily for 15 consecutive days |
| Placebo plus Econazole nitrate 1% | Active comparator | Drug: Placebo plus Econazole nitrate 1% intravaginal cream5 grams of Placebo plus Econazole nitrate 1% intravaginal cream, once daily for 15 consecutive days |
| Placebo plus Benzydamine HCl 0.12% | Active comparator | Drug: Placebo plus Benzydamine HCl 0.12% intravaginal cream5 grams of Placebo plus Benzydamine HCl 0.12% intravaginal cream, once daily for 15 consecutive days. |
| Placebo | Placebo comparator | Drug: Placebo intravaginal cream5 grams of Placebo intravaginal cream, once daily for 15 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: females, 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;
- Allergy: ascertained or presumptive hypersensitivity (including allergies) to the active ingredients (econazole and/ or benzydamine) 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 1% plus Benzydamine HCl 0.12% intravaginal cream | Drug | Econazole nitrate 1% plus Benzydamine HCl 0.12% |
| Placebo plus Econazole nitrate 1% intravaginal cream | Drug | Placebo plus Econazole nitrate 1% |
| Placebo plus Benzydamine HCl 0.12% intravaginal cream | Drug | Placebo plus Benzydamine HCl 0.12% |
| Placebo intravaginal cream | Drug | Placebo |
Primary outcome
Local Adverse Events (AEs)
Time frame: Up to 7 days after administration
Occurrence of local Adverse Events (AEs) reported in the subject's diary as 1-3 scores for pruritus, burning sensation, pain, stinging, dryness; occurrence of all the other local AEs referred by the subject; occurrence of all the local Adverse Drug Reactions (ADRs) revealed by the Investigator
10 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 (days 1-2) and the last dose (days 15-16) and at pre-dose (0) on day 6±1, day 9±1 and day 12±1
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 (days 1-2) and the last dose (days 15-16) and at pre-dose (0) on day 6±1, day 9±1 and day 12±1
Treatment Emergent Adverse Events (TEAEs)
Time frame: 15-16 days
Change from screening in vital signs
Time frame: From screening (from day -21 to day -7) at days 1 and 15 at pre-dose (0), 12 and 24 hours post-dose
Change from screening in 12-leads ECG
Time frame: From screening (from day -21 to day -7) at final visit (from day 17 to day 20)
Change from screening in laboratory parameters
Time frame: From screening (from day -21 to day -7) and at final visit (from day 17 to day 20)
Change from screening in vaginal pH measurement
Time frame: From screening (from day -21 to day -7), before the application on days 1, 2, 15, on days 6±1, 9±1, 12±1 at final visit (from day 17 to day 20)
Change from screening in gynaecological examination findings
Time frame: From screening (from day -21 to day -7) at final visit (from day 17 to day 20)
Overall tolerability assessment scale
Time frame: At final visit (from day 17 to day 20)
Questionnaire for the comfort of use
Time frame: At final visit (from day 17 to day 20)
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 17 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
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 1% plus Benzydamine HCl 0.12% intravaginal cream in people with Healthy, 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 17 Jan 2018. 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 Events (AEs) (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?
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 Jan 2018.