Evaluation of GNR034 cream versus lactic acid cream to compare the effectiveness and safety in treating women diagnosed with a vaginal yeast infection
| ISRCTN | ISRCTN12908359 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12908359 |
| EudraCT/CTIS number | 2014-005315-16 |
| Secondary identifying numbers | CNG2711-14 |
- Submission date
- 16/11/2021
- Registration date
- 08/12/2021
- Last edited
- 26/11/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Vaginal yeast infection is also known as vaginal candidiasis or genital candidiasis, or vulvovaginal candidiasis (VVC). It is an infection involving a type of fungus, or yeast. The fungus that is most commonly associated with a vaginal yeast infection is called Candida albicans. This fungus is responsible for up to 92% of all cases, with the remainder due to other species of Candida. These fungi can be found all over the body. They are normally present in warm and moist areas of the body. Some past studies have shown that between 20% to 50% of all women are normally carrying yeast in the vagina. Thus they do not have any symptoms. It seems that problems occur when Candida albicans in the vagina multiplies to the point of infection. Such an infection can cause vaginal inflammation, irritation, odour, discharge, and itching. C. albicans is kept from growing out of control by other types of bacteria that live naturally in the vagina. If the balance of these microorganisms becomes upset, C. albicans may be allowed to grow uncontrollably and lead to symptoms. The use of certain medications like antibiotics, changes in hormone levels, or certain diseases are examples of factors that can allow a vaginal yeast infection to develop. Vaginal yeast infections are very common. Almost 75% of women develop a yeast infection during their lives. A vaginal yeast infection is not considered a sexually-transmitted disease (STD). However, 12% to 15% of men develop symptoms such as itching and penile rash after sexual contact with an infected partner. Under normal circumstances, a vaginal yeast infection is not serious and can be treated with medications. In very rare cases, a yeast infection can lead to systemic Candida disease, which is fatal in 75% of people who develop this major complication. This occurs when the infection spreads throughout the body via the bloodstream. Women with weakened immune systems are most susceptible to this type of complication. The aim of this study is to evaluate the safety and effectiveness of GNR034 (Ginuril® cream) versus lactic acid administered by the vaginal route in women affected by a vaginal yeast infection and who are starting treatment with clotrimazole vaginal tablets.
Who can participate?
Caucasian women between 18 and 50 years of age with vaginal infections
What does the study involve?
Participants are randomly allocated to administer either GNR034 (Ginuril® cream) or lactic acid once per day for 7 consecutive days by the vaginal route according to the approved leaflet. Participants attended three visits: at the start of the study (Visit 1), Visit 2 after 3 days of treatment, and an end of study visit (Visit 3), 7 days after starting treatment.
What are the possible benefits and risks of participating?
The benefits of participation in this study are a free diagnosis and medical check and free treatment for vaginal infection. There were no side effects reported of the use of Ginuril during preclinical studies.
Where is the study run from?
Novintethical Pharma SA (Switzerland)
When is the study starting and how long is it expected to run for?
May 2015 to June 2016
Who is funding the study?
Novintethical Pharma SA (Switzerland)
Who is the main contact?
Alina Iordache
alina.iordache@cebis-int.com
Contact information
Scientific
222 Calea Plevnei 3rd Floor
Bucharest
060016
Romania
 ORCID ID |
0000-0002-5931-0463 |
|---|---|
| Phone | +40 (0)737 640 721 |
| alina.iordache@cebis-int.com |
Study information
| Study design | Double-blind parallel randomized multicenter study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A double-blind, parallel, randomized, multicenter study to evaluate the safety and efficacy of NR034 (Ginuril®) versus lactic acid administered as co-adjuvant by vaginal route in women affected by a vaginal yeast infection and who are initiating treatment with clotrimazole vaginal tablets |
| Study acronym | AVANTAGE |
| Study objectives | This was a double-blind, parallel, randomized, multicenter study to evaluate the safety and efficacy of GNR034 (Ginuril®) versus lactic acid administered as coadjuvant by vaginal route in women affected by a vaginal yeast infection and who are initiating treatment with clotrimazole vaginal tablets. |
| Ethics approval(s) | Approved 05/05/2015, National Agency of Medicine and Medical Devices of Romania (Stefan Cel Mare 19-21 Road, District 2, Bucharest, Romania; +40 (0)212102880; comisia.bioetica@adsm.ro), ref: 2DM/22.05.2015 |
| Health condition(s) or problem(s) studied | Vaginal infection |
| Intervention | The participants are assigned randomly to a study treatment based on a computer randomized 1:1 scheme which generates the code of the treatment that is allocated to the specific patient. Participants are instructed to administer product A or B once per day for 7 consecutive days. The treatments (Product A or Product B) are administered by the vaginal route according to the approved leaflet. One group receives GNR034 (Ginuril® cream) and the other group lactic acid. Patients attend three visits: 1. Baseline visit (Visit 1) 2. Visit 2 after 3 days of treatment 3. End of study visit (Visit 3), 7 days after beginning treatment |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | GNR034 (Ginuril®), lactic acid |
| Primary outcome measure | 1. Safety: occurrence and classification of adverse events (AE)/serious adverse events (SAE)/suspected unexpected serious adverse reactions (SUSAR), recorded using patient diaries on days 1, 3 and 7 2. Occurrence of undesirable systemic or local effects reported by the patient or observed by the physician during the whole study period, recorded on days 1, 3 and 7 |
| Secondary outcome measures | Observed by self-report (patient diary) and by the physician during gynecological examinations: 1. Mycological count on days 1, 3 and 7 of treatment 2. Clinical symptoms: 2.1. Itching evaluated using the Scott-Huskisson scale on days 1, 2, 3, 4, 5, 6, 7 2.2. Leucorrhoea evaluated on days 1, 2, 3, 4, 5, 6, 7 2.3. Dysuria evaluated on days 1, 2, 3, 4, 5, 6, 7 2.4. Dyspareunia evaluated on days 1, 2, 3, 4, 5, 6, 7 3. Vaginal pH measured on days 1, 3, 7 |
| Overall study start date | 05/05/2015 |
| Completion date | 24/06/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Female |
| Target number of participants | 42 |
| Total final enrolment | 42 |
| Key inclusion criteria | 1. Females between 18 and 50 years of age 2. Caucasian race 3. Suffering from vaginal yeast infection 4. Initiating therapy with clotrimazole vaginal tablets for 3 days 5. Signed informed consent form |
| Key exclusion criteria | 1. Pregnant women or breastfeeding 2. Unwilling to sign the informed consent form 3. Allergy to one of the product ingredients |
| Date of first enrolment | 11/11/2015 |
| Date of final enrolment | 17/06/2016 |
Locations
Countries of recruitment
- Romania
Study participating centres
Clinicilor Street 3-5
Cluj-Napoca
400000
Romania
Vitan-Bârzești Street, 13
Bucharest
042122
Romania
Brasov
500148
Romania
Bucharest
14452
Romania
Galati
800578
Romania
Sponsor information
Industry
Via Pian Scairolo, 11
Lugano
6900
Switzerland
| Phone | +41 (0)91 234 15 72 |
|---|---|
| info@novintethical.com | |
| Website | http://www.novintethical.com/ |
"ROR" |
https://ror.org/05ypvb778 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 15/05/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. Additional documents will be provided at a later point on request. |
| IPD sharing plan | The data will be collected under the study confidentiality and for study purposes only, according to the approved informed consent form. The study data will be archived according to the sponsor requirements and local regulatory requirements. |
Editorial Notes
24/11/2021: Trial's existence confirmed by the National Agency of Medicine and Medical Devices of Romania.
