Pre- Peri, and Postmenopausal WomenNCT05918848
Tocopherol Acetate Vaginal Administration in Pre-peri and Postmenopausal Women
An observational study of Pre- Peri, and Postmenopausal Women, run by Gemelli Molise Hospital.
Trial summary
The purpose of this non-controlled Investigator Initiated Trail (IIT), with a retrospective design is to evaluate the performance and safety of the vaginal administration of tocopherol acetate (vitamin E) in pre-peri and postmenopausal women. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women only
- Conditions the study is for
- Pre- Peri, and Postmenopausal Women
- What is being tested?
- Filme Gyno-V® Vaginal Ovules
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2023to 30 Jul 2023
- Phase
- Observational
- 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 50 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The patients admitted in the Center for gynecologic visits in the period from January 1st, 2020 to December, 31st, 2022 and found eligible for inclusion in the study.
Who may be able to join
- Women aged ≥ 50 to ≤ 70 years included.
- Premenopause, perimenopause,postmenopause women (according to STRAW criteria)
- Patients able to comply with the requirements for the study and freely willing to provide written informed consent to the retrospectively collection of their data.
Who cannot join
- Malignancy (also leukemic infiltrates) within 5 years prior to day 0 (except for treated basal cell/squamous cell carcinoma of the skin).
- Genital bleeding.
- Oestrogen topical (vaginal) treatment during the study period (it must have been terminated at least 6 months before the beginning of the study).
- Systemic oestrogen therapy during the study period (it must have been terminated at least 6 months before the beginning of the study).
- Patients with any illness, or any other medical condition, that, in the opinion of the Investigator, would compromise the participation or be likely to lead to hospitalisation during the study.
- Clinical evidence of acute infection currently requiring treatment (syphilis, herpes simplex, human papilloma virus, gonorrhoea, chlamydia, lymphogranuloma venereum, etc.); clinical evidence or history of chronic infectious disease (e.g., tuberculosis).
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- Psychosis, schizophrenia, mania, depressive disorders, history of suicide attempt or suicidal ideation, or any other psychiatric illness (except for intermittent anxiety).
- Known allergy to tested medical device (tocopherol day 0.
- Participation in an interventional clinical study or administration of any investigational agents in the 30 days prior to day 0.
- Presence of any clinically significant medical condition judged by the Investigator to preclude the patient's inclusion in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Performance and Safety of Vaginal Administration of Tocopherol Acetate (Vitamin E) in Pre- Peri and Postmenopausal Women
The purpose of this non-controlled Investigator Initiated Trail (IIT), with a retrospective design is to evaluate the performance and safety of the vaginal administration of tocopherol acetate (vitamin E) in pre-peri and postmenopausal women. The main objectives of the study will be the evaluation of the vaginal pH, of the vaginal eubiosis improving the lactobacilli flora and microbiota, and of sign and symptoms of women. The patients were visited at baseline (with the collection of vaginal swabs) and treated with vaginal administration of tocopherol acetate for 14 days. At the end of treatment (final visit) the patients were visited with the collection of vaginal swabs.
Read the detailed description
The vaginal microbiota has a significant bearing on a woman's mental and physical health at every stage of life. A balanced microflora of the vaginal environment (eubiosis) consists of a predominant presence of lactic acid bacteria. Lactobacilli ensure the maintenance of an acidic pH that effectively makes the environment inhospitable to pathogens by preventing infection and protecting the genital tract. At the end of the reproductive period, the reduction of sex hormones, particularly estrogen, results in a decrease in the lactobacillus component with consequent depletion of the vaginal microbiota and increased susceptibility to pathogens. Tocopherol (vitamin E) is an essential human nutrient found mainly in oily fruits. It is a fat-soluble molecule with high antioxidant power. Topically administered, it not only plays a key role in protecting epithelial cell membranes from oxidative damage but is also able to modulate bacterial growth by contributing to pH acidification. The latter feature, in the vaginal canal, creates a favorable environment for the lactobacilli flora, positively affecting the microbial population and thus contributing to the prevention of all those problems related to increased vaginal sensitivity to pathogens during "menopause." In addition, recent data show that vitamin E can counteract the production of biofilm produced by certain pathogens, which has detrimental effects on the homeostasis of the vaginal environment.
The period of observation is from January 1st, 2020 to December, 31st, 2022, while the Data Collection period will be from June, 30th, 2023 to July, 31st, 2023
- Conditions
- Pre- Peri, and Postmenopausal Women
- Being tested
- Filme Gyno-V® Vaginal Ovules
- Keywords
- Premenopause, perimenopause, postmenopause, vaginal eubiosis, lactobacilli flora, microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filme Gyno-V® Vaginal OvulesDevice
Administration of tocopherol (Filme Gyno-V® Vaginal Ovules) for 14 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Acidity measure of vaginal secretions
It is assessed by Investigator during the medical examination using a pH strip (Merck, Darmstadt, Germany) with a range of 4.0 (acidic) to 7.0 (alkaline). The strip is placed on the lateral walls of the vagina to avoid contact with alkaline cervical secretions. The Investigator dip the pH test strip in the vaginal secretion for two seconds. The more acidic the vaginal secretion, the more red the strip turns, and the more alkaline the vaginal secretion, the more blue the strip turns. This provides a semiquantitative measure of pH by visually comparing the four reaction zones on the test strip to the areas of the colour scale. pH measurement serves as an indicator of the vaginal environment and the balance of microorganisms present.
Measured: 14 days
Secondary outcomes (9)
Rate of vaginal mucosa dryness
Change from baseline to 14 days assessed by the Investigator during the medical examination using a 10 cm visual analogue scale (VAS) where 0 is no dryness, and 10 is the maximum dryness.
Measured: 14 days
Rate of vaginal mucosal integrity
Change from baseline to 14 days assessed by the Investigator during the medical examination and scored by an ordinal scale as follows: 0 = normal, 1 = superficial bleeding after scraping, 2 = superficial bleeding with light touching and 3 = presence of petechiae bleeding with light touching
Measured: 14 days
Rate of mucosa pallor
Change from baseline to 14 days assessed by the Investigator during the medical examination and scored by a ordinal scale as follows: 0 = no pallor, 1 = slight pallor, 2 = moderate pallor, and 3 = pallor of severe intensity
Measured: 14 days
Quantity of vaginal discharge assessment
Change from baseline to 14 days assessed by the Investigator during the medical examination and scored by a ordinal scale as follows: 0 =normal discharge overall vaginal walls, 1 = discharge covering of the vaginal walls, 2 = Scanty discharge that do not cover the entire vaginal walls, and 3 = no vaginal discharge
Measured: 14 days
Whiff test
Change from baseline to 14 days evaluated by the following procedure: after medical examination, a sample of the vaginal discharge is placed on a glass slide, and a drop of 10% potassium hydroxide (10%KOH) is added to evaluate the presence of a fishy odour caused by the release of amine. A positive Whiff test occurs when an unpleasant odour is detected after applying the KOH solution, indicating the presence of amines. A negative Whiff test suggests the absence of this characteristic odour.
Measured: 14 days
Rate of Lactobacillus grade according to Ison Hay's classification by bacterioscopic smear
Change from baseline to 14 days of the grade according to the modified Ison-Hay scoring system: grade 0, epithelial cells with no bacteria; grade 1, normal vaginal flora (lactobacillus morphotypes alone); grade II, reduced numbers of lactobacillus morphotypes with mixed bacterial flora; grade III, mixed bacterial flora only, few or absent lactobacillus morphotypes; grade IV, Gram-positive cocci only.
Measured: 14 days
Microbiological evaluation by culture examination of the vaginal swab
Change from baseline to 14 days evaluated by the following procedure: the Investigator takes samples of mucus and cells from the endocervix by a swab. The samples are placed in a culture dish for a processing time of 48-72 hours to identify the presence of specific microorganisms.
Measured: 14 days
Molecular sequencing-based microbiological analysis of vaginal microbiota by next-generation sequencing (NGS) method.
The following procedure evaluates change from baseline to 14 days: the swab is rotated in the vagina and transferred immediately on dry ice; after the sample is collected and preserved in a Copan FLOQ Sampling tube (Copan Diagnostics, Murrieta, CA, USA) at - 80 °C; the extracted DNAs are stored at - 80 °C; the sequencing is performed through the Shotgun sequencing approach. The libraries are prepared using the Illumina DNA Prep kit. The sequencing is conducted through the Illumina Novaseq 6000 system based on 2 x 150 bp paired-end reads.
the raw reads across the samples sequences are used as input for the data analysis and finally to compare the microbiota of studied patients' groups.
Measured: 14 days
Serious Adverse Device Effects / Serious Adverse Events /Adverse Device Effects/ Adverse Events
The number of participants with treatment-related adverse events will be assessed by CTCAE v6.0
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start30 Jun 2023 (estimated)
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pre- Peri, and Postmenopausal 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gemelli Molise Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Responsible party
- Sponsor
- Investigators
- Francesco Cosentino, PhD, Principal investigator, U.O.C. Ginecologia Oncologica Gemelli MoliseRoberto Di Marco, PhD, Principal investigator, Microbiologia e Microbiologia Clinica Dipartimento Medicina e Scienze per la salute "V. Tiberio" Università degli Studi del Molise Campobasso (Italy) Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918848
- Sponsor's protocol ID
- GEMMOL GYNE 01/2023
- Status last verified
- Jun 2023
- First submitted
- 11 May 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Costantino D, Guaraldi C. Effectiveness and safety of vaginal suppositories for the treatment of the vaginal atrophy in postmenopausal women: an open, non-controlled clinical trial. Eur Rev Med Pharmacol Sci. 2008 Nov-Dec;12(6):411-6.
PubMed 19146203Palma F, Volpe A, Villa P, Cagnacci A; Writing group of AGATA study. Vaginal atrophy of women in postmenopause. Results from a multicentric observational study: The AGATA study. Maturitas. 2016 Jan;83:40-4. doi: 10.1016/j.maturitas.2015.09.001. Epub 2015 Sep 14.
PubMed 26421474Dimery IW, Hong WK, Lee JJ, Guillory-Perez C, Pham F, Fritsche HA Jr, Lippman SM. Phase I trial of alpha-tocopherol effects on 13-cis-retinoic acid toxicity. Ann Oncol. 1997 Jan;8(1):85-9. doi: 10.1023/a:1008209525671.
PubMed 9093712Panin G, Strumia R, Ursini F. Topical alpha-tocopherol acetate in the bulk phase: eight years of experience in skin treatment. Ann N Y Acad Sci. 2004 Dec;1031:443-7. doi: 10.1196/annals.1331.069.
PubMed 15753192Burton GW, Ingold KU. Vitamin E as an in vitro and in vivo antioxidant. Ann N Y Acad Sci. 1989;570:7-22. doi: 10.1111/j.1749-6632.1989.tb14904.x.
PubMed 2698111
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance and Safety of Vaginal Administration of Tocopherol Acetate (Vitamin E) in Pre- Peri and Postmenopausal Women
- ClinicalTrials.gov ID
- NCT05918848
- Acronym / sponsor ID
- GEMMOL GYNE 01/2023
- Conditions
- Pre- Peri, and Postmenopausal Women
- Keywords
- Premenopause, perimenopause, postmenopause, vaginal eubiosis, lactobacilli flora, microbiota
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Gemelli Molise HospitalUniversity, hospital or other
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Study start
- 30 Jun 2023 (estimated)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 26 Jun 2023 (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.
The purpose of this non-controlled Investigator Initiated Trail (IIT), with a retrospective design is to evaluate the performance and safety of the vaginal administration of tocopherol acetate (vitamin E) in pre-peri and postmenopausal women. The main objectives of the study will be the evaluation of the vaginal pH, of the vaginal eubiosis improving the lactobacilli flora and microbiota, and of sign and symptoms of women. The patients were visited at baseline (with the collection of vaginal swabs) and treated with vaginal administration of tocopherol acetate for 14 days. At the end of treatment (final visit) the patients were visited with the collection of vaginal swabs.
Detailed description
The vaginal microbiota has a significant bearing on a woman's mental and physical health at every stage of life. A balanced microflora of the vaginal environment (eubiosis) consists of a predominant presence of lactic acid bacteria. Lactobacilli ensure the maintenance of an acidic pH that effectively makes the environment inhospitable to pathogens by preventing infection and protecting the genital tract. At the end of the reproductive period, the reduction of sex hormones, particularly estrogen, results in a decrease in the lactobacillus component with consequent depletion of the vaginal microbiota and increased susceptibility to pathogens. Tocopherol (vitamin E) is an essential human nutrient found mainly in oily fruits. It is a fat-soluble molecule with high antioxidant power. Topically administered, it not only plays a key role in protecting epithelial cell membranes from oxidative damage but is also able to modulate bacterial growth by contributing to pH acidification. The latter feature, in the vaginal canal, creates a favorable environment for the lactobacilli flora, positively affecting the microbial population and thus contributing to the prevention of all those problems related to increased vaginal sensitivity to pathogens during "menopause." In addition, recent data show that vitamin E can counteract the production of biofilm produced by certain pathogens, which has detrimental effects on the homeostasis of the vaginal environment.
The period of observation is from January 1st, 2020 to December, 31st, 2022, while the Data Collection period will be from June, 30th, 2023 to July, 31st, 2023
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients admitted in the Center for gynecologic visits in the period from January 1st, 2020 to December, 31st, 2022 and found eligible for inclusion in the study.
Key inclusion criteria (3 listed)
- Women aged ≥ 50 to ≤ 70 years included.
- Premenopause, perimenopause,postmenopause women (according to STRAW criteria)
- Patients able to comply with the requirements for the study and freely willing to provide written informed consent to the retrospectively collection of their data.
Key exclusion criteria (10 listed)
- Malignancy (also leukemic infiltrates) within 5 years prior to day 0 (except for treated basal cell/squamous cell carcinoma of the skin).
- Genital bleeding.
- Oestrogen topical (vaginal) treatment during the study period (it must have been terminated at least 6 months before the beginning of the study).
- Systemic oestrogen therapy during the study period (it must have been terminated at least 6 months before the beginning of the study).
- Patients with any illness, or any other medical condition, that, in the opinion of the Investigator, would compromise the participation or be likely to lead to hospitalisation during the study.
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 |
|---|---|---|
| Filme Gyno-V® Vaginal OvulesAdministration of tocopherol (Filme Gyno-V® Vaginal Ovules) for 14 days | Device | – |
Primary outcome
Acidity measure of vaginal secretions
Time frame: 14 days
It is assessed by Investigator during the medical examination using a pH strip (Merck, Darmstadt, Germany) with a range of 4.0 (acidic) to 7.0 (alkaline). The strip is placed on the lateral walls of the vagina to avoid contact with alkaline cervical secretions. The Investigator dip the pH test strip in the vaginal secretion for two seconds. The more acidic the vaginal secretion, the more red the strip turns, and the more alkaline the vaginal secretion, the more blue the strip turns. This provides a semiquantitative measure of pH by visually comparing the four reaction zones on the test strip to the areas of the colour scale. pH measurement serves as an indicator of the vaginal environment and the balance of microorganisms present.
9 secondary outcomes
Rate of vaginal mucosa dryness
Time frame: 14 days
Rate of vaginal mucosal integrity
Time frame: 14 days
Rate of mucosa pallor
Time frame: 14 days
Quantity of vaginal discharge assessment
Time frame: 14 days
Whiff test
Time frame: 14 days
Rate of Lactobacillus grade according to Ison Hay's classification by bacterioscopic smear
Time frame: 14 days
Microbiological evaluation by culture examination of the vaginal swab
Time frame: 14 days
Molecular sequencing-based microbiological analysis of vaginal microbiota by next-generation sequencing (NGS) method.
Time frame: 14 days
Serious Adverse Device Effects / Serious Adverse Events /Adverse Device Effects/ Adverse Events
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Background: PubMed 19146203Costantino D, Guaraldi C. Effectiveness and safety of vaginal suppositories for the treatment of the vaginal atrophy in postmenopausal women: an open, non-controlled clinical trial. Eur Rev Med Pharmacol Sci. 2008 Nov-Dec;12(6):411-6.
- Background: PubMed 26421474Palma F, Volpe A, Villa P, Cagnacci A; Writing group of AGATA study. Vaginal atrophy of women in postmenopause. Results from a multicentric observational study: The AGATA study. Maturitas. 2016 Jan;83:40-4. doi: 10.1016/j.maturitas.2015.09.001. Epub 2015 Sep 14.
- Background: PubMed 9093712Dimery IW, Hong WK, Lee JJ, Guillory-Perez C, Pham F, Fritsche HA Jr, Lippman SM. Phase I trial of alpha-tocopherol effects on 13-cis-retinoic acid toxicity. Ann Oncol. 1997 Jan;8(1):85-9. doi: 10.1023/a:1008209525671.
- Background: PubMed 15753192Panin G, Strumia R, Ursini F. Topical alpha-tocopherol acetate in the bulk phase: eight years of experience in skin treatment. Ann N Y Acad Sci. 2004 Dec;1031:443-7. doi: 10.1196/annals.1331.069.
- Background: PubMed 2698111Burton GW, Ingold KU. Vitamin E as an in vitro and in vivo antioxidant. Ann N Y Acad Sci. 1989;570:7-22. doi: 10.1111/j.1749-6632.1989.tb14904.x.
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.
Francesco Cosentino, PhD principal investigator
U.O.C. Ginecologia Oncologica Gemelli Molise
Roberto Di Marco, PhD principal investigator
Microbiologia e Microbiologia Clinica Dipartimento Medicina e Scienze per la salute "V. Tiberio" Università degli Studi del Molise Campobasso (Italy) Laboratory
Questions about this trial
What is this clinical trial studying?
An observational study of Pre- Peri, and Postmenopausal Women, run by Gemelli Molise Hospital.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Cosentino (0874312549, francesco.cosentino@unimol.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acidity measure of vaginal secretions (time frame: 14 days). 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 NCT05918848, which also lists 5 linked publications.
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 26 Jun 2023.