Tocopherol Acetate Vaginal Administration in Pre-peri and Postmenopausal Women

NCT05918848 | Unknown DMC

• 1 other identifier: GEMMOL GYNE 01/2023
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Pre- Peri, and Postmenopausal Women

Keywords

Premenopause; perimenopause; postmenopause; vaginal eubiosis; lactobacilli flora; microbiota

Outcome Measures

Primary Outcomes (1)

• 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.

  14 days

Secondary Outcomes (9)

• Rate of vaginal mucosa dryness

  14 days

• Rate of vaginal mucosal integrity

  14 days

• Rate of mucosa pallor

  14 days

• Quantity of vaginal discharge assessment

  14 days

• Whiff test

  14 days

Interventions

Filme Gyno-V® Vaginal Ovules DEVICE

Administration of tocopherol (Filme Gyno-V® Vaginal Ovules) for 14 days

Eligibility Criteria

• Age: 50 Years - 70 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Gemelli Molise Hospital: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Related Publications (5)

• 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.

  PMID: 19146203 BACKGROUND

• Palma 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.

  PMID: 26421474 BACKGROUND

• Dimery 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.

  PMID: 9093712 BACKGROUND

• Panin 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.

  PMID: 15753192 BACKGROUND

• Burton 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.

  PMID: 2698111 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

vaginal swabs for 24 women. molecular microbiological examination for evaluation of the microbiota. The swabs were stored at -80°C to be subjected to molecular analysis

Study Officials

• Francesco Cosentino, PhD

  U.O.C. Ginecologia Oncologica Gemelli Molise

  PRINCIPAL INVESTIGATOR

• Roberto Di Marco, PhD

  Microbiologia e Microbiologia Clinica Dipartimento Medicina e Scienze per la salute "V. Tiberio" Università degli Studi del Molise Campobasso (Italy) Laboratory

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Cosentino

CONTACT

0874312549; francesco.cosentino@unimol.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: June 26, 2023
• Study Start: June 30, 2023
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: June 26, 2023

Record last verified: 2023-06