Photobiomodulation Effect on Vulvovaginal Atrophy in Postmenopausal Women.
Primary Purpose
Vulvovaginal Atrophy
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Estrogen vaginal cream group (group A)
Photobiomodutation group (group B)
Sponsored by
About this trial
This is an interventional treatment trial for Vulvovaginal Atrophy focused on measuring genitourinary syndrome, LED, light emitting diode, vulvovaginal atrophy, menopause, climacteric, photobiomodulation
Eligibility Criteria
Inclusion Criteria:
- postmenopausal women (amenorrhea for less than 12 months);
- presence one or more symptoms of vulvovaginal atrophy (dyspareunia, dryness, irritation and vaginal burning);
- Vaginal Heath Index ≤ 15 (signs of atrophy);
- normal cytopathology of uterine cervix in the last year.
Exclusion Criteria:
- previous or current history of gynecological neoplasia;
- who used hormonal or non-hormonal treatment for vulvovaginal symptoms of menopause;
- current or recent genitourinary lesions or infectious processes in the genitourinary tract (last month);
- current or recent (last month) systemic treatment with antifungals, antibiotics or corticosteroids;
- presence of genital prolapse;
- presence of contraindications to the use of vaginal estrogen (current, previous or suspected diagnosis of breast cancer, malignant estrogen-dependent tumors, uninvestigated uterine bleeding, untreated endometrial hyperplasia, deep venous thrombosis and current or previous pulmonary thromboembolism, known thrombophilia, recent or active arterial disease, acute liver disease, porphyria, use of drugs that may interact with estriol and hypersensitivity to the components of the vaginal cream formula).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Estrogen vaginal cream group (group A)
Photobiomodutation group (group B)
Arm Description
22 participants will be included in this group. The participants selected for group A will be provided with estriol 0.01% vaginal cream, which should be applied at home.
22 participants will be included in this group. The participants selected for group B will be undergo photobiomodulation with red LED.
Outcomes
Primary Outcome Measures
Objective assessment of improvement in vulvovaginal atrophy symptoms.
Vaginal Health Index: an objective assessment will be performed using the parameters of the Vaginal Health Index, in which elasticity, fluid volume, pH, epithelial integrity and moisture are evaluated. Each aspect evaluated receives a score, which varies from 1 to 5. The score can vary from 5 to 25, being considered a diagnosis of vulvovaginal atrophy when the values are less than or equal to 15. This evaluation will be performed by a qualified gynecologist during the exam physicist.
Subjetive assessment of improvement in vulvovaginal atrophy symptoms.
Visual Analog scale: the assessment of vulvovaginal atrophy symptoms will be made using the visual analog scale. The patient will receive a ruler with markings from 0 to 10, one end of which indicates complete absence of symptoms and the other indicates the worst possible symptom. This assessment will be applied to each of the symptoms: dyspareunia, dryness, irritation.
Secondary Outcome Measures
Vaginal pH
The evaluation of the vaginal pH will be performed through the pH indicator strip, which when inserted in the middle third of the vagina in contact with the mucosa, has the color of the strip changed.
Female Sexual Function Index
The quality of the participants' sexual activity will be assessed through the questionnaire validated for the Portuguese "Female Sexual Function Index". This questionnaire is a brief and self-applied instrument that assesses the female sexual response in the last four weeks in relation to sexual desire, vaginal lubrication, orgasm, sexual satisfaction and pain.
Vaginal Cell Maturation Index
Also known as Frost Index, whose aim is to assess the hormonal influence in women by counting the epithelial cells of the vagina. The frequencies of parabasal, intermediate and superficial cells are evaluated. For this, a scraping of the lateral wall of the vagina is performed with a spatula, in order to obtain vaginal cells for cytology. The cells will be fixed on a slide and later colored with HE (Hematoxylin-Eosin) for analysis and counting.
Full Information
NCT ID
NCT04487392
First Posted
July 24, 2020
Last Updated
June 27, 2023
Sponsor
University of Nove de Julho
1. Study Identification
Unique Protocol Identification Number
NCT04487392
Brief Title
Photobiomodulation Effect on Vulvovaginal Atrophy in Postmenopausal Women.
Official Title
Photobiomodulation Effect on Vulvovaginal Atrophy in Postmenopausal Women: Randomized and Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Why Stopped
The student do not start the study
Study Start Date
December 15, 2020 (Anticipated)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Menopause is a physiological event and is defined as the loss of ovarian follicular activity, with consequent permanent cessation of menstrual cycles. Its diagnosis is made retrospectively after 12 months of amenorrhea, with no pathological cause involved. This period is marked by several changes in the female organism, mainly the genitourinary syndrome (GUS), which is a collection of signs and symptoms resulting from the state of hypoestrogenism. Almost half of postmenopausal women will experience symptoms of GUS, with vaginal dryness being the most prevalent, followed by dyspareunia and vulvovaginal irritation. The aim of the study is to evaluate the effect of photobiomodulation with red LED (ligth emitting diode) on the symptoms of vulvovaginal atrophy in postmenopausal women. A randomized and controlled clinical trial will be developed, which will include postmenopausal women with signs and symptoms of vulvovaginal atrophy. Participants will be allocated into two groups: those who will undergo photobiomodulation with intravaginal LED, and those who will receive vaginal cream with estriol. Objective and subjective improvement of atrophy will be assessed using the Vaginal Health Index and the visual analog scale, respectively. Vaginal pH, cell maturation index and changes in sexual function through the Female Sexual Function Index questionnaire will also be assessed. The variables will be analyzed at the time of admission, in one and three months after the intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Atrophy
Keywords
genitourinary syndrome, LED, light emitting diode, vulvovaginal atrophy, menopause, climacteric, photobiomodulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Estrogen vaginal cream group (group A)
Arm Type
Active Comparator
Arm Description
22 participants will be included in this group. The participants selected for group A will be provided with estriol 0.01% vaginal cream, which should be applied at home.
Arm Title
Photobiomodutation group (group B)
Arm Type
Experimental
Arm Description
22 participants will be included in this group. The participants selected for group B will be undergo photobiomodulation with red LED.
Intervention Type
Drug
Intervention Name(s)
Estrogen vaginal cream group (group A)
Intervention Description
The participants selected for group A will be provided with estriol 0.01% vaginal cream, which should be applied at home: 1 intravaginal applicator at night, daily for 2 weeks, followed by 2 times a week, on alternate days (Monday - Thursday) for another 2 weeks.
Intervention Type
Radiation
Intervention Name(s)
Photobiomodutation group (group B)
Intervention Description
The participants selected for group B will be undergo photobiomodulation with red LED. With the participant in the lithotomy position, the speculum will be introduced into the vaginal canal and a vaginal wash with 0.9% saline will be performed to remove secretions. Afterwards, the speculum will be removed and the device with a red LED inserted up to about 6 cm from the introitus. A non-lubricated condom will be used in the LED device for patient protection. Sessions will take place once a week for 4 weeks.
Primary Outcome Measure Information:
Title
Objective assessment of improvement in vulvovaginal atrophy symptoms.
Description
Vaginal Health Index: an objective assessment will be performed using the parameters of the Vaginal Health Index, in which elasticity, fluid volume, pH, epithelial integrity and moisture are evaluated. Each aspect evaluated receives a score, which varies from 1 to 5. The score can vary from 5 to 25, being considered a diagnosis of vulvovaginal atrophy when the values are less than or equal to 15. This evaluation will be performed by a qualified gynecologist during the exam physicist.
Time Frame
6 months
Title
Subjetive assessment of improvement in vulvovaginal atrophy symptoms.
Description
Visual Analog scale: the assessment of vulvovaginal atrophy symptoms will be made using the visual analog scale. The patient will receive a ruler with markings from 0 to 10, one end of which indicates complete absence of symptoms and the other indicates the worst possible symptom. This assessment will be applied to each of the symptoms: dyspareunia, dryness, irritation.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Vaginal pH
Description
The evaluation of the vaginal pH will be performed through the pH indicator strip, which when inserted in the middle third of the vagina in contact with the mucosa, has the color of the strip changed.
Time Frame
6 months
Title
Female Sexual Function Index
Description
The quality of the participants' sexual activity will be assessed through the questionnaire validated for the Portuguese "Female Sexual Function Index". This questionnaire is a brief and self-applied instrument that assesses the female sexual response in the last four weeks in relation to sexual desire, vaginal lubrication, orgasm, sexual satisfaction and pain.
Time Frame
6 months
Title
Vaginal Cell Maturation Index
Description
Also known as Frost Index, whose aim is to assess the hormonal influence in women by counting the epithelial cells of the vagina. The frequencies of parabasal, intermediate and superficial cells are evaluated. For this, a scraping of the lateral wall of the vagina is performed with a spatula, in order to obtain vaginal cells for cytology. The cells will be fixed on a slide and later colored with HE (Hematoxylin-Eosin) for analysis and counting.
Time Frame
6 months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
postmenopausal women (amenorrhea for less than 12 months);
presence one or more symptoms of vulvovaginal atrophy (dyspareunia, dryness, irritation and vaginal burning);
Vaginal Heath Index ≤ 15 (signs of atrophy);
normal cytopathology of uterine cervix in the last year.
Exclusion Criteria:
previous or current history of gynecological neoplasia;
who used hormonal or non-hormonal treatment for vulvovaginal symptoms of menopause;
current or recent genitourinary lesions or infectious processes in the genitourinary tract (last month);
current or recent (last month) systemic treatment with antifungals, antibiotics or corticosteroids;
presence of genital prolapse;
presence of contraindications to the use of vaginal estrogen (current, previous or suspected diagnosis of breast cancer, malignant estrogen-dependent tumors, uninvestigated uterine bleeding, untreated endometrial hyperplasia, deep venous thrombosis and current or previous pulmonary thromboembolism, known thrombophilia, recent or active arterial disease, acute liver disease, porphyria, use of drugs that may interact with estriol and hypersensitivity to the components of the vaginal cream formula).
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27188659
Citation
Davis SR, Lambrinoudaki I, Lumsden M, Mishra GD, Pal L, Rees M, Santoro N, Simoncini T. Menopause. Nat Rev Dis Primers. 2015 Apr 23;1:15004. doi: 10.1038/nrdp.2015.4.
Results Reference
background
PubMed Identifier
24771324
Citation
Schoenaker DA, Jackson CA, Rowlands JV, Mishra GD. Socioeconomic position, lifestyle factors and age at natural menopause: a systematic review and meta-analyses of studies across six continents. Int J Epidemiol. 2014 Oct;43(5):1542-62. doi: 10.1093/ije/dyu094. Epub 2014 Apr 26.
Results Reference
background
PubMed Identifier
25841598
Citation
Takahashi TA, Johnson KM. Menopause. Med Clin North Am. 2015 May;99(3):521-34. doi: 10.1016/j.mcna.2015.01.006.
Results Reference
background
PubMed Identifier
27472999
Citation
Gandhi J, Chen A, Dagur G, Suh Y, Smith N, Cali B, Khan SA. Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management. Am J Obstet Gynecol. 2016 Dec;215(6):704-711. doi: 10.1016/j.ajog.2016.07.045. Epub 2016 Jul 26.
Results Reference
background
PubMed Identifier
23679050
Citation
Kingsberg SA, Wysocki S, Magnus L, Krychman ML. Vulvar and vaginal atrophy in postmenopausal women: findings from the REVIVE (REal Women's VIews of Treatment Options for Menopausal Vaginal ChangEs) survey. J Sex Med. 2013 Jul;10(7):1790-9. doi: 10.1111/jsm.12190. Epub 2013 May 16.
Results Reference
background
PubMed Identifier
19936472
Citation
Pacagnella Rde C, Martinez EZ, Vieira EM. [Construct validity of a Portuguese version of the Female Sexual Function Index]. Cad Saude Publica. 2009 Nov;25(11):2333-44. doi: 10.1590/s0102-311x2009001100004. Portuguese.
Results Reference
background
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Photobiomodulation Effect on Vulvovaginal Atrophy in Postmenopausal Women.
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