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Vulvovaginal AtrophyPhase 2NCT04487392

Photobiomodulation Effect on Vulvovaginal Atrophy in Postmenopausal Women.

A Phase 2 study testing Estrogen vaginal cream group (group A) and Photobiomodutation group (group B) in people with Vulvovaginal Atrophy, run by University of Nove de Julho.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Vulvovaginal Atrophy
What is being tested?
Estrogen vaginal cream group (group A) and Photobiomodutation group (group B)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
15 Dec 2020to 30 Dec 2021
Phase
Phase 2
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

About this study

Official title: Photobiomodulation Effect on Vulvovaginal Atrophy in Postmenopausal Women: Randomized and Controlled Trial.

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.

Being tested
Estrogen vaginal cream group (group A), Photobiomodutation group (group B)
Keywords
genitourinary syndrome, LED, light emitting diode, vulvovaginal atrophy, menopause, climacteric, photobiomodulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Estrogen vaginal cream group (group A)Drug

    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.

  • Photobiomodutation group (group B)Radiation

    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.

Study groups in NCT04487392
Study groupRoleWhat they receive
Estrogen vaginal cream group (group A)Active comparator22 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.
Receives: Drug: Estrogen vaginal cream group (group A)
Photobiomodutation group (group B)Experimental22 participants will be included in this group. The participants selected for group B will be undergo photobiomodulation with red LED.
Receives: Radiation: Photobiomodutation group (group B)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 6 months

Secondary outcomes (3)

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 6 months

  3. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2020
  2. Study start15 Dec 2020 (estimated)
  3. Primary completion30 Sep 2021 (estimated)
  4. Study completion30 Dec 2021 (estimated)

Why it stopped: The student do not start the study

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04487392
Sponsor's protocol ID
LEDATROPHY
Status last verified
Jul 2020
First submitted
24 Jul 2020
Last updated
29 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 27188659

  • 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.

    PubMed 24771324

  • Takahashi TA, Johnson KM. Menopause. Med Clin North Am. 2015 May;99(3):521-34. doi: 10.1016/j.mcna.2015.01.006.

    PubMed 25841598

  • 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.

    PubMed 27472999

  • 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.

    PubMed 23679050

  • 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.

    PubMed 19936472

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Estrogen vaginal cream group (group A) and Photobiomodutation group (group B) in people with Vulvovaginal Atrophy, run by University of Nove de Julho.

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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 29 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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?

Objective assessment of improvement in vulvovaginal atrophy symptoms. (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT04487392, which also lists 6 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 29 Jun 2023.

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