Vaginal dryness in menopause, pain during intercourse and pH alteration: the scientific and clinical rationale behind Revaginal Ovules
Vaginal dryness does not appear suddenly. It gradually develops, often during perimenopause, when menstrual cycles begin to become irregular and hormonal balance loses stability.
At first, it is a mild sensation of tension or burning. Then it becomes pain during intercourse, persistent irritation, and sometimes recurrent infections. For many women it is a silent disorder, rarely reported, yet with a real impact on quality of life.
From an epidemiological perspective, the phenomenon is far from marginal. The large longitudinal SWAN study (Study of Women’s Health Across the Nation), which followed over 2,400 women for a period of 17 years, highlights how the prevalence of vaginal dryness increases significantly: from 19.4% in the early stages of the menopausal transition to 34% in the postmenopausal period.
Launched in 1996 in the United States, the SWAN Study was designed to analyze the biological, psychological and social changes accompanying the transition to menopause. By involving women of different ethnicities, it has provided key data on symptom trends, hormonal variations and the impact on cardiovascular, bone and mental health during the climacteric period.
The increase in vaginal dryness is particularly marked near the final menstrual period, confirming the central role of endocrine transition in the onset and intensification of the disorder.
Vaginal dryness and estrogen decline
The most robust finding emerging from the analysis is the close association between menopausal stage and symptom onset.
As menopause progresses, the risk of developing vaginal dryness increases. Higher levels of endogenous estradiol are protective, whereas androgens such as testosterone and DHEAS show no significant correlations.
Biologically, the explanation is consistent: the reduction in estrogen leads to thinning of the vaginal epithelium, decreased secretion, reduced vascularization and alteration of the microbiota. The pH tends to increase, lactobacilli decrease and the mucosa becomes more vulnerable to microtrauma and inflammation.
Dryness is therefore not merely a “lack of lubrication,” but the result of a structural transformation of the vaginal microenvironment.
From discomfort to dyspareunia
The SWAN study also documents a significant association between vaginal dryness and the onset of pain during intercourse.
The relationship is bidirectional: dryness may precede dyspareunia, but pain can also worsen the reduction in lubrication, creating a cycle of avoidance and discomfort.
When the mucosa is dehydrated and the pH altered, the protective barrier loses effectiveness. Tissue resilience decreases, sensitivity increases and the risk of inflammation rises. In this scenario, targeted intervention can make a difference, provided it does not merely offer immediate relief but acts on the underlying physiological mechanisms.
Revaginal Ovules: acting on the microenvironment
Revaginal Ovules is a class IIa medical device formulated to address vaginal dryness in an integrated manner.
The objective is not only to lubricate, but to restore conditions favorable to mucosal physiology.
The presence of hyaluronic acid allows intense and prolonged hydration due to its ability to bind water. Polycarbophil, a mucoadhesive polymer, prolongs the residence time of the product on the mucosa, promoting gradual release and continuous action.
Lactic acid contributes to restoring physiological pH (approximately 3.5), a crucial element in supporting lactobacillary flora.
Completing the formulation, vitamin E and 18-beta-glycyrrhetinic acid support cellular integrity, while triglycerides improve glide and local comfort.
The combined action results in increased hydration and lubrication, reduction of burning and support for the rebalancing of the vaginal microenvironment.
Clinical evaluation and symptomatic outcomes
The efficacy of the formulation was observed in a prospective monitoring study on women with symptoms of dryness, irritation and pain, assessed using the VSQ questionnaire. The protocol included the application of one ovule per day for 10 consecutive days.
The VSQ (Vaginal Symptom Questionnaire) is a validated questionnaire used to assess the presence and impact of vaginal symptoms such as dryness, burning or pain during intercourse. It is a clinical tool useful for measuring the severity of disorders and their effect on quality of life, especially in peri- and postmenopause.
At the end of treatment, score analysis showed a reduction in dryness of up to 90%, complete resolution of burning and itching in the observed cases, and a significant decrease in pain. An improvement in perceived intimate well-being was also recorded.
These results are consistent with the pathophysiological rationale: when hydration is restored and pH normalized, the mucosa progressively recovers its trophic and protective function.
A strategic opportunity in the gynecological segment
An often overlooked aspect is that more than half of women with vaginal dryness do not discuss it with their doctor.
The need exists but remains largely unmet. This makes the non-hormonal medical device segment particularly dynamic.
Revaginal Ovules represents a market-ready solution, available in private label or ready for commercialization.
In a context where demand for safe, non-hormonal and evidence-based solutions is growing, having a formulation platform supported by longitudinal and clinical data means offering much more than a product: it means providing a response consistent with female physiology.
We are manufacturers of medical devices, food supplements and cosmetics ready for commercialization: choose private label or CDMO service and develop your next product with us.
Source: “Factors associated with developing vaginal dryness symptoms in women transitioning through menopause: a longitudinal study, Menopause (NIH)” PubMed, doi: 10.1097/GME.0000000000001130
