Clinical Research & Resources

Since 2003 our partners at Good Clean Love have worked with leading scientists and doctors to develop products that support sexual health and feminine hygiene – with low osmolality and mimicking a healthy vaginal pH – without harmful petrochemicals, parabens and synthetic fragrances. These scientifically-advanced products are being recommended by thousands of medical providers nationwide, for patients of all ages and at all stages of life, to improve their vaginal health and enhance their intimate relationships.

UN Global Consultation On Personal Lubricants

Non-toxic Lubricants For Vaginal And Rectal Intercourse: Anatomy And Physiology

Reviews evidence of epithelial damage and resulting instances of BV resulting from the use of higher osmolality personal lubricants during intercourse. (2016)

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Johns Hopkins University

Studies Raise Questions About Safety Of Personal Lubricants


Reports that isosmolar lubricants, such as agar-based Good Clean Love, did not damage cervical tissue samples or boost sexually transmitted infection rates. (2012)

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Backed By Clinical Studies: Promoting Conditions That Match Optimal Vaginal pH

Patented Bio Match™ products are formulated to provide women with healthier options for combating a variety of conditions and symptoms. Restore Moisturizing Vaginal Gel and BiopHresh Vaginal Probiotic Supplement support the growth of good lactobacilli. BioNude Ultra Sensitive Personal Lubricant is iso-osmotic; a characteristic shown to reduce epithelial damage during intercourse. Balance Moisturizing Personal Wash and Rebalance Feminine Wipes clean and are balanced to optimal pH levels. Try them in your clinic. Provide samples to your patients. They’ll thank you!

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Interactions Between Inflammation and Female Sexual Desire and Arousal Function
Tierney K. Lorenz. Current Sexual Health Controls (2019) 



Purpose of Review
To describe the current state of research on interactions between inflammation and female sexual function.
Recent Findings
Inflammation may interfere with female sexual desire and arousal via direct (neural) and indirect (endocrine, vascular, social/behavioral) pathways. There are significant sex differences in the effect of inflammation on sexual function, arising from different evolutionary selection pressures on the regulation of reproduction. A variety of inflammation-related conditions are associated with the risk of female sexual dysfunction, including cardiovascular disease, metabolic syndrome, and chronic pain.
Summary
Clinical implications include the need for routine assessment for sexual dysfunction in patients with inflammation-related conditions, the potential for anti-inflammatory diets to improve sexual desire and arousal function, and consideration of chronic inflammation as moderator of sexual effects of hormonal treatments. Although the evidence points to a role for inflammation in the development and maintenance of female sexual dysfunction, the precise nature of these associations remains unclear.


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Characterization of a Bacteriocin-Like Substance Produced by a Vaginal Lactobacillus salivarius Strain
Virginia S. Ocaña, Aída A. Pesce de Ruiz Holgado, and María Elena Nader-Macías. Applied and Environmental Microbiology (1999)

 

A novel bacteriocin-like substance produced by vaginal Lactobacillus salivarius subsp. salivarius CRL 1328 with activity against Enterococcus faecalis, Enterococcus faecium, and Neisseria gonorrhoeae was characterized. The highest level of production of this heat-resistant peptide or protein occurred during the late exponential phase. Its mode of action was shown to be bactericidal. L. salivarius subsp. salivarius CRL 1328 could be used for the design of a probiotic to prevent urogenital infections.

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Is Wetter Better? An Evaluation of Over-the-Counter Personal Lubricants for Safety and Anti-HIV-1 Activity
Charlene S. Dezzutti, Elizabeth R. Brown, Bernard Moncla, et al. International DOI Foundation (2012)

 

Because lubricants may decrease trauma during coitus, it is hypothesized that they could aid in the prevention of HIV acquisition. Therefore, safety and anti-HIV-1 activity of over-the-counter (OTC) aqueous- (n = 10), lipid- (n = 2), and silicone-based (n = 2) products were tested. None of the lubricants that had a moderate to high therapeutic index protected the mucosal tissue. These results show hyperosmolar lubricant gels were associated with cellular toxicity and epithelial damage while showing no anti-viral activity. The two iso-osmolar lubricants, Good Clean Love and PRÉ, and both silicone-based lubricants, Female Condom 2 lubricant and Wet Platinum, were the safest in our testing algorithm.

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Characterization of Commercially Available Vaginal Lubricants: A Safety Perspective
Ana Raquel Cunha, Rita M. Machado, Ana Palmeira-de-Oliveira, et al. (2012)

 

Twelve commercially available gel products were tested for pH value, pH buffering capacity, osmolality and cytotoxicity relevant to vaginal delivery. Obtained data were analyzed in light of the recent Advisory Note by the World Health Organization (WHO) for personal lubricants to be concomitantly used with condoms. Results showed that most products do not comply with pH and osmolality recommended standards, thus posing a potential hazard. Four products presented values of osmolality around three-times higher than the maximum acceptable limit of 1200 mOsm/kg. In vitro cell testing further identified substantial cytotoxicity even at 1:100 dilutions for three products, contrasting with no significant effect of up to at least a 1:5 dilution of a Universal Placebo gel. However, no direct correlation between these last results and pH or osmolality was found, thus suggesting that the individual toxicity of specific formulation components plays an important role in the outcome of a particular product.

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Women's Perceptions About Lubricant Use and Vaginal Wetness During Sexual Activities
Kristen N. Jozkowski PhD, Debby Herbenick PhD, MPH, Vanessa Schick PhD, et al. International Society For Sexual Medicine (2012)

 

Exogenous lubricant use in the United States is common among women; however, there is little empirical research describing women's perceptions of lubricants, lubricant use, and vaginal wetness or dryness during penile‐vaginal intercourse or other sexual behaviors. Findings suggest that women generally feel positively about lubricants and lubricant use and prefer vaginal‐penile intercourse to feel more wet. Such insights into women's perceptions of lubricants and lubricant use can be helpful to medical and other health professionals as well as sexual health educators, who routinely make recommendations to women about ways to incorporate products, such as lubricants, into their sexual activities.

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Effects of Feminine Hygiene Products on the Vaginal Mucosal Biome
Bisiayo Fashemi, Mary L. Delaney M.A., Andrew B. Onderdonk Ph.D. & Raina N. Fichorova M.D., Ph.D. Microbial Ecology in Health and Disease (2013)

 

This study evaluates in-vitro their effects on Lactobacillus crispatus, which is dominant in the normal vaginal microbiota and helps maintain a healthy mucosal barrier essential for normal reproductive function and prevention of sexually transmitted infections and gynecologic cancer. Some OTC vaginal products may be harmful to L. crispatus and alter the vaginal immune environment. Illustrated through these results, L. crispatus is essential in the preservation of the function of vaginal epithelial cells in the presence of some feminine hygiene products.

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Hyperosmolar Sexual Lubricant Causes Epithelial Damage in the Distal Colon: Potential Implication for HIV Transmission
Edward J. Fuchs, Linda A. Lee, Michael S. Torbenson, et al. The Journal of Infectious Diseases (2007)

 

Many sexual lubricants are hyperosmolar. Hyperosmolar enemas induce epithelial damage, and enema use has been associated with an increased risk of HIV infection. To inform the development of rectal microbicide formulation, we evaluated the effects of hyperosmolar gels on the rectal mucosa. Rectally applied hyperosmolar gels induce greater epithelial denudation and luminal secretion than iso-osmolar gels. Because denudation plausibly increases the risk of HIV transmission, hyperosmolar gels make poor rectal microbicide formulations, and hyperosmolar sexual lubricants may increase susceptibility to HIV infection.

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Surface characteristics of lactobacilli isolated from human vagina
Virginia Ocaña, Elena Bru, Aída A. P. De Ruiz Holgado, and María Elena Fatima Nader-Macías. The Journal of General and Applied Microbiology (1999)

 

In the present paper, the taxonomic classification of 134 lactobacilli isolates from vaginal samples of 200 women of Tucumán, Argentina, is reported. They were clustered in three metabolic groups of the genus Lactobacillus, most belonging to the obligately homofermentative group (56%), mainly represented by Lactobacillus delbrueckii subsp. delbrueckii and L. acidophilus. In the facultatively heterofermentative group (24%), the dominant species were L. paracasei subsp. paracasei and L. agilis, and in the obligately heterofermentative group (20%), L. brevis was the dominant species. All strains were studied for surface characteristics and adhesion-predicting properties. A correlation between the methods employed for hydrophobicity testing of the different isolates (Microbial Adhesion to Hydrocarbons and Salt Aggregation Test) is reported. Most strains were highly hydrophobic. Their hemagglutination capability with human erythrocytes was also tested, which was positive only for a few strains. Some isolates were self-aggregating. From our results, strains that shared the properties assayed were selected for further testing of some other desirable characteristics, such as antagonistic substance production, adhesion to biological substrates, and appropriate technological properties, to suggest the elaboration of a probiotic for the vaginal tract.

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Evidence for a curvilinear relationship between sympathetic nervous system activation and women's physiological sexual arousal
Tierney K. Lorenz, Christopher B. Harte, Lisa D. Hamilton, and Cindy M. Meston. Psychophysiology (2011)

 

There is increasing evidence that women's physiological sexual arousal is facilitated by moderate sympathetic nervous system (SNS) activation. Literature also suggests that the level of SNS activation may play a role in the degree to which SNS activity affects sexual arousal. We provide the first empirical examination of a possible curvilinear relationship between SNS activity and women's genital arousal using a direct measure of SNS activation in 52 sexually functional women. The relationship between heart rate variability (HRV), a specific and sensitive marker of SNS activation, and vaginal pulse amplitude (VPA), a measure of genital arousal, was analyzed. Moderate increases in SNS activity were associated with higher genital arousal, while very low or very high SNS activation was associated with lower genital arousal. These findings imply that there is an optimal level of SNS activation for women's physiological sexual arousal.

 

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Interaction of menstrual cycle phase and sexual activity predicts mucosal and systemic humoral immunity in healthy women
Tierney K. Lorenz, Gregory E. Demas, and Julia R. Heiman. Physiology & Behavior (2015) 

Several studies have documented shifts in humoral immune parameters (e.g., immunoglobulins) across the menstrual cycle in healthy women. It is thought that these shifts may reflect dynamic balancing between reproduction and pathogen defense, as certain aspects of humoral immunity may disrupt conception and may be temporarily downregulated at ovulation. If so, one could expect maximal cycle-related shifts of humoral immunity in individuals invested in reproduction – that is, women who are currently sexually active – and less pronounced shifts in women who are not reproductively active (i.e., abstinent). We investigated the interaction of sexual activity, menstrual cycle phase, and humoral immunity in a sample of 32 healthy premenopausal women (15 sexually active, 17 abstinent). Participants provided saliva samples during their menses, follicular phase, ovulation (as indicated by urine test for LH surge), and luteal phase, from which IgA was assayed. Participants also provided blood samples at menses and ovulation, from which IgG was assayed. Sexually active participants provided records of their frequency of sexual activity as well as condom use. At ovulation, sexually active women had higher IgG than abstinent women (d = 0.77), with women reporting regular condom use showing larger effects (d = 0.63) than women reporting no condom use (d = 0.11). Frequency of sexual activity predicted changes in IgA (Cohen's f2 = 0.25), with women reporting high frequency of sexual activity showing a decrease in IgA at ovulation, while women reporting low frequency or no sexual activity showing an increase in IgA at ovulation. Taken together, these findings support the hypothesis that shifts in humoral immunity across the menstrual cycle are associated with reproductive effort, and could contribute to the mechanisms by which women's physiology navigates tradeoffs between reproduction and immunity.


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Partnered sexual activity moderates menstrual cycle–related changes in inflammation markers in healthy women: an exploratory observational study
Tierney Lorenz, Gregory E.Demas, and Julia R.Heiman. Fertility and Sterility (2017)

 

OBJECTIVE:
To examine differences in inflammation markers in sexually active versus abstinent women and observe changes in inflammation markers across the menstrual cycle. Cycle-related immune fluctuations may have evolved to reduce interference with conception. If so, reproductively active (i.e., sexually active) women should show the most variability in cytokine expression.
DESIGN:
Participants provided serum samples at menses and ovulation (from which cytokines were assayed) and saliva samples at menses and during follicular, ovulation, and luteal phases (from which C-reactive protein [CRP] was assayed). Participants self-reported intercourse frequency during the study.
SETTING:
Academic research laboratory.
PATIENT(S):
Thirty-two healthy, naturally cycling premenopausal women (sexually active, n = 15; abstinent, n = 17).
INTERVENTION(S):
Observational study.
MAIN OUTCOME MEASURE(S):
Levels of proinflammatory cytokines (interleukin-6 [IL-6], interferon γ [IFN-γ], tumor necrosis factor-α [TNF-α]), an anti-inflammatory cytokine (interleukin-4 [IL-4]), and a marker of total inflammation (CRP).
RESULT(S):
Sexually active women had higher levels of all of the immune markers measured, including both pro- and anti-inflammatory cytokines, than abstinent women. Relative to sexually active women, abstinent women had less change across the menstrual cycle in levels of CRP. Among sexually active women, higher intercourse frequency predicted greater midcycle decreases in CRP, IL-6, and IFN-γ and midcycle increases in IL-4.
CONCLUSION(S):
Sexual activity may stimulate a complex interaction between pro- and anti-inflammatory cytokines that subsequently drives midcycle declines in inflammation.

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Acute Exercise Improves Physical Sexual Arousal in Women Taking Antidepressants
Tierney A. Lorenz, and Cindy M. Meston. Annals of Behavioral Medicine (2012)


Background
Antidepressants can impair sexual arousal. Exercise increases genital arousal in healthy women, likely due to increasing sympathetic nervous system (SNS) activity.
Purpose
Test if exercise increases genital arousal in women taking antidepressants, including selective serotonin reuptake inhibitors (SSRIs), which suppress SNS activity, and selective serotonin and norepinephrine reuptake inhibitors (SNRIs), which suppress the SNS less.
Method
Women reporting antidepressant-related sexual arousal problems (N = 47) participated in three counterbalanced sessions where they watched an erotic film while we recorded genital and SNS arousal. In two sessions, women exercised for 20 min, either 5 or 15 min prior to the films.
Results
During the no-exercise condition, women taking SSRIs showed significantly less genital response than women taking SNRIs. Exercise prior to sexual stimuli increased genital arousal in both groups. Women reporting greater sexual dysfunction had larger increases in genital arousal post-exercise. For women taking SSRIs, genital arousal was linked to SNS activity.
Conclusions
Exercise may improve antidepressant-related genital arousal problems.

 

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Pathogenesis of abnormal vaginal bacterial flora
Gilbert G. Donders, Eugene Bosmans, Alfons Dekeersmaecker, Annie Vereecken, Ben Van Bulck, and Bernard Spitz. American Journal of Obstetrics & Gynecology (2000)

 

Objective: This study was undertaken to determine the relationships between microscopy findings on wet mounts, such as lactobacillary grade or vaginal leukocytosis, and results of vaginal culture, lactate and succinate content of the vagina, and levels of selected cytokines. Study Design: In a population of 631 unselected women seeking treatment at an obstetrics and gynecology outpatient clinic, vaginal fluid was obtained by wooden Ayre spatula for wet mounting and pH measurement, by high vaginal swab for culture, and by standardized vaginal rinsing with 2 mL 0.9% sodium chloride solution for measurements of lactate, succinate, interleukin 1β, interleukin 8, leukemia inhibitory factor, and interleukin 1 receptor antagonist concentrations. Lactate and succinate levels were measured by gas-liquid chromatography and the cytokine concentrations were measured by specific immunoassays. Both univariate analysis (Student t test, Welch test, χ2 test, and Fisher exact test) and multivariate regression analysis (Cox analysis) were used. Results: Increasing disturbance of the lactobacillary flora (lactobacillary grades I, IIa, IIb, and III) was highly correlated with the presence of Gardnerella vaginalis, Trichomonas vaginalis, enterococci, group B streptococci, and Escherichia coli. Vaginal pH and interleukin 8 and interleukin 1β concentrations increased linearly with increasing lactobacillary grade, whereas lactate concentrations and the presence of epithelial cell lysis decreased. A similar pattern of associations with increasing leukocyte count was clear, but in addition there was an increase in leukemia inhibitory factor concentration. Multivariate analysis of vaginal leukocytosis, lactobacillary grades, and the presence of positive vaginal culture results showed that interleukin 1β concentration was most closely related to the lactobacillary grade, leukemia inhibitory factor concentration was most closely related to the lactobacillary grade and positive culture results, interleukin 8 concentration was most closely related to positive culture results, and interleukin 1 receptor antagonist concentration was most closely related to vaginal leukocytosis and positive culture results. The concentration ratio of interleukin 1β to interleukin 1 receptor antagonist remained stable, except when vaginal leukocytosis increased. In its most severe form, with >10 leukocytes per epithelial cell present, a decompensation of the vaginal flora with a collapse in interleukin 1β and interleukin 1 receptor antagonist concentrations was seen, but there was a concurrent sharp increase in leukemia inhibitory factor concentration. This pattern was completely different from the course of the cytokine concentrations associated with a lactobacillary grade increase. Conclusion: Both disturbed lactobacillary grade and the presence of increasing vaginal leukocytosis were correlated with lactobacillary substrate (lactate) concentration, pH, and the concentrations of a variety of cytokines. There was a remarkably linear increase in these cytokines as either leukocytosis or lactobacillary grade became more severe. In circumstances in which leukocytosis was extreme, however, interleukin 1β was no longer produced but leukemia inhibitory factor concentrations increased. We speculate that in extreme inflammation the body tries to limit the damage that can be done by exaggerated cytokine production.

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Is there a protective role for vaginal flora?
Jack D. Sobel. Current Infectious Disease Reports (1999)



The notion of a protective vaginal flora is relatively new. Resident flora manifest colonization resistance to prevent or reduce the likelihood of exogenous microorganisms, viruses, bacteria, yeast, or parasites becoming established in the lower genital tract of women following sexual (HIV, Neisseria gonorrhoeae, Escherichia coli, Candida albicans, Trichomonas vaginalis) or nonsexual (uropathogenic E. coli) transmission. The concept of preserving or reestablishing protective flora has been hastened by several factors, including the potential widespread use of vaginal microbicides, the increased heterosexual spread of HIV, and the imminent availability of exogenous Lactobacillus species probiotic therapy.


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Characterization of the vaginal microflora in health and disease
Raluca Datcu. Danish Medical Journal (2004)


BACKGROUND:
Bacterial vaginosis (BV) is an imbalance of the vaginal bacterial microbiota and its aetiology is still unknown. Our aims were to investigate the diagnostic potential of species/genus specific quantitative PCR (qPCR) for bacteria present in swabs and first-void urine (FVU) samples using Nugent's and Claeys' criteria and 454 sequencing of the vaginal microbiome as reference.
METHODS:
Self-collected swabs, vaginal smears and FVU were obtained from 177 women from Greenland (Study I and III) and physician-collected vaginal swabs and smears were obtained from 163 Swedish women (Study II). BV was diagnosed by Nugent's criteria in Study I and III and by Amsel's criteria in Study II. The vaginal swabs and FVU samples were analysed by qPCR for selected vaginal bacteria in all three studies and for four sexually transmitted infections (STIs) in Study I.
RESULTS:
Study I: STIs were common in women from Greenland and BV was found in 45% of these women but was not associated with individual STIs. In multivariate logistic analysis, Atopobium vaginae and Prevotella spp. were both independently associated with BV in swabs. BV could be subdivided into clusters dominated by a single or a few species together. Seven vaginal bacteria (A. vaginae, Prevotella spp. Gardnerella vaginalis, Bacterial vaginosis associated bacterium (BVAB) 2, Eggerthella-like bacterium, Leptotrichia amnionii and Megasphaera type 1) had areas under the receiver operating characteristic (ROC) curve > 85% in swabs, suggesting that they were good predictors of BV according to Nugent. Study II: For the majority of species/genera, the kappa values indicated fair to good agreement when their presence was determined by 454 pyrosequencing versus real-time PCR. The same seven vaginal bacteria as found in Study I, had areas under the ROC-curve > 85% in swabs from Swedish women, demonstrating a good diagnostic accuracy for BV according to Amsel. Study III: In a multivariate model, Megasphaera type 1 and Prevotella spp. remained significantly associated with BV in FVU samples. A linear regression analysis showed good agreement between bacterial load from swabs and FVU, but Prevotella spp. could be detected in high numbers in a few FVU samples without being present in swabs. After applying ROC curve analysis, the same seven vaginal bacteria as previously mentioned showed good prediction for BV according to Nugent in FVU. BV could be detected with comparable sensitivity in FVU and vaginal swabs.
CONCLUSION:
BV can be diagnosed by molecular methods performed either on swabs or urine but it is important to apply thresholds in order to improve the accuracy of the diagnosis. Furthers it was possible to identify clusters of BV dominated by single or paired bacteria, and these clusters could classify BV into subgroups, providing a more detailed understanding of the condition. Seven vaginal bacteria were highly accurate for BV diagnosis both in swabs and FVU. Finally a good agreement between Nugent and Claeys was found.


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