Meeting NewsPerspective

Moisturizers, lubricants provide relief for vulvovaginal atrophy symptoms

PHILADELPHIA — Vaginal lubricants and moisturizers and intravaginal DHEA can provide relief from symptoms of vulvovaginal atrophy, according to a presenter at the Annual Meeting of the North American Menopause Society.

“Despite having an aging population, it’s an area that continues to be extremely poorly managed. Women are reluctant to come forward, to complain of symptoms of [vulvovaginal atrophy]. They still view the topic as being taboo, and I think a lot of health care professionals are fearful of over-conversation, perhaps in some cases because of a lack of knowledge about the options,” Nick Panay, MSc, MBBS, MRCOG, MFSRH, of the West London Menopause and PMS Centre at Queen Charlotte’s and Chelsea Westminster Hospital, London, said during his presentation. “I think we just have to normalize it.”

More than half of postmenopausl women will likely experience some symptoms of vulvovaginal atrophy, and many will not raise the topic with their health care provider, Panay said.

According to recent guidelines and position statements, women with vaginal dryness can use moisturizers and lubricants alone or in addition to vaginal estrogen.

Several over-the-counter moisturizers and lubricants are available to women in addition to estrogen and the recently approved prasterone (Intrarosa, Endoceutics Inc.), also known as dehydroepiandrosterone or DHEA.

“I think that women should have a choice. Whenever I see a new preparation hitting the market, I always like to evaluate its evidence base, its usefulness, but I’m generally glad we’re expanding our armory so that we have something for everyone, and each woman can then make a choice in their individualized treatment,” Panay said.

In a recent study, Panay and colleagues, examined pH and osmolality — which is the measure of dissolved particles per unit of water — of commonly available moisturizers and lubricants.

Infection, irritation

In a healthy woman, vaginal pH is 3.8 to 4.5; however, many products the researchers eevaluated were well outside this range, Panay said. If vaginal pH is altered by lubricants with pH greater than 4.5, it may lead to recurrent urinary tract infection, thrush or bacterial vaginosis. Lubricants with a low pH may irritate vaginal mucosa.

“None of these products have this information on label; you actually have to contact the manufacturers for this information or perform tests in laboratories to test the pH of these preparations,” Panay said.

In terms of osmolality, Panay was looking for hypo-osmotic products, so that the water flows into the cells, or iso-osmotic products, which function more like cells of the mucous membrane. The optimal osmolality is less than 380 mOsm/kg.

As with pH, most of the preparations available fell well above this range, with some products exceeding 2,000 mOsm/kg. WHO set a recommended osmolality for personal lubricants of less than 380 mOsm/kg, but set a pragmatic range of less than 1,200 mOsm/kg; however, a significant number of products exceed that cut-off, Panay said.

Panay expressed concern about the labelling of these over-the-counter products, which do not currently have labels that contain information about pH or osmolality.

“I think there needs to be a type mark, for instance, to indicate the optimum physiological range of pH and osmolality and also that they’re free from potentially harmful additives,” Panay said. “I feel sorry for women who walk into these pharmacies, and they see hundreds of products to choose from. How on earth do they choose? So, we need to regulate the labeling of these products to make it entirely clear what’s in them and to allow them to make an as informed choice with over-the-counter medications as they do with regulated medications.”

Recommendations for treatment of vaginal dryness

Estrogens should be the first-line therapy for vaginal dryness, according to Panay. However, women may be opposed to or have counter-indications to using estrogen, including aromatase inhibitors.

Common products, such as hyaluronic acid lubricants and the vaginal lubricant Replens, can benefit women with vulvovaginal atrophy symptoms. They particularly have a role in precoital lubrication. The benefit of these products is that women cannot overdose, according to Panay.

“Overall, the data on efficacy on moisturizers and lubricants do suggest at least transient symptomatic relief on vaginal atrophy symptoms. They do seem to have a significant role with regards to lubrication and may be a treatment of vaginal atrophy for women who do not wish to, or cannot, use hormone therapy,” Panay said.

Panay made serval recommendations based on his study of pH and osmolality. For urogenital atrophy, elevated vaginal pH or pain due to dryness, he recommended a vaginal moisturizer with pH at least 3 and osmolality below 380 mOsm/kg. A vaginal lubricant, with appropriate pH and osmolality, is recommended to treat dyspareunia. In women with urogenital atrophy as a result of cancer treatment, with an estrogen counterindication or in combination with topical estrogen, a paraben-free vaginal moisturizer or lubricant can be used.

DHEA products

Panay concluded his presentation by talking about DHEA, which is available in the U.S. but not yet in Europe. DHEA is indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, and is administered as a vaginal insert at bedtime. In several trials, DHEA was found to decrease percentage of parabasal cells and increase percentage of superficial cells. Both vaginal pH and pain during sexual activity decreased significantly.

Female sexual function was studied using a questionnaire at baseline, 26 weeks and 52 weeks in one trial of DHEA. Researchers found significant improvements in the domains of desire, arousal, lubrication, orgasm, satisfaction and pain by 28%, 49%, 115%, 51%, 41% and 108%, respectively, at 52 weeks vs. baseline, according to Panay.

Overall, many products, including moisturizers, lubricants and DHEA, are available to women to treat symptoms of vulvovaginal atrophy.

“Vaginal moisturizers and lubricants are not merely a quick fix, but can be used longer term. But we have to recognize that there are limitations, and they are not a cure for [vulvovaginal atrophy]. Moisturizers and lubricants can provide relief from symptoms, but only local estrogen therapy can address the underlying pathology of [vulvovaginal atrophy],” Panay concluded. “It’s important to educate women about [vulvovaginal atrophy] and to encourage them to make informed choices.” by Cassie Homer

Reference:

Panay N, et al. Treating Vulvovaginal Atrophy/Genitourinary Syndrome of Menopause: Lubricants, Moisturizers, and Vaginal DHEA. Presented at: Annual Meeting of the North American Menopause Society; Oct. 11-14, 2017; Philadelphia.

Disclosures: Panay reports lecturing and advising for Abbott, Bayer, Besins, MDS, Mithra, Mylan, Novo Nordisk, Pfizer, SeCur and Shionogi.

PHILADELPHIA — Vaginal lubricants and moisturizers and intravaginal DHEA can provide relief from symptoms of vulvovaginal atrophy, according to a presenter at the Annual Meeting of the North American Menopause Society.

“Despite having an aging population, it’s an area that continues to be extremely poorly managed. Women are reluctant to come forward, to complain of symptoms of [vulvovaginal atrophy]. They still view the topic as being taboo, and I think a lot of health care professionals are fearful of over-conversation, perhaps in some cases because of a lack of knowledge about the options,” Nick Panay, MSc, MBBS, MRCOG, MFSRH, of the West London Menopause and PMS Centre at Queen Charlotte’s and Chelsea Westminster Hospital, London, said during his presentation. “I think we just have to normalize it.”

More than half of postmenopausl women will likely experience some symptoms of vulvovaginal atrophy, and many will not raise the topic with their health care provider, Panay said.

According to recent guidelines and position statements, women with vaginal dryness can use moisturizers and lubricants alone or in addition to vaginal estrogen.

Several over-the-counter moisturizers and lubricants are available to women in addition to estrogen and the recently approved prasterone (Intrarosa, Endoceutics Inc.), also known as dehydroepiandrosterone or DHEA.

“I think that women should have a choice. Whenever I see a new preparation hitting the market, I always like to evaluate its evidence base, its usefulness, but I’m generally glad we’re expanding our armory so that we have something for everyone, and each woman can then make a choice in their individualized treatment,” Panay said.

In a recent study, Panay and colleagues, examined pH and osmolality — which is the measure of dissolved particles per unit of water — of commonly available moisturizers and lubricants.

Infection, irritation

In a healthy woman, vaginal pH is 3.8 to 4.5; however, many products the researchers eevaluated were well outside this range, Panay said. If vaginal pH is altered by lubricants with pH greater than 4.5, it may lead to recurrent urinary tract infection, thrush or bacterial vaginosis. Lubricants with a low pH may irritate vaginal mucosa.

“None of these products have this information on label; you actually have to contact the manufacturers for this information or perform tests in laboratories to test the pH of these preparations,” Panay said.

In terms of osmolality, Panay was looking for hypo-osmotic products, so that the water flows into the cells, or iso-osmotic products, which function more like cells of the mucous membrane. The optimal osmolality is less than 380 mOsm/kg.

PAGE BREAK

As with pH, most of the preparations available fell well above this range, with some products exceeding 2,000 mOsm/kg. WHO set a recommended osmolality for personal lubricants of less than 380 mOsm/kg, but set a pragmatic range of less than 1,200 mOsm/kg; however, a significant number of products exceed that cut-off, Panay said.

Panay expressed concern about the labelling of these over-the-counter products, which do not currently have labels that contain information about pH or osmolality.

“I think there needs to be a type mark, for instance, to indicate the optimum physiological range of pH and osmolality and also that they’re free from potentially harmful additives,” Panay said. “I feel sorry for women who walk into these pharmacies, and they see hundreds of products to choose from. How on earth do they choose? So, we need to regulate the labeling of these products to make it entirely clear what’s in them and to allow them to make an as informed choice with over-the-counter medications as they do with regulated medications.”

Recommendations for treatment of vaginal dryness

Estrogens should be the first-line therapy for vaginal dryness, according to Panay. However, women may be opposed to or have counter-indications to using estrogen, including aromatase inhibitors.

Common products, such as hyaluronic acid lubricants and the vaginal lubricant Replens, can benefit women with vulvovaginal atrophy symptoms. They particularly have a role in precoital lubrication. The benefit of these products is that women cannot overdose, according to Panay.

“Overall, the data on efficacy on moisturizers and lubricants do suggest at least transient symptomatic relief on vaginal atrophy symptoms. They do seem to have a significant role with regards to lubrication and may be a treatment of vaginal atrophy for women who do not wish to, or cannot, use hormone therapy,” Panay said.

Panay made serval recommendations based on his study of pH and osmolality. For urogenital atrophy, elevated vaginal pH or pain due to dryness, he recommended a vaginal moisturizer with pH at least 3 and osmolality below 380 mOsm/kg. A vaginal lubricant, with appropriate pH and osmolality, is recommended to treat dyspareunia. In women with urogenital atrophy as a result of cancer treatment, with an estrogen counterindication or in combination with topical estrogen, a paraben-free vaginal moisturizer or lubricant can be used.

DHEA products

Panay concluded his presentation by talking about DHEA, which is available in the U.S. but not yet in Europe. DHEA is indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, and is administered as a vaginal insert at bedtime. In several trials, DHEA was found to decrease percentage of parabasal cells and increase percentage of superficial cells. Both vaginal pH and pain during sexual activity decreased significantly.

PAGE BREAK

Female sexual function was studied using a questionnaire at baseline, 26 weeks and 52 weeks in one trial of DHEA. Researchers found significant improvements in the domains of desire, arousal, lubrication, orgasm, satisfaction and pain by 28%, 49%, 115%, 51%, 41% and 108%, respectively, at 52 weeks vs. baseline, according to Panay.

Overall, many products, including moisturizers, lubricants and DHEA, are available to women to treat symptoms of vulvovaginal atrophy.

“Vaginal moisturizers and lubricants are not merely a quick fix, but can be used longer term. But we have to recognize that there are limitations, and they are not a cure for [vulvovaginal atrophy]. Moisturizers and lubricants can provide relief from symptoms, but only local estrogen therapy can address the underlying pathology of [vulvovaginal atrophy],” Panay concluded. “It’s important to educate women about [vulvovaginal atrophy] and to encourage them to make informed choices.” by Cassie Homer

Reference:

Panay N, et al. Treating Vulvovaginal Atrophy/Genitourinary Syndrome of Menopause: Lubricants, Moisturizers, and Vaginal DHEA. Presented at: Annual Meeting of the North American Menopause Society; Oct. 11-14, 2017; Philadelphia.

Disclosures: Panay reports lecturing and advising for Abbott, Bayer, Besins, MDS, Mithra, Mylan, Novo Nordisk, Pfizer, SeCur and Shionogi.

    Perspective
    Mary Jane Minkin

    Mary Jane Minkin

    Dr. Panay gave an excellent session on vulvovaginal atrophy or genitourinary syndrome of menopause (the advantage of using the official term is that it also focuses on the urinary symptoms associated with postmenopausal dryness). He addressed over-the-counter therapies, such as lubricants and moisturizers. He spoke about the issues involved in choosing the appropriate product. He emphasized that keeping the vaginal pH in a normal range is ideal (pH between 3.8 and 4.5). He also discussed the osmolality of the product.

    Panay discussed the newest product on the scene in U.S. — this product is not available yet in Europe. The new product is vaginal DHEA, which is marketed as Intrarosa. Placed daily as a vaginal suppository, it significantly helped moisture and discomfort. The DHEA is absorbed into the vaginal mucosa and is metabolized intracellularly to both estrogen and testosterone, and then broken down intracellularly as well. (The process is called “intracrinology” — as opposed to exocrine or endocrine.)

    Many women are suffering in silence with vulvovaginal atrophy, and all clinicians should be enquiring of their peri- and postmenopausal women to see if they are having vulvovaginal atrophy complaints. We do have many options these days for our patients. Over-the-counter remedies are readily available. If these are not effective, we of course have vaginal estrogens, in many forms. But we now have a vaginal non-estrogen therapy in DHEA, and we also have an oral non-estrogen therapy (oral Ospemifene, a SERM) all of which have excellent efficacy and safety data. So, there is truly something available for just about everyone.

    • Mary Jane Minkin, MD, FACOG
    • Clinical professor, Department of Obstetrics, Gynecology and Reproductive Sciences, Yale Medical School

    Disclosures: Minkin reports consulting for Nature's Way, Novo Nordisk, Pfizer and Shionogi.

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