A guide to lotions and potions for treating vaginal atrophy
Options for relieving the related itching, dryness, burning, and dyspareunia include a variety of hormonal formulations and nonhormonal alternatives
IN THIS ARTICLE
What to offer when estrogen is not an option
Some women may want to avoid hormonal treatment, or have a contraindication to it, such as estrogen-receptor–positive breast cancer.8 In premenopausal women, vaginal atrophy can occur with lactation or postpartum hormonal changes, or may result from the use of anti-estrogenic agents for breast cancer. Other candidates for nonhormonal therapy are women who have chronic vulvar pain syndromes. In these women, vaginal lubricants can be especially useful.
Although they are less effective than estrogen, vaginal moisturizers, such as Replens, have been shown to reverse symptoms of vaginal atrophy and decrease discomfort during intercourse.9
The therapeutic options for vaginal atrophy are likely to broaden in the near future. Ospemifene (Ophena), a selective estrogen receptor modulator (SERM) under development for the treatment of vaginal atrophy, has reached the end of Phase-3 clinical study, with positive efficacy results. A long-term safety study of the orally administered SERM has also been completed, reports QuatRx, the drug’s manufacturer. The company expects to file a New Drug Application with the US Food and Drug Administration early next year.
Phase-3 trials documented significant improvement in dryness, dyspareunia, and other endpoints
The first Phase-3 study of Ophena was announced by QuatRx in January 2008 and presented at the 90th annual meeting of the Endocrine Society. Women who were treated with 60 mg daily of Ophena experienced statistically significant improvement in vaginal dryness, dyspareunia, and the proportion of parabasal and superficial cells in the epithelium of vaginal walls. The vaginal pH level also declined. The drug did not cause hot flushes among users.
The second Phase-3 study was a randomized, double-blind, placebo-controlled study of 919 women who had vulvovaginal atrophy. It was conducted at 116 sites in the United States. Among the cohort of 605 women who identified dyspareunia as their most bothersome symptom, positive efficacy results were achieved in all four primary endpoints, including:
- a decrease in parabasal cells
- an increase in superficial cells
- a decrease in the vaginal pH level
- improvement in dyspareunia.
The trial demonstrated statistically significant improvement from baseline to week 12 in all four endpoints, compared with placebo (P<.0001>
All women were supplied with a nonhormonal vaginal lubricant to be used as needed during the treatment period; the study found efficacy above and beyond usage of this lubricant, according to a press release from QuatRx.
Is the benefit worth the risk?
Some have questioned whether a systemic drug is overkill for a complaint like postmenopausal vaginal atrophy.14 Because Ophena is a SERM, it is likely to carry a cardiovascular risk profile similar to that of other drugs in its class. For example, in a large randomized trial, raloxifene (Evista) failed to reduce coronary artery disease and significantly increased the incidence of fatal stroke and venous thromboembolism.15 When local estrogen formulations that do not carry such risks are already available, some experts question the advisability of developing another systemic agent.
Another question: Is it realistic to expect the patient to take a drug every day when her chief complaint is postmenopausal dyspareunia and she is likely to have intercourse only once or twice a week?
These questions probably won’t be addressed until the drug enters the market—and physicians and their patients will be the ones providing the answers.
Specialty lubricants are unproven
In contrast to products designed to treat vaginal dryness and atrophy, some lubricants are marketed specifically for sexual enhancement. Warming lubricants cause a heating sensation on the skin and usually contain menthol, L-arginine, or capsaicin. Natural and artificial flavors are used to manufacture flavored lubricants.
None of these products have been scientifically proven to enhance sexual function.
Oil-based lubricants may impede condom integrity
It is estimated that 40% of couples who use condoms also use a lubricant to assist with intercourse.10 The integrity of latex condoms has been shown to deteriorate with the use of an oil-based lubricant or petrolatum. One study, in which the mean burst time of condoms was assessed during pressurized air inflation, showed a significant reduction in that time when vaginal lubricants that contained mineral or vegetable oil were used.11
Oil-based lubricants also have been shown to increase the slippage rate, with a trend toward increased breakage.10
Water-based lubricants may slightly increase slippage, but they reduce breakage.
Women should avoid oil-based lubricants when their partner uses a condom.
Some lubricants affect sperm quality
Choosing a vaginal lubricant can be of particular concern to a woman who is being treated for infertility. Lubricants may affect the integrity and function of sperm, even if they do not contain spermicide. Noncommercial products, such as glycerin, olive oil, vegetable oil, and, even, saliva have been associated with a loss of sperm function.12
