BALTIMORE – , according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. In a secondary analysis also presented at the meeting, the lubricants were found not to alter the vaginal microbiome.
Using these types of lubricants during vaginal intercourse at least once a week over a 4-week period resulted in a statistically significant increase of over four points in the 36-point Female Sexual Function Index (FSFI), a self-reported measure of sexual functioning, for participants, said Michael Krychman, MD, executive director of the Southern California Center for Sexual Health and Survivorship Medicine, Newport Beach, the senior author of the study. Statistically significant improvements also were observed in individual areas such as sexual desire and arousal, orgasm, and satisfaction. Results of the study have been published in the Journal of Sexual Medicine.
In the open-label, five-arm, parallel study conducted in Germany, 174 women aged 18-65 years were randomly assigned to use one of five lubricants from three popular brands. After a 4-week run-in period with no use of lubricants, participants were shown how to apply the products and instructed to use the substances during vaginal intercourse at least once a week over a 4-week period.
Participants reported experiencing mild to moderate vaginal dryness and dyspareunia during vaginal intercourse within the previous 3 months.
Statistically significant improvements were seen across all six individual domain scores of the FSFI (desire, arousal, lubrication, orgasm, satisfaction, and pain reduction) from baseline to week 4 with all five lubricants (P < .0001 for lubrication and pain reduction; P < .05 for desire, arousal, orgasm, and satisfaction), according to the researchers.
After 4 weeks, a clinically meaningful improvement in the total FSFI score was observed for four lubricants among premenopausal women and for all lubricants among postmenopausal women. The percentage of participants with sexual function as defined as a score of at least 26.55 on the FSFI was significantly greater after treatment (76.9%) than before treatment (20.8%; P < .0001).
“You would assume if you’re using lubricant it would improve the dryness, but what was very exciting for us is that it improved desire, it improved orgasm, it improved arousal,” Dr. Krychman said in an interview. Like concentric overlapping circles of female sexual function, he said, “if you improve one aspect, you improve the other.”
Nearly 80 nonserious adverse effects occurred in 43 participants, five of which were thought to be possibly attributed to the products, such as vulvovaginal burning, itching, or discomfort. In questionnaires, most women agreed that using the lubricants made sex more enjoyable and provided an overall pleasant experience.
One limitation of the study is that because most participants were Caucasian, the results may not be generalizable to all populations, according to the researchers. Further research is required to fully determine safety and efficacy in patients of all races and ethnicities, they reported, especially given that vaginal dryness has been reported more frequently in non-White ethnic groups.
In a companion presentation, Dr. Krychman discussed another aspect of the study looking at the lubricants’ effects on the vaginal microbiome. Repeated application of the products did not significantly alter the vaginal microbiome for up to 4 weeks, and vaginal pH slightly increased in all treatment groups shortly after use but was restored in most cases after a day.
Water-based lubricants are recommended by the WHO for use with condoms because they do not erode latex, said Karen Adams, MD, professor emeritus of obstetrics and gynecology and founding director of the Menopause and Sexual Medicine Program at Oregon Health & Science University, Portland. Guidelines from the group recommend lubricants should have an osmolality that is as close to normal vaginal secretions as possible to decrease the likelihood of irritation or other side effects, she said. Some available lubricants have four to six times that osmolality, which potentially could dehydrate cells, achieving the opposite of the desired effect.
“The reason this is important is they’re trying to develop lubricants that are more ‘vaginal friendly’ and more in line with the WHO guidelines,” said Dr. Adams, who is joining Stanford (Calif.) University in July to create and lead a new program in menopause and healthy aging. “They came up with four formulas consistent with WHO guidelines to see if these new ones worked at least as well [as commercially available products with higher osmolality], and it turns out they did,” she said. “They worked just fine.”
The study was funded by Reckitt Healthcare. Dr. Krychman is a paid medical consultant for the company. Dr. Adams disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.