Estradiol Vaginal Insert Provides Early Relief of Postmenopausal Vulvar and Vaginal Atrophy

By Will Boggs MD

September 17, 2019

NEW YORK (Reuters Health) - A new 17beta-estradiol softgel vaginal insert relieves postmenopausal vulvar and vaginal atrophy (VVA) in as little as two weeks, according to findings from the REJOICE trial.

"I believe that the ease of use, efficacy, and low dose help to position this as a first-line treatment for women with symptomatic VVA," Dr. Ginger Constantine from EndoRheum Consultants, LLC, in Malvern, Pennsylvania, told Reuters Health by email.

The reported prevalence of VVA during menopause is as high as 47%. Low-dose vaginal estrogens have been shown to provide genitourinary symptom relief with minimal systemic absorption.

Dr. Constantine and colleagues assessed responder rates of TX-004HR (Imvexxy) 4-ug, 10-ug, and 25-ug estradiol softgel vaginal inserts at week 2 of treatment and tested whether week-2 findings predicted response at week 12 in 695 postmenopausal women with moderate to severe dyspareunia.

The proportion of responders (defined as having at least two of three clinical endpoints: vaginal superficial cells >5%, vaginal pH <5.0, and improvement from baseline of at least one dyspareunia category) was significantly higher in the estradiol groups than in the placebo group at week 2 (74% with 4 ug, 81% with 10 ug and 82% with 25 ug vs. 24% with placebo).

This difference persisted at week 12 (72%, 80% and 79%, respectively, with estradiol inserts vs. 33% with placebo), the researchers report in Menopause, online August 19.

Most women in the estradiol groups who were responders at week 2 (85%) were also responders at week 12, whereas 46% of nonresponders at week 2 were responders at week 12.

Being a responder at week 2 was associated with 7.9-fold greater odds of having a positive response at week 12, compared with being a nonresponder at week 2.

"These data may be able to help inform clinicians counseling postmenopausal women with moderate to severe dyspareunia regarding the benefits and potential early therapeutic effect of the low-dose estradiol softgel vaginal insert," the researchers conclude.

Dr. Constantine added, "There was high patient satisfaction with Imvexxy."

The 4- and 10-ug inserts are approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe dyspareunia associated with postmenopausal VVA.

TherapeuticsMD funded the study, employed three of the authors, and had various relationships with the rest, including Dr. Constantine.


Menopause 2019.