Efficacy and safety of low-dose regimens of conjugated estrogens cream administered vaginally.

Abstract

OBJECTIVE:

The aim of this study was to evaluate the efficacy and safety of low-dose conjugated estrogens (CE) cream for treatment of atrophic vaginitis.

METHODS:

Postmenopausal women (N = 423) with moderate-to-severe vaginal atrophy were randomized to CE cream 0.3 mg or placebo once daily (21 days on/7 days off) or twice weekly for 12 weeks, followed by open-label treatment with CE cream for 40 weeks consistent with their prior regimen. Primary endpoints were changes in vaginal maturation index (VMI; percentage of superficial cells), vaginal pH, and severity of participant-reported most bothersome symptom (vaginal dryness, itching, burning, or dyspareunia) at week 12. Endometrial safety was assessed by transvaginal ultrasound and endometrial biopsy for 52 weeks.

RESULTS:

At week 12, improvements in VMI with daily and twice-weekly use of low-dose CE cream (27.9% and 25.8%, respectively) were significantly greater compared with placebo (3.0% and 1.0%, respectively; P < 0.001). Improvements in vaginal pH with daily and twice-weekly CE cream (-1.6 for both) were also significantly greater relative to placebo (-0.4 and -0.3, respectively; P < 0.001). VMI and vaginal pH responses were sustained through 52 weeks. Both CE cream regimens significantly reduced most bothersome symptom scores compared with placebo (P < or = 0.001), including those for dyspareunia (P < or = 0.01). There was no report of endometrial hyperplasia or carcinoma. Adverse events occurred with similar frequency among the active and placebo groups during the double-blind phase.

CONCLUSIONS:

Daily and twice-weekly use of low-dose CE cream was equally effective in relieving symptoms of vulvovaginal atrophy. Both regimens showed endometrial safety and sustained efficacy during 1 year of therapy.

• Authors: Gloria Bachmann, Céline Bouchard, Diana Hoppe, Radhika Ranganath, Corrado Altomare, Alberta Vieweg, Jay Graepel, Eileen Helzner
• Journal: Menopause (New York, N.Y.) (Menopause) 2009 Jul-Aug Vol. 16 Issue 4 Pg. 719-27 ISSN: 1530-0374 [Electronic] United States
• PMID: 19436223 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Estrogens, Conjugated (USP)
• Placebos
• Vaginal Creams, Foams, and Jellies

Topics

• Administration, Intravaginal
• Aged
• Aged, 80 and over
• Double-Blind Method
• Endometrial Hyperplasia (chemically induced, diagnostic imaging, pathology)
• Endometrium (diagnostic imaging, drug effects, pathology)
• Estrogens, Conjugated (USP) (administration & dosage, adverse effects)
• Female
• Humans
• Hydrogen-Ion Concentration
• Middle Aged
• Placebos
• Postmenopause
• Ultrasonography
• Vaginal Creams, Foams, and Jellies (administration & dosage)
• Vaginitis (drug therapy)