Low-dose (0.3 mg) synthetic conjugated estrogens A is effective for managing atrophic vaginitis.

Abstract

OBJECTIVE:

Estrogen or combined hormone (estrogen-progestin) therapy is highly efficacious for managing the signs and symptoms of urogenital atrophy. A low, effective estrogen dose may enhance patient acceptance and reduce side effects.

METHODS:

In this randomized, double-blind, multicenter clinical trial, 71 healthy postmenopausal women with vaginal atrophy (Vaginal Maturation Index < or =55) received either low-dose synthetic conjugated estrogens, A tablets (Cenestin) (SCE-A), 0.3 mg once daily, or placebo for 16 weeks.

RESULTS:

Treatment with SCE-A for 16 weeks resulted in a highly significant (P<0.0001) mean increase of 17.7 in the Vaginal Maturation Index compared to a mean increase of 4.1 with placebo treatment. A significant estrogenic improvement was detected as early as 4 weeks (mean increase 14.6). Superficial cells were significantly increased from 2.1% at baseline to 15.9% at week 16 with SCE-A, and parabasal cells were significantly reduced from 23.0% at baseline to 1.6% at week 16 (P<0.01 between treatments for both). Vaginal pH was significantly decreased from 6.2 at week -2 to 5.2 at week 16 with SCE-A compared to placebo (P<0.0001). There were no significant differences between treatment groups in the incidence of treatment-emergent side effects or other measures of safety, except for urinary tract infection, which occurred more frequently in the placebo group.

CONCLUSIONS:

These results confirm the relatively rapid estrogenic effect and safety of a low-dose (0.3 mg/day) of slow-release SCE-A (Cenestin) in the treatment of vaginal atrophy in postmenopausal women.

• Authors: Phyllis Marx, George Schade, Shelby Wilbourn, Stephen Blank, Dean L Moyer, Robert Nett
• Journal: Maturitas (Maturitas) Vol. 47 Issue 1 Pg. 47-54 (Jan 20 2004) ISSN: 0378-5122 [Print] Ireland
• PMID: 14706765 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Estradiol Congeners
• Estrogens
• Estrogens, Conjugated (USP)
• estrogens, conjugated synthetic A

Topics

• Adult
• Aged
• Aged, 80 and over
• Atrophy (drug therapy, etiology)
• Estradiol Congeners
• Estrogens (administration & dosage, adverse effects, therapeutic use)
• Estrogens, Conjugated (USP) (administration & dosage, adverse effects, therapeutic use)
• Female
• Humans
• Hydrogen-Ion Concentration
• Middle Aged
• Postmenopause (drug effects)
• Treatment Outcome
• Vagina (chemistry, drug effects, pathology)
• Vaginitis (drug therapy, pathology)