This is the current release of the guideline.

Vaginal atrophy in postmenopausal women

Assessment of Therapeutic Effectiveness
Management
Treatment

Endocrinology
Family Practice
Geriatrics
Internal Medicine
Obstetrics and Gynecology
Oncology
Urology

Advanced Practice Nurses
Allied Health Personnel
Health Care Providers
Health Plans
Managed Care Organizations
Nurses
Pharmacists
Physician Assistants
Physicians

To create an evidence-based position statement published by The North American Menopause Society (NAMS) on the role of local vaginal estrogen therapy (ET) for the treatment of vaginal atrophy in postmenopausal women

Postmenopausal women

Evaluation

Pretreatment evaluation including comprehensive history and physical examination

Treatment

1. Nonhormonal vaginal lubricants and moisturizers
2. Local vaginal estrogen (estradiol vaginal cream, conjugated estrogens [CE] vaginal cream, estradiol vaginal ring, estradiol hemihydrate vaginal tablet)

• Symptom relief
• Quality of life
• Adverse effects of treatment

Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases

For this position statement, The North American Menopause Society (NAMS) systematically reviewed the relevant medical literature. Using the MEDLINE database, a search was made for clinical trials, meta-analyses, and clinical practice guidelines published in English and related to vaginal ET for vaginal atrophy in postmenopausal women. The Medical Subject Headings used for the search were postmenopause, physiological sexual dysfunction (including dyspareunia, vaginismus, and vaginitis), and vaginal disease, with subheadings of epidemiology, etiology, diagnosis, prevention, control, and therapy. The National Guideline Clearinghouse was searched for relevant clinical practice guidelines, and the Cochrane Library was searched for relevant systematic reviews. Priority was given to evidence from randomized controlled clinical trials and to meta-analyses of such trials, followed by evidence from controlled observational studies, using criteria described elsewhere. Conclusions from other evidence-based guidelines were also reviewed. Because standards of care and treatment options differ throughout the world, the focus was limited to therapies available in North America.

Not stated

Expert Consensus

Not applicable

Review of Published Meta-Analyses
Systematic Review with Evidence Tables

Not stated

Expert Consensus

In developing this position statement, The North American Menopause Society (NAMS) enlisted a five-person Editorial Board composed of experts in endocrinology, gynecology, and female genital diseases. The Editorial Board reviewed, synthesized, and interpreted the published data, developed conclusions, and made recommendations. If the evidence was contradictory or inadequate to form a conclusion, a consensus-based opinion was established. (Practice parameter standards related to NAMS position statements have been described in an editorial [see "Availability of Companion Documents" field in this summary]).

Not applicable

A formal cost analysis was not performed and published cost analyses were not reviewed.

Internal Peer Review

This position statement was edited, modified, and subsequently approved by The North American Menopause Society (NAMS) Board of Trustees on February 23, 2007.

Summary

• The primary goals of vaginal atrophy management are to relieve symptoms and reverse atrophic anatomic changes.
• First-line therapies for women with vaginal atrophy include nonhormonal vaginal lubricants and moisturizers.
• For symptomatic vaginal atrophy that does not respond to nonhormonal vaginal lubricants and moisturizers, prescription therapy may be required.
• Randomized controlled trials in postmenopausal women, albeit limited, have shown that low-dose, local, prescription vaginal estrogen delivery is effective and well tolerated for treating vaginal atrophy while limiting systemic absorption.
• All low-dose vaginal estrogen products approved in the United States for treating vaginal atrophy (estradiol vaginal cream, conjugated estrogens (CE) vaginal cream, the estradiol vaginal ring, and the estradiol hemihydrate vaginal tablet) are equally effective at the doses recommended in labeling. The choice is dependent on clinical experience and patient preference.
• Progestogen is generally not indicated when low-dose estrogen is administered locally for vaginal atrophy.
• If a woman is at high risk for endometrial cancer, is using a greater dose of vaginal estrogen therapy (ET), or is having symptoms (spotting, breakthrough bleeding), closer surveillance may be required. There are insufficient data to recommend annual endometrial surveillance in asymptomatic women using vaginal ET.
• Vaginal ET should be continued as long as distressful symptoms remain.
• For women treated for non-hormone-dependent cancer, management of vaginal atrophy is similar to that for women without a cancer history. For women with a history of hormone-dependent cancer, management recommendations are dependent upon each woman's preference in consultation with her oncologist.

None provided

The type of supporting evidence is not specifically stated for each recommendation.

The position statement was supported by evidence from randomized, controlled trials, meta-analyses, and review articles. If the evidence was contradictory or inadequate to form a conclusion, a consensus-based opinion was established.

Appropriate use of local vaginal estrogen therapy in the treatment and management of vaginal atrophy in postmenopausal women

• Adverse effects of local vaginal estrogen therapy (ET), including:
  • Vaginal bleeding and breast pain
  • Paresthesias and benign endometrial disorders
  • Candidiasis
  • Systemic absorption
  • Endometrial hyperplasia and adenocarcinoma
• If a woman is at high risk for endometrial cancer, is using a greater dose of vaginal ET, or is having symptoms (spotting, breakthrough bleeding), closer surveillance may be required.

Because standards of care and available treatment options differ throughout the world, the focus was limited to therapies available in North America.

An implementation strategy was not provided.

Getting Better
Staying Healthy

Effectiveness

Not applicable: The guideline was not adapted from another source.

2007 May

The North American Menopause Society - Private Nonprofit Organization

The development of this position statement was supported by an unrestricted educational grant from Novo Nordisk, Inc.

Editorial Board

Editorial Board Members:

Gloria A. Bachmann,MD (Chair), Associate Dean for Women`s Health, Professor of Obstetrics and Gynecology, and Professor of Medicine, University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, Director of Women`s Health Institute, Chief of OB/GYN Service, Robert Wood Johnson University Hospital, New Brunswick, NJ

Shawna L. Johnston, MD, Associate Professor, Departments of Obstetrics & Gynaecology and Urology, Chair, Division of Urogynaecology and Reconstructive Pelvic Surgery, Queen's University, Kingston, ON, Canada

Bruce Kessel, MD, Associate Professor, Department of Obstetrics and Gynecology, and Women's Health, John A. Burns School of Medicine, University of Hawaii, Honolulu, HI

M. Tish Knobf, PhD, RN, Associate Professor, Yale University School of Nursing, New Haven, CT

Elizabeth G. Stewart, MD, Assistant Professor of Obstetrics, Gynecology and Reproductive Biology, Harvard Medical School, Boston, MA, Director, Stewart-Forbes Vulvovaginal Service, Harvard Vanguard Medical Associates, Burlington, MA

The North American Menopause Society (NAMS) is committed to ensuring balance, independence, and objectivity in all its educational activities. All those involved in the development of a continuing medical education (CME) activity are required to disclose financial relationships they or their spouse/partner have had during the last 12 months with a commercial interest whose products or services are discussed in the CME activity content, or with any commercial supporters of the activity, over which they have control.

For the Editorial Board, Dr. Bachmann reports: Research support: Berlex, Duramed, Johnson & Johnson, Pfizer, Roche, Wyeth; Speaker: Johnson & Johnson, Wyeth. Dr. Johnston reports: Advisory board: Paladin Labs Canada; Speaker: Paladin Labs Canada, Wyeth Canada. Dr. Kessel reports: Research support: Procter & Gamble, Wyeth; Speaker: Berlex, Merck, Procter & Gamble, Wyeth. Dr. Knobf reports: No significant financial relationships. Dr. Stewart reports: No significant financial relationships.

The NAMS Board of Trustees reports the following list of all financial relationships, not just those related to this CME activity: Dr. Clarkson reports: Member: Council on Hormone Education; Speaker: Wyeth. Dr. Freedman reports: Consultant: Alexza, Duramed, GlaxoSmithKline, Novartis, Organon, Pfizer, Vela, Wyeth; Research Support: GlaxoSmithKline, National Institutes of Health, Organon. Dr. Gallagher reports: Consultant, Research support: Organon, Pfizer, Wyeth. Dr. Goldstein reports: Advisory board: Eli Lilly, GlaxoSmithKline, Merck, Pfizer, Procter & Gamble. Dr. Gorodeski reports: Director, Medical Advisory Board: CytoCore. Dr. Henderson reports: Consultant: Council on Hormone Education, Wyeth. Dr. Kagan reports: Advisory board: Merck; Consultant: Merck, Roche/GlaxoSmithKline; Research support: Amgen, Aventis, Eli Lilly, Novartis, Procter & Gamble, Roche/GlaxoSmithKline, Wyeth; Speaker: Merck, Roche/GlaxoSmithKline. Dr. Pinkerton reports: Consultant: Boehringer Ingelheim, Duramed, Merck, Council on Hormone Education; Member: National Women's Health Resource Center; Research support: Solvay, Wyeth; Speaker: Merck. Dr. Reame reports: Consultant: Cypress Bioscience, Procter & Gamble; Research support: Novo Nordisk, Procter & Gamble. Dr. Rothert reports: No significant financial relationships. Dr. Schiff reports: Advisory board: Pause, the consumer magazine of the American College of Obstetricians and Gynecologists; Editor-in-chief: Menopause, the official journal of The North American Menopause Society. Dr. Speroff reports: Consultant: Warner-Chilcott; Research support: Barr, Berlex, Organon, Wyeth. Dr. Stuenkel reports: No significant financial relationships. Dr. Utian reports: Advisory board: Consultant: Barr/Duramed, Berlex, Depomed, Endoceutics, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Organon, Pfizer, Roche/GlaxoSmithKline; Research support: Amylin, Barr, Berlex, Bristol Myers Squibb, Duramed, Eli Lilly, Forest, Galen, GlaxoSmithKline, Johnson & Johnson, Neurocrine, Novartis, Novo Nordisk, Organon, Pfizer, Pharmacia, Procter & Gamble, Roche, Sepracor, Solvay, 3M, Wyeth, Yamanouchi

For additional contributors, Ms. Boggs, Dr. Graham, and Ms. Wisch all report no significant financial relationships.

This is the current release of the guideline.

None available

This summary was completed by ECRI Institute on June 28, 2007. The information was verified by the guideline developer on July 13, 2007.

This summary is based on content contained in the original guideline, which is subject to terms as specified by the guideline developer. Users are free to download a copy of the materials and information on a single computer for personal, noncommercial use only; provided that any copyright, trademark or other proprietary notices are not removed from any materials and information downloaded. Any other use requires written permission from the guideline developer.