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Sexual Health
CMECNE

Local Estrogen Treatment Options for Vaginal Atrophy

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Learning Objectives and CME/Disclosure Information

This activity is intended for healthcare providers delivering care to women and their families.

After completing this activity, the participant should be better able to:

1. Discuss the role of estrogen in the treatment of peri- and postmenopausal vaginal atrophy
2. List the various formulations that are currently available for women who opt for estrogen therapy for vaginal atrophy

Estimated time to complete activity: 0.25 hours

Faculty:

Susan J. Gross, MD, FRCSC, FACOG, FACMG
President and CEO, The ObG Project

Disclosure of Conflicts of Interest

Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

Faculty: Susan J. Gross, MD, receives consulting fees from Cradle Genomics, and has financial interest in The ObG Project, Inc.

Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.

Method of Participation and Request for Credit

Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from Dec 3 2018 through Dec 3 2021, participants must read the learning objectives and faculty disclosures and study the educational activity.

If you wish to receive acknowledgment for completing this activity, please complete the post-test and evaluation. Upon registering and successfully completing the post-test with a score of 100% and the activity evaluation, your certificate will be made available immediately.

For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.

Joint Accreditation Statement

In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Physician Continuing Medical Education

Postgraduate Institute for Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Continuing Nursing Education

The maximum number of hours awarded for this Continuing Nursing Education activity is 0.2 contact hours.

Designated for 0.1 contact hours of pharmacotherapy credit for Advance Practice Registered Nurses.

Read Disclaimer & Fine Print

CLINICAL ACTIONS:

A growing number of estrogen treatment options are available for postmenopausal vaginal atrophy. Vulvovaginal atrophy is a common symptom of atrophic vaginitis (also referred to as the genitourinary syndrome of menopause or GSM) and can occur in both perimenopausal and postmenopausal women. If a patient reports vaginal dryness, consider the following

  • Establish a diagnosis of postmenopausal atrophy based on thorough history and physical exam
    • Confirm with an appropriate pelvic/ vaginal exam
  • Discuss use of estrogen, understanding that for some women based on medical history, systemic estrogen might not be an appropriate option
    • Even with a personal history of cancer, local estrogen may be an appropriate treatment (see ‘Key Points’ and ‘Related ObG Topics’ below) depending on the clinical scenario
  • Vaginal estrogens can be prescribed as
    • A cream inserted twice weekly using an applicator
    • A tablet inserted with an applicator
    • A soft gel pellet inserted twice weekly with no applicator (FDA approved May, 2018)
    • Ring made of silicone elastomere containing a drug core of estradiol hemihydrate (replaced every 3 months)

Local Estrogen Routes and Dosing for GSM

  • Estradiol-17β ring (releases 7.5 micrograms/d)
    • Replace every 3 months
  • Estradiol vaginal tablet (10 micrograms/d)
    • Place nightly for 2 weeks
    • Maintenance is one tablet 2 times/week
    • Note: this is the corrected dose in ACOG PB 141
  • Estradiol-17β cream (0.1 mg active ingredient/g)
    • 2-4 g/d for 1 to 2 weeks
    • Gradually reduce to ½ initial dosage for 1 – 2 weeks
    • Maintenance is 1 g, 1 to 3 times/week
  • Conjugated estrogen cream (0.625 mg/g)
    • 0.5–2 g/d for 21 days then off for 7 days
    • In practice during maintenance therapy, most women apply 1 – 3 times /week
  • Vaginal inserts (4-μg and 10-μg)
    • 1 vaginal insert daily for 2 weeks
    • Maintenance is 1 insert twice weekly

SYNOPSIS:

Patients may experience vaginal atrophy as itching, dryness or pain during sexual activity. Vaginal estrogen has been shown to improve moderate to severe menopausal vaginal atrophy. Options for topical estrogen treatment are increasing. Women’s healthcare professionals need to confirm appropriate use of estrogen and help patients identify which treatment option will work best for their situation and lifestyle.

KEY POINTS:

  • During perimenopause and menopause, estrogen levels decline in vaginal tissues
    • Referred to as vulvovaginal atrophy (VVA), this may result in discomfort or pain during intercourse or general dryness and discomfort
  • If patient complains of dyspareunia, and clinical examination is consistent with postmenopausal vaginal atrophy / atrophic vaginitis, local estrogen is the first line and most effective treatment
    • Estrogen treatment may not be appropriate or desired by all patients
  • Ascertain if estrogen is an appropriate option for the patient
    • Screen for a history of breast or uterine cancer
    • History of blood clots
    • Liver conditions
  • If patient is appropriate for treatment with local estrogen, offering the spectrum of choices can help a patient identify the product that will work best for them
  • While there is a theoretical concern regarding systemic estrogen absorption and risk for uterine cancer, based on evidence, professional organizations  consider “the addition of progestin for endometrial protection is not needed” (ACOG)

Differentiating factors include

  • Creams
    • Can be used on the vulva as well as internally in the vagina
  • Tablets or caplets
    • Some can be used during the day
    • Some tablets may need to be used at night because of the way they dissolve
  • Applicators
    • May be an issue of patient preference and warrants discussion
  • Ring
    • Benefits include ease of use
    • For some women, there may be structural issues related to comfort and/or retention  (e.g., short or narrow vagina / prolapse)
  • Make patients aware that there are non-estrogen options available for use by women who are not appropriate candidates for local estrogen including
    • Prasterone | Ospemifene
  • Laser Treatments have been advocated as a possible treatment, however VVA not a currently FDA-approved indication

Learn More – Primary Sources:

The 2017 hormone therapy position statement of The North American Menopause Society

Scientific Background Report for the 2017 Hormone Therapy Position Statement of The North American Menopause Society

ACOG Practice Bulletin 141: Management of Menopausal Symptoms

Practice Bulletin 141: Management of Menopausal Symptoms: Correction

A Randomized, Multicenter, Double-Blind, Study to Evaluate the Safety and Efficacy of Estradiol Vaginal Cream 0.003% in Postmenopausal Women with Vaginal Dryness as the Most Bothersome Symptom.

FDA Highlights of Prescribing Information for IMVEXXY

Drugs@FDA: Estring

Drugs@FDA: Estrace Cream

Drugs@FDA: Premarin Vaginal Cream 

Drugs@FDA: Vagifem Tablet 

Estradiol vaginal inserts (4 µg and 10 µg) for treating moderate to severe vulvar and vaginal atrophy: a review of phase 3 safety, efficacy and pharmacokinetic data

Reviewing the options for local estrogen treatment of vaginal atrophy

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Related ObG Topics:

North American Menopause Society: Hormone Therapy Statement
Genitourinary Syndrome of Menopause: New Name, Old Problem
Prasterone for Vulvovaginal Atrophy – What is it and How to Prescribe
Treating Postmenopausal Vaginal Atrophy When Estrogen is Not an Option
Prescribing Ospemifene for Postmenopausal Vaginal Atrophy

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OBG Project CME requires a modern web browser (Internet Explorer 10+, Mozilla Firefox, Apple Safari, Google Chrome, Microsoft Edge). Certain educational activities may require additional software to view multimedia, presentation, or printable versions of their content. These activities will be marked as such and will provide links to the required software. That software may be: Adobe Flash, Apple QuickTime, Adobe Acrobat, Microsoft PowerPoint, Windows Media Player, or Real Networks Real One Player.

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

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