Treating Postmenopausal Vaginal Atrophy When Estrogen is Not an Option
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. Determine which postmenopausal patients are not appropriate candidates for estrogen 2. List other options available for mitigating or treating postmenopausal vaginal atrophy
Estimated time to complete activity: 0.25 hours
Susan J. Gross, MD, FRCSC, FACOG, FACMG
President and CEO, The ObG Project
Disclosure of Conflicts of Interest
Postgraduate Institute for Medicine (PIM) requires faculty, planners, and others in control of educational content to disclose all their financial relationships with ineligible companies. All identified conflicts of interest (COI) are thoroughly vetted and mitigated according to PIM policy. PIM is committed to providing its learners with high quality accredited continuing education activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of an ineligible company.
The PIM planners and others have nothing to disclose. The OBG Project planners and others have nothing to disclose.
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 31 2017 through Jan 25 2023, 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.
If a patient complains of dyspareunia, and clinical examination is consistent with postmenopausal vaginal atrophy / atrophic vaginitis, local estrogen is the first line of treatment, but there are alternatives that can be considered if the following two criteria are met:
Ascertain if the patient can, indeed, use estrogen and ensure that option was offered and an informed decision to decline was met
Screen for a history of breast or uterine cancer, history of blood clots or liver conditions
Some postmenopausal patients will not or cannot use local estrogen replacement therapy to treat vaginal atrophy/atrophic vaginitis. Common situations in which this is the case may include personal history of estrogen-sensitive breast cancer or endometrial cancer, although NAMS guidelines do recommend that low-dose local HT may be an option, in consultation with a patient’s oncologist in certain situations. Fortunately, a number of effective options are available for these women.
When a clinician cannot prescribe local estrogen, alternatives for postmenopausal vaginal atrophy include
Ospemifene – 60 mg daily
Should not be used concomitantly with estrogens
Should be used for 12 continuous weeks in order to gauge effectiveness
Ospemifene is a SERM
According to the FDA, there is insufficient data to use ospemifene in women with breast cancer
While there do not appear to be any cases of ospemifene causing endometrial cancer, a potential risk for this particular malignancy is mentioned in a boxed warning
Prasterone – One vaginal insert (6.5 mg) each evening at bedtime
FDA approved, steroid-based treatment for postmenopausal vaginal atrophy
Use is appropriate for women who complain of dyspareunia due to dryness and thinning of the vaginal mucosa
Based on the fact that there is minimal data on safety in the setting of hormonally sensitive malignancy, the FDA warns against using prasterone if there is a history of or known or suspected breast cancer
Have been found to be efficacious and may help alleviate symptoms
Laser Treatment – FDA Statement
The FDA has released a statement (August 2018) warning that “…safety and effectiveness of these devices hasn’t been evaluated or confirmed by the FDA for “vaginal rejuvenation.” In addition to the deceptive health claims being made with respect to these uses, the “vaginal rejuvenation” procedures have serious risks.”
ACOG supports the FDA statement and has a position statement advising that while there is there is FDA clearance of fractional C02 laser, indications do not specify treatment of vulvovaginal atrophy, but do include
incision, excision, ablation, vaporization, and coagulation of body soft tissues in medical specialties, including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery
NAMS has also responded and while welcoming the FDA’s mandate requiring companies to provide adequate data, the NAMS statement includes the following to assist with counseling
NAMS recommends that healthcare providers discuss the benefits and risks of all available treatment options for vaginal symptoms, including over-the-counter lubricants, vaginal moisturizers, and FDA-approved vaginal therapies such as vaginal estrogen and
intravaginal dehydroepiandrosterone and oral therapies such as hormone therapy and ospemifene to determine the best treatment for women with GSM. When discussing vaginal energy-based therapies, informed discussion should include that these are FDA-approved devices for gynecology but have not received FDA approval for vaginal rejuvenation or procedures for GSM, sexual function, incontinence, or pelvic laxity and that even though short-term data are promising, more robust, sham-controlled, and longer-term data are needed.
While alternative treatments will address vaginal dryness and atrophy, patients should be informed of the limitations of these treatments
Treatments that are effective for managing vaginal atrophy, may not help with other menopausal symptoms such as hot flashes, night sweats or mood
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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.
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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