Guidelines 2016 – Hormone Therapy

Guidelines for Nurse Practitioners in Gynecologic Settings 2016
Care Plan – Hormone Therapy
Z79.890: Hormone replacement therapy

I. DEFINITION
Ht is the use of exogenous natural or synthetic estrogen or estrogen and progestin in combination by the postmenopausal woman (whether natural or surgical menopause has occurred) to alleviate the symptoms of lower amounts of natural estrogen.

II. ETIOLOGY
a. the theca interna and granulosa cells of the ovarian follicles and the corpus luteum produce three naturally occurring estrogens (estra- diol, estrone, and estriol) together with precursors, luteinizing hor- mone (LH), and FsH from the anterior pituitary and androstenedione from the adrenals. the corpus luteum and ovarian follicle produce progesterone. the stromal tissues of the ovaries produce insignificant amounts of androgens; the major sources of androgens in women are

the adrenals. during the perimenopausal years, there is a gradual decrease of the production of these hormones.

III. HISTORY
a. What the patient may present with
1. irregular menstrual cycles: longer than 35 days, shorter than 21 days
2. Changes in character of cycles: scanty, brief duration, begin with flooding, clots, dysmenorrhea
3. sleep disturbances, night sweats
4. experiencing hot flashes and hot flushes
5. dyspareunia
6. Changes in vaginal tissue: dryness, itching, burning of vulva
7. urinary urgency or frequency, urethral pain, irritation at meatus
8. no vaginal bleeding for prior 12 months or more
9. surgical menopause: hysterectomy with bilateral oophorectomy and salpingectomy
B. additional information to be considered
1. age of patient and of her biological mother at menopause
2. Last Pap smear, breast self-examination, mammogram, bone den- sity testing
3. medical, surgical, and gynecologic/obstetric history; history of pelvic surgery
4. Family medical history, especially osteoporosis, heart disease, car- cinoma, alzheimer’s disease
5. signs, symptoms of possible vaginitis, vaginosis, sti, cystitis
6. Lifestyle: diet, exercise, smoking, alcohol
7. Change in mood or sense of well-being
8. all medications, including otC, herbals, homeopathics

IV. PHYSICAL EXAMINATION
a. Vital signs
B. Complete age-appropriate physical examination per aCoG annual Women Healthcare guidelines
C. Pelvic examination
1. Vulva and perineum, noting any signs of infection, atrophy, irrita- tion; hair distribution and signs of thinning; loss of adipose tissue
2. Vagina: color, rugae, signs of atrophy, infection or irritation, length
3. Cervix: color, any lesions, ectropion
4. urethral os: signs of irritation, atrophy, urethrocele
5. Pelvic floor integrity: cystocele, rectocele, uterine prolapse
6. uterus: size, shape, position, contour, mobility, presence of masses, tenderness
7. adnexa: masses, tenderness
8. rectal examination: masses, rectocele, uterine anomalies, occult blood

V. LABORATORY EXAMINATION
a. Pap smear according to asCCP guidelines
B. mammogram
C. may consider endometrial biopsy with intact uterus
d. Vaginal and/or urine cultures: HiV, sti screen as appropriate
e. serum FsH or testosterone assay as indicated
F. Lipid profiles, thyroid function test, serum glucose
G. Hematocrit or hemoglobin as indicated
H. Bone density assays if indicated
i. Pelvic/transvaginal ultrasound if pelvic examination is positive for masses
J. Per findings of physical examination and from history

VI. CONSIDERING HORMONE THERAPY
a. Contraindications
1. undiagnosed vaginal bleeding
2. Known or suspected pregnancy
3. History of nontraumatic pulmonary embolism (Pe) or deep vein thrombosis (dVt)
4. Known or suspected cancer of the breast or reproductive tract (estrogen-dependent carcinomas); malignant melanoma at any stage
5. Currently on anticoagulants or tamoxifen
B. Precautions: consider clinical data, risk, and benefits
1. active gallbladder disease
2. Family history of breast cancer
3. migraine headaches
4. elevated triglycerides, high low-density lipoprotein (LdL), low high-density lipoprotein (HdL)
5. Leiomyomata
C. Weighing risks and benefits
1. osteoporosis in family or personal history; risk factors for osteoporosis (see osteoporosis handout in Appendix I)
2. Personal and family medical history, including heart and alzheimer’s disease; breast cancer; ovarian, endometrial, colon cancer
3. Presence of indicators for benefits in absence of absolute contrain- dications and weighing of relative risks
4. Consideration of risks with smoking, hypertension, epilepsy, migraines, benign breast or uterine disease, endometriosis
5. Consideration of benefits to genitourinary tract, feelings of well-being
6. the use of Ht remains a highly individualized decision, and controversial issues remain.
7. access to health care for follow-up: endometrial biopsy, mammog- raphy, monitoring for side effects, danger signs

8. alternatives to Ht: diet, exercise, calcium from exogenous source in addition to foods, botanicals, vitamins, nonhormonal vaginal lubricants (such as astroglide), naturalistic interventions, homeo- pathic preparations (see General Care Measures section, this chapter, and Complementary and Alternative Therapies, Chapter 3)
9. recommendation currently for Ht is for lowest effective dose for shortest amount of time.

VII. HORMONE REGIMENS
a. absence of uterus: estrogen only or estrogen and androgen
1. may be synthetic or compounded bioidentical
2. types of preparations
a. oral
b. transdermal
i. Patch
ii. Gel/spray/cream
c. Vaginal
i. ring
ii. tablet
iii. Cream
B. Presence of uterus: add progestin
1. types of preparation
a. oral
b. transdermal (compounded cream)
c. Progesterone intrauterine device (iud)
2. regimes
a. sequential
b. Continuous
C. other
1. raloxifene hydrochloride (evista) synthetic selective estrogen receptor modulator 60 mg orally daily. use daily for osteoporosis protection.
2. Custom compounded Ht, oral, topical, and pellet implant (estro- gen, progesterone, and testosterone) may be compounded by many pharmacists and mail order pharmacies specializing in natural hormones.
a. referral to compounding pharmacists atwww.iacprx.org (international academy of Compounding Pharmacists)
3. Brisdelle (paroxetine) capsules, 7.5 mg per capsule. approved by the u.s. Food and drug administration (Fda), nonhormonal, proven effective therapy for moderate-to-severe vasomotor symp- toms (Vmss) associated with menopause.
4. osphena (ospemifene) is an estrogen agonist/antagonist with tissue-selective effects and is given as 60 mg orally daily for treat- ing dyspareunia associated with postmenopausal vulvar and vaginal atrophy.

d. Withdrawal bleeding
1. Will occur with sequential use of progestin
2. no bleeding should occur with continuous use.

VIII. CLINICAL MANAGEMENT
a. side effects
1. Bleeding with hormone use
a. With sequential use
b. With continuous use
i. Consider change in dosage or medication
ii. if not effective, do endometrial biopsy
c. unopposed estrogen use (still prescribed by some providers)
i. encourage combination therapy; prior to changing therapy, consider using a progestin. if no bleeding, begin new regi- men. if bleeding does occur, do endometrial biopsy or do an ultrasound to measure lining.
2. Breast tenderness
3. Fluid retention
4. Weight gain (increased appetite)
5. dysmenorrhea with withdrawal bleeding
6. depression
7. irritability or emotional lability
8. Possible increase in size of uterine leiomyomata
9. allergic response to patch
10. Virilization with androgens (rare)
B. other clinical management strategies
1. topical estrogen for vaginal dryness
2. alternative nonhormonal vaginal lubricants such as astroglide, replens, or Luvena
3. Complementary/alternative modalities to be considered, including many botanicals as well as acupuncture, massage, and relaxation; can increase a woman’s feeling of well-being
4. Careful teaching about modalities used
C. Follow-up and lifestyle on Ht
1. reinforce need for calcium intake from both food and supple- mentary sources; will also need a consistent source of vita- min d plus magnesium in appropriate dose for adequate absorption
2. regular program of exercise, strength training
3. reinforce knowledge of risks and benefits
4. Preventive health care: well-woman examination, Pap smear as indicated by asCCP guidelines, mammography, breast, and vul- var self-examination
5. Consider periodic monitoring for bone density, lipid profile

6. Vaginal lubricants, signs of vaginal infection or cystitis versus dry- ness, Kegel exercises, sexuality
7. Careful use of herbals, vitamins, and isoflavones with Ht
See Appendix I and Bibliographies.