Endocrinology - 03 (1) - Contraception and Hormone Therapy (Courses in Therapeutics and Disease State Management)

Endocrinology: Contraception
and Hormone Therapy in

Women
Courses in Therapeutics and Disease State Management
Author: Autumn Stewart, PharmD, BCACP, CTTS; Associate Professor of Pharmacy Practice; Duquesne University School of Pharmacy
http://accesspharmacy.mhmedical.com/LearningModuleGroup.aspx?id=8
Copyright © 2017 McGraw-Hill Education. All rights reserved
Contraception: Introduction
• Six million pregnancies in the U.S. annually
• Estimated that 37-45% of pregnancies are unintended
• Approximately half of unintended pregnancies end in abortion
• 40% occur in those who claim the use of contraception
• Contraception is the prevention of pregnancy following sexual
intercourse
• inhibit sperm from contact with a mature ovum
• preventing a fertilized ovum from implantation
• Understanding of the hormonal regulation of the menstrual cycle is
key to understanding contraception.
• Link: Figure outlining Menstrual cycle events, idealized 28-day cycle.
Considerations When Selecting a
Contraceptive Method
• Efficacy
• Link:
Table on Pregnancy and Continuation Rates for Various Pharmacologic Contraceptive Metho
ds
• Safety
• Link: Table on Compax`rison of Methods of Nonhormonal Contraception
• Contraindications
• Adverse effects
• Non-contraceptive benefits
• Protection from sexually transmitted disease
• Restoration of menstrual cycle
• Reduced menstrual flow/cessation of menses
• Improvement of acne, PCOS, PMS/PMDD, etc
• Patient preferences
• Ease of use, cost, convenience, reversibility
Expanded Role of the Pharmacist
• Pharmacists in several states have ability to initiate contraceptive
therapy
• May recommend an oral contraceptive as part of the management or
treatment of a disease state
• Counsel patients prescribed oral contraceptive therapy
• Managing adverse effects that arise from therapy
Combined Hormonal Contraceptives
• Contain an estrogen and a progestin
• Available as oral tablets (aka combined oral contraceptive, COCs), a
patch, and a vaginal ring
• Progestin prevents the LH surge, inhibiting ovulation
• Estrogen blocks FSH, preventing ovulation and stabilizes the
endometrial lining to control cyclical bleeding
• Link:
Table on Composition of Commonly Prescribed Oral Contraceptives
Contraindications
• Link:
Table on Medical Eligibility Criteria for Contraceptive Use: Classifica
tions for Combined Hormonal Contraceptives
• Switching to a non-estrogen containing contraceptive may be needed
Managing Adverse Effects (Slide 1 of 2)
• Link:
Table on Symptoms of a Serious or Potentially Serious Nature of Com
bined Hormonal Contraception
• Link: Table on Monitoring Patients Taking Hormonal Contraceptives
Managing Adverse Effects (Slide 2 of 2)
• Too much estrogen
• Nausea, breast tenderness, increased blood pressure, melasma, headache
• Too little estrogen
• Early or mid-cycle breakthrough bleeding, increased spotting, hypomenorrhea
• Too much progestin
• Breast tenderness, headache, fatigue, changes in mood
• Too little progestin
• Late breakthrough bleeding
• Too much androgen
• Increased appetite, weight gain, acne, oily skin, hirsutism, lipids
• Unscheduled/Breakthrough Bleeding (BTB)
• Normal during first 3 months-does not warrant a change in therapy
• Drug interactions? Smoking?
• Early in cycle warrants increase in estrogen dose
• BTB later in cycle usually requires hgher progestin amounts
Managing Drug Interactions (Slide 2 of 2)
• Drugs that interfere with GI absorption, increase intestinal motility by
altering gut flora, or induce the metabolism of estradiol have the
potential to interact with CHCs
• Link:
Table of partial list of drugs that enhance drug metabolism in humans
• Link: Figure of enterohepatic recirculation of bile acids and drug
COCs (Slide 1 of 3)
• When to Start
• “First Day Start”
• Initiate OC on the first day of the next menstrual cycle
• “Sunday Start”
• Initiate OC on the first Sunday after the menstrual cycle
• “Quick Start”
• Initiate OC on the day prescription is received
• Post-partum
• 42 days for women at increased risk of VTE
• 4 weeks if breastfeeding
• 21 days for all other women
• Link:
Table on Medical Eligibility Criteria for Contraceptive Use: Classifications for Combined Hor
monal Contraceptives
COCs (Slide 2 of 3)
• Regimens
• Traditional
• 21-7 or 28 day regimen-21 days active and 7 day hormone free interval
• Extended cycle
• 84-7 regimen -84 days active and 7 days hormone free (or 7 days with estrogen)
• 24-4 regimen-24 days active and 4 days hormone free
• Continuous
• 365 days active and NO hormone free interval
• Link: Table on Composition of Commonly Prescribed Oral Contraceptives
COCs (Slide 3 of 3)
• Missed Pills (from
U.S. Selected Practice Recommendations for Contraceptive Use, 2013
(US SPR)
. Source: MMWR. 2013;62(No. RR-5):1-60.)
• 7 days of uninterrupted therapy confers protection from pregnancy
• Hormone free intervals > 7 days may reduce efficacy
• Link:
Algorithm on Recommended Actions After Late or Missed Combined
Oral Contraceptives
Patch
• Ortho Evra®
• Ethinyl Estradiol 35 mcg/day + Norelgestromin (active form of norgestimate)
0.2 mg/day
• Women apply a new patch every week for 3 weeks followed by a
patch-free 4th week
• Efficacy may be reduced in women >90kg
• Counsel on the use of a backup method if patch is off for >24 hours
Vaginal Ring
• Nuvaring® Ethinyl Estradiol 15 mcg/day + Etonogestrel (active form
of desogestrel) 0.12 mg/day
• Inserted and left in place for 3 weeks and then removed for 1 week
• Use a backup method if out for >3 hours
Progestin Only Contraceptives
• Contain progestin alone
• Avoids thrombogenic effects of estrogen
• Avoids drug interactions
• Available as pills (POPs), Injectable, Implants and Intrauterine
systems
• Non-contraceptive benefits
• May result in amenorrhea
Progestin Only Pills (POPs)
• May have higher rates of irregular menses and breakthrough bleeding
• Link:
Table on Composition of Commonly Prescribed Oral Contraceptives
Injectable
• Depo-Provera® Depot medroxyprogesterone acetate every 3 months
• Ideal for women desiring contraception > 1 year
• Option for women with compliance issues to daily methods
• Long term use = bone loss
• Menstrual irregularities during the first year of use
Implants
• Long-acting reversible contraception
• Nexplanon®
• 4-cm-long implant, containing etonogestrel inserted under the skin of the
upper arm
• Provides 3 years of continuous protection
• Highly effective
Intrauterine systems
• Long-acting reversible contraception
• Levonorgestrel 20mcg (Mirena®) per day up to 5 years
• Also approved for treatment of heavy menses
• Levonorgestrel 9-17.5mcg (Kyleena®) per day up to 5 years
• Levonorgestrel 14mcg (Skyla®) per day up to 3 years
• Levonorgestrel 15.6mcg (Liletta®) per day up to 3 years
• Highly effective
Menopause
• Permanent cessation of menses due to permanent loss of ovarian
function
• Cessation of menses for 12 consecutive months
• Median age in U.S. is 52 years
• Physiologic symptoms may be present up to 4 years prior
(perimenopause)
Menopause Symptoms
• Symptoms related to lack of estrogen
• Vasomotor symptoms
• Hot flashes
• Night sweats
• Genitourinary changes
• Vulvovaginal atrophy
• Dryness
• Dyspareunia
• Incontinence
Menopause Goals of Therapy
• Reduce or eliminate symptoms to improve quality of life.
• Minimize risk of adverse effects from drug therapy.
• Highly individualized based on past medical history and clinical
presentation
Treatment
• Non-Pharmacologic
• Complementary and Alternative Medicine
• Hormone Replacement Therapy
• Miscellaneous agents
Non-Pharmacologic
Vasomotor Symptoms Genitourinary Changes
• Maintain cool environment • Personal lubricants
• Measures to aid in heat
dissipation
• Avoid Caffeine, Alcohol, Spicy
Foods
• Smoking Cessation
• Relaxation Therapy
Complementary and Alternative Medicine
• Black Cohosh
• Phytoestrogens
• Soy
• Red Clover
Hormone Replacement Therapy
• General Principles
• For Women with an intact uterus: Use Estrogen + Progesterone
• For Women without a uterus (s/p hysterectomy: Use Estrogen Alone
• Use systemic products in women with vasomotor symptoms +/- vaginal atrophy
• Use local products in women with vaginal atrophy only.
• Use lowest effective dose for the shortest duration possible.
• Estrogen Contraindications
• Hormone dependent cancer, DVT or PE, CVA or MI in last 12 months, active liver/gall
bladder disease
• Link:
Table on FDA-Labeled Indications and Contraindications for Menopausal Hormone T
herapy with Estrogens and Progestins
• Link:
Table on Summary of North American Menopause Society Position Statement on Me
nopausal Hormone Therapy
• Link: Algorithm for pharmacologic management of menopausal symptoms.
http://accesspharmacy.mhmedical.com/LearningModuleGroup.aspx?id=8 Selected Estrogen Only Containing Products

http://accesspharmacy.mhmedical.com/LearningModuleGroup.aspx?id=8 Selected Progestin Only Containing Products

http://accesspharmacy.mhmedical.com/LearningModuleGroup.aspx?id=8 Selected Estrogen Progestin Combination Products

Regimens
• Continuous-Cyclic (sequential)
• Estrogen is administered continuously (daily) with a progestin co-administered for at least 12 to 14 days
of a 28-day cycle
• Scheduled, predictable, withdrawal bleeding occurs 1 to 2 days after the last progestin dose.
• Continuous-Combined
• Estrogen and progestin are co-administered daily
• Eventually causes amenorrhea, but can cause unpredictable bleeding for first 6-12 months
• Continuous Long Cycle (cyclic withdrawal)
• Estrogen is given daily, and progestin is given six times a year, every other month for 12 to 14 days,
resulting in six periods a year
• Bleeding episodes may be heavier and last for more days than withdrawal bleeding with continuous-
cyclic regimens
• Intermittent Combined (continuous pulsed)
• Estrogen is given alone for 3 days followed by 3 days of combined estrogen and progestin, which is then
repeated without interruption
• Less bleeding, fewer progestin side effects
• Link: Table on Progestogen Dosing for Endometrial Protection (Cyclic Administration)
Miscellaneous Agents
• Selective Estrogen Receptor Modulators
• Ospemifene (Osphena®)
• Estrogen agonist in vaginal mucosa
• FDA-approved for dyspareunia from menopausal VVA
• Recommended by NAMS as second-line therapy
• 60mg once daily with food
• Currently requires added progestin in women with uterus
• Bazedoxifene/Conjugated estrogens (Duavee®)
• Endometrial estrogen antagonist/estrogen
• FDA-approved for moderate-severe vasomotor symptoms in women with a uterus (and
osteoporosis prevention)
• 20mg/0.45mg daily without regard to meals
Alternatives to Estrogen for Treatment of Hot
Flushes
Progestogen Brand Name Dosage
Dydrogesteronea Duphaston 10-20 mg/day for 12-14 days per
calendar month (oral dosage form
available as 10 mg tablets)
Medroxyprogesterone acetate Provera 5-10 mg/day for 12-14 days per calendar
month (oral dosage form available as 2.5,
5, 10 mg tablets)
Micronized progesterone Prometrium 200 mg/day for 12-14 days per calendar
month (oral dosage form available as 100
and 200 mg tablets)
Norethindrone acetate Aygestinb 5 mg/day for 12-14 days per calendar
month (oral dosage form available as 2.5,
5 mg tablets)
Management of Patients Taking Hormone Therapy Regimens
Initiation of Hormone Therapy
Hormone therapy should be used only as long as vasomotor symptom control is necessary (usually 2-3 years)
6-Week Follow-up Visit
•To discuss patient concerns about hormone therapy
•To evaluate the patient for symptom relief, adverse effects, and patterns of withdrawal bleeding (if continuous sequential hormone therapy is given)
Drug Adverse Drug Reaction Monitoring Parameter Suggested Change
Estrogen Persistence of hot flushes Increase estrogen dose
Estrogen Breast tenderness Reduce estrogen dose; switch to a
transdermal regimen
Progestogen Bloating Switch to another progestogen
Premenstrual-like symptoms
Annual Follow-up Visit
Annual monitoring: medical history, physical examination (including pelvic examination), blood pressure measurement, and routine endometrial cancer surveillance (as
indicated). Additional follow-up is determined based on the patient’s initial response to therapy and the need for any modification of the regimen
Breast examinations: annual mammograms (scheduled based on patient’s age and risk factors)
Osteoporosis prevention: BMD should be measured in women 65 years and older and in women younger than 65 years with risk factors for osteoporosis. Repeat testing
should be performed as clinically indicated.
In women taking sequential hormone Transvaginal ultrasound, and where indicated an endometrial biopsy should be performed if vaginal bleeding occurs at any time
therapy other than the expected time of withdrawal bleeding or when heavier or more prolonged withdrawal bleeding occurs (if
endometrial pathology cannot be excluded by endovaginal ultrasonography, further evaluation may be required, such as
hysteroscopy)
In women taking continuous combined Endometrial evaluation should be considered when irregular bleeding persists for more than 6 months after initiating therapy
hormone therapy
References (Slide 1 of 2)
• Shrader SP, Ragucci KR. Contraception. In: DiPiro JT, Talbert RL, Yee GC,
Matzke GR, Wells BG, Posey L. eds. Pharmacotherapy: A Pathophysiologic
Approach, 10e New York, NY: McGraw-Hill
• Kalantaridou SN, Borgelt LM, Dang DK, Calis K. Hormone Therapy in
Women. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey
L. eds. Pharmacotherapy: A Pathophysiologic Approach, 10e New York, NY:
McGraw-Hill
• Correia M. Drug Biotransformation. In: Katzung BG. eds. Basic & Clinical
Pharmacology, 14e New York, NY: McGraw-Hill
• Intended and unintended births in the United States: 1982–2010. National Health
Statistics Reports, No. 55. Hyattsville, MD: National Center for Health Statistics;
2012
• N Engl J Med. 2016 Mar 3;374(9):843-52.
References (Slide 2 of 2)
• Sun H, Zhao H. Drug Elimination and Hepatic Clearance. In: Shargel
L, Yu AC. eds. Applied Biopharmaceutics & Pharmacokinetics,
7e New York, NY: McGraw-Hill
• https://www.cdc.gov/reproductivehealth/contraception/mmwr/spr/
combined.html

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