CC#6: Compounded Bioidentical Menopausal Hormone Therapy

Question 1

What are bioidentical hormones?

Answer 1

Plant-derived hormones that are chemically similar or structurally identical to those produced by the body

Question 2

FDA-approved bioidentical products (3)

Answer 2

Micronized progesterone, estradiol, DHEA

Question 3

Compounded preparations not regulated by the FDA (7)

Answer 3

Estrone, estradiol cypionate, estriol, pregnenolone, testosterone, testosterone cypionate, testosterone propionate

Question 4

What is “bioidentical hormone” primarily used as by compounding pharmacies?

Answer 4

A marketing term

Question 5

Available routes of administration of compounded bioidenticals (6)

Answer 5

PO, sublingual, percutaneous, implants, injectable, suppositories

Question 6

Situations in which bioidential compounding is considered appropriate (2)

Answer 6

For pts when the exact products needed are not commercially available, when different ingredients/ preservatives/routes of admin are required 2/2 pt intolerance/allergy or needs (ie inability to swallow a PO pill)

Question 7

What federal act do compounding pharmacies fall under that allows them to bypass FDA review for safety/effectiveness/quality?

Answer 7

Section 503A of the Federal Food Drug and Cosmetic Act

Question 8

Safety issues w/ custom-compounded hormone therapy (4)

Answer 8

Significant variability in mixtures of hormones included, high variability in amount of active med within a specific dose (2/2 lack of regulation), no requirements for adverse event reporting, potential for bacterial contamination

Question 9

FDA-approved testosterone formulation for cisgender female pts

Answer 9

None currently

Question 10

Pts in whom short-term transdermal testosterone can be considered as a tx option

Answer 10

Postmenopausal pts w/ sexual interest/arousal disorders (who have been appropriately counseled about risks and unknown long-term effects)

Question 11

Most commonly reported adverse events seen w/ testosterone therapy in cisgender female pts (3)

Answer 11

Hirsutism, acne, virilization (which may be irreversible)

Question 12

Advantages of testosterone pellet therapy over IM injections or patches (2)

Answer 12

Better bioavailability, more predictable absorption

Question 13

Disadvantages of testosterone pellet therapy over PO/topical products (2)

Answer 13

Pellet cannot be removed but rather dissolves over time, potentially exposes user to testosterone over longer period of time

Question 14

General situations in which individualized testing is useful (3)?

Answer 14

When there is a narrow therapeutic window for a drug/class of drugs, when serum hormone levels can be reliably assessed, if results would change management

Question 15

Kinds of drugs that warrant individualized testing (4)

Answer 15

Meds w/ nonlinear pharmacokinetics, meds that are eliminated by kidney as active drug, meds that are not metabolized by liver through first-pass metabolism, meds that have clearly defined therapeutic/toxic windows based on data from large population pharmacokinetic studies

Question 16

Percentage of steroid hormones circulating in free form (not bound to albumin)

Answer 16

<5%

Question 17

General levels of estrogen seen in saliva

Answer 17

Extremely low

Question 18

Are there any FDA-approved salivary/urinary tests for steroid hormone measurement?

Answer 18

Not currently

Question 19

Target estradiol level (to provide reasonable relief from sxs) for pts already having started compounded bioidentical menopausal HRT, in order to titrate dosing

Answer 19

40-100pg/mL

Question 20

Next step in surveillance in pts who are already currently using pellet therapy

Answer 20

Testing to r/o supraphysiologic testosterone levels

Question 21

Recommended range of testosterone in pts on menopausal testosterone therapy

Answer 21

20-80mg/dL (physiologic premenopausal range)

Question 22

Characteristics that may be variable in bioidentical hormones (4)

Answer 22

Absorption, potency, purity, quality

Question 23

Advantages of FDA-approved patches over PO hormones (3)

Answer 23

More consistent delivery, relatively steady level of estradiol, lower risk of VTE

Question 24

Sxs for which FDA-approved DHEA is available?

Answer 24

Vaginal sxs

Question 25

Poss routes of estradiol that are FDA-approved (4)

Answer 25

PO tabs, transdermal patches, transdermal gels/ emulsions/sprays, vaginal ring

Question 26

FDA-approved doses of PO estradiol tabs (3)

Answer 26

0.5mg, 1.0mg, 2.0mg

Question 27

FDA-approved doses of transdermal patches (6)

Answer 27

14mcg, 25mcg, 37.5mcg, 50mcg, 75mcg, 100mcg

Question 28

For how many days does the vaginal ring provide systemic levels of estradiol?

Answer 28

90 days

Question 29

Poss routes of progesterone that are FDA-approved (3)

Answer 29

PO, vaginal gel (not FDA-approved for tx of menopausal sxs), vaginal insert (not FDA-approved for tx of menopausal sxs)

Question 30

FDA-approved doses of PO micronized progesterone (2)

Answer 30

100mg, 200mg

Question 31

Available concentrations of vaginal progesterone gel (2)

Answer 31

4%, 8%

Question 32

Available dose of vaginal progesterone insert

Answer 32

100mg

Question 33

Dosing of FDA-approved combination estradiol-progesterone therapy

Answer 33

PO estradiol 1mg + micronized progesterone 100mg

Question 34

Route of testosterone delivery most recommended

Answer 34

Gel

Question 35

Med, and route of delivery, of FDA-approved DHEA

Answer 35

Prasterone, vaginal insert

Question 36

Should OBGYNs sell/promote agents/devices as being therapeutic?

Answer 36

No, not w/o adequate evidence of medical benefit