Ovarian Hormone Replacement. Maria Wolfs MD MHSc FRCPC Assistant Professor University of Toronto Endocrinology St. Michael s Hospital

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1 Ovarian Hormone Replacement Maria Wolfs MD MHSc FRCPC Assistant Professor University of Toronto Endocrinology St. Michael s Hospital

2 Disclosures None to declare

3 Outline Hormones and the Menstrual cycle Ovarian hormone replacement Estrogens Progesterone Indications for replacement Cases

4 Outline Hormones and the Menstrual cycle Ovarian hormone replacement Estrogens Progesterone Indications for replacement Cases

5 Menstrual cycle

6 Follicular phase estrogen endometrial proliferation cervical mucous Follicular phase Luteal phase Ovulation Luteal phase progesterone endometrial maturation cervical mucous Menses

7 Cervical mucous changes Follicular phase Luteal phase Basal Body Temperature

8 Insulin LH Estrogen production Cholesterol Pregnenolone THECA CELL Progesterone GRANULOSA CELL FSH 17-OH Progesterone Androstenedione Aromatase Estrone Estradiol Testosterone

9 Estrogen crucial for the development of the antrum and maturation of the Graafian follicle actions of estradiol induction of FSH receptors on granulosa cells, proliferation and secretion of follicular thecal cells, induction of LH receptors on granulosa cells proliferation of endometrial stromal and epithelial cells E type cervical mucous

10 Estrogen feedback on LH and FSH Negative feedback At low circulating levels Positive feedback At very high levels Positive feedback loop on itself Estrogen induced proliferation of estrogen-converting granulosa cells and synthesis of estrogen receptors

11

12 Serum Estradiol Levels Estradiol (pmol/l) P-4 P-2 P P+2 P+3 P+5 P+7 P+9 P+11 Cycle day

13

14 Progesterone secreted by luteinized follicles requires p450 enzyme two circulating forms Progesterone 17-hydroxy-progesterone

15 Progesterone stimulate the release of proteolytic enzymes from thecal cells prepare for ovulation induce migration of blood vessels into the follicle wall stimulate prostaglandin secretion in follicular tissues induce swelling and increased secretion of the endometrium

16 Serum Progesterone Levels Serum Progesterone nmol/l P+3 P+5 P+7 P+9 P+11 Cycle day

17 Hormone levels 450 pmol/l 50 nmol/l

18 Outline Hormones and the Menstrual cycle Ovarian hormone replacement Estrogens Progesterone Indications for replacement Cases

19 Bioavailable hormone replacement The Endocrine Society Position Statement there is little or no evidence to support the claim that bioidentical hormones are safer or more effective than the commonly used synthetic versions of hormone replacement therapy (HRT) US Food and Drug Administration has ordered pharmacies to stop providing estriol, stating that it is a new, unapproved drug with unknown safety and effectiveness Endocrine Society. Bioidentical Hormones Position Statement, October

20 Bioavailable hormone replacement Bioidentical hormones chemical structure identical to human hormones chemically synthesized, such as progesterone, estriol, and estradiol Non-bioidentical hormones not structurally identical to human hormones chemically synthesized (MPA) derived from a nonhuman source (CEE)

21 Estradiol 17-B estradiol Ethynyl estradiol Conjugated equine estrogen Risk/benefits

22 Estrogen the fountain of youth?

23 Estradiol Transdermal patch Oral Vaginal

24 Oral estradiol Estrace Cost 0.5 mg $ mg $ mg $ tablets

25 Estrogel estradiol-17β hemihydrate Two metered-actuations = 2.5 g of gel (1.5 mg E2) Application instructions apply ESTROGEL to both arms alternate sites of application are the abdomen or the inner thighs must not be applied to the breasts, the face or to irritated or damaged skin allow the gel to dry approximately 2 minutes before covering with clothing

26 Transdermal estradiol Estraderm Cost 25ug patch ($41.88) 100ug patch ($48.27) 30 days supply

27 Transdermal estradiol Estradot Cost 25ug $34.88/bx of ug $34.93/bx of 8 50ug $36.57/bx 75ug $38.20/bx 100ug $39.73/bx 8 30 days supply

28 Transdermal estrogens Climara Osclim

29 Transdermal estrogens Files JA et al. Mayo Clin Proc 2011;86:673

30 Estring estradiol-17β indicated for the postmenopausal urogenital complaints due to estrogen deficiency drug reservoir of 2 mg estradiol releases 7.5 µg/24 hours over 90 days Cost ODB benefit

31 Vagifem 25ug or 10ug vaginal tablet with applicator ODB benefit

32 FDA approved vaginal estradiol Estring Ring 7.5ug/d q 90days Femring Ring 0.05 or 0.1mg q 90days Vagifem Tablet 10ug 1/d x 1 wk then 2-3x/wk Estrace cream 0.1mg/g Maintenance 1g 2-3x/wk

33 Human estrogens Hormone Human Estrone E % Estradiol E % Estriol E %

34 Compounded estrogen Original Tri-Est (2.5 mg) Estrone (10%) 0.25 mg Estradiol (10%) 0.25 mg Estriol (80%)2.0 mg Original Bi-Est (2.5 mg) Estradiol (20%) 0.5 mg Estriol (80%) 2.0 mg

35

36 C.E.S. Premarin or generic conjugated estrogens Tablets 0.3 mg, mg, 0.9 mg, 1.25 mg Cost ODB benefit

37 Human estrogens Hormone Human C.E.S - Premarin Estrone E % 75-80% Estradiol E % 5-15% Estriol E % Equilin 6-15%

38 Ethinyl estradiol Estrogen-like component in the OCP Physiologic replacement 0.05 mg OCP doses mg

39 Ethinyl estradiol vs 17B estradiol Adverse effect on hepatic protein synthesis induction and hemostatic parameters vs. 17-B estradiol Increased D-dimer, prothrombin, fibrinogen, mean APC sensitivity ratio Klipping C et al. Drugs in R&D 2011;11:159 Helgason S. Acta Obstet Gynecol Scand Suppl 1982; 107: 1-29 Lindberg UB et al. Thromb Haemost 1989;61:65 Mashchak CA et al. Am J Obstet Gynecol 1982;144:511 Wiegratz I et al. Contraception 2004;70:97

40

41 Estrogen equivalent effects Conjugated Estrogens Tri-Est or BiEst Estriol Estradiol Estradiol transdermal Estropipate (Ogen) Ethynil estradiol 0.625mg 2.5 mg 5 mg 1 mg 0.05 mg/24 hrs 0.75 mg 0.05 mg

42 Outline Hormones and the Menstrual cycle Ovarian hormone replacement Estrogens Progesterone Indications for replacement Cases

43 Progesterone

44 Prometrium micronized progesterone 100 mg. Nonmedicinal ingredients arachis (peanut) oil Dose 300mg PV or PO hs x 10d/month = luteal levels Cost bottle of 100 $52.75 price includes markup and $10.99 dispensing fee

45 Crinone g CRINONE 8% Vaginal Gel 90 mg progesterone intravaginally once or twice daily Cost Boxes of 18 $ price includes markup and $10.99 dispensing fee

46 Endometrin 100 mg progesteron effervescent vaginal tablets packed individually in a sealed foil pouch + applicator Cost Cartons packed with 21 vaginal tablets $ price includes markup and $10.99 dispensing fee

47 Progesterone Compounded Vaginal suppositories Transdermal Transbuccal troche Cost Suppositories 200mg $28.68/12 + dispensing fee

48 Cytex Progesterone Injection USP Dose 100mg CD 17, 21, mg 2/week pregnancy Cost 10 ml vial (50mg/ml) $80.29 price includes markup and $10.99 dispensing fee

49 Provera medroxyprogesterone acetate Progestin Cost 5mg $16.96/30 tabs 10mg $19.00/30 tabs price includes markup and $10.99 dispensing fee ODB benefit

50 Progestin equivalent effects Progesterone MPA mg 10mg

51 Progesterone vs. MPA Indistinguishable effects on endometrium Different effects on: Breast tissue proliferation Estrogen receptors Lipids Insulin resistance Vascular endothelium Hermsmeyer, RK Nature Clinical Practice Cardiovascular Medicine 2008;5:

52 Symptomatic efficacy for HRT Postmenopausal patients on HRT (4 studies) P4 vs. MPA resulted in: Greater satisfaction Fewer side effects Improved quality of life Hermsmeyer, RK Nature Clinical Practice Cardiovascular Medicine 2008;5:

53 Symptomatic efficacy for HRT P4 vs. MPA resulted in a decrease of: 30% sleep problems 50% anxiety 60% depression 30% somatic symptoms 25% menstrual bleeding 40% cognitive difficulties 30% sexual dysfunction 65% overall preference for P4 vs. MPA Fitzpatrick LA et al. J Womens Health Gend Based Med 2000;9:381

54 Symptomatic efficacy for HRT RCT MPA (vs. P4) resulted in: Increased vaginal bleeding p=0.003 Increased breast tenderness p=0.02 Trend for increased hot flashes PEPI trial 875 women CEE + MPA vs. P4 P4 fewer episodes of excessive bleeding No difference in symptomatic relief Cussings JA et al. Menopause 2002;9:253 Greendale GA et al. Obstet Gynecol 1989;92:982

55 Breast tissue effects Synthetic progestogens: Anti-apoptotic effects Increase estrogen-stimulated breast cell mitosis and proliferation Bind to estrogen receptors in breast tissue (not in endometrial tissue) resulting in estrogenic effects Increase conversion of weaker to more potent estrogens Estrone sulphate to active estrone Holtorf K Postgrad Med 2009;121:1

56 Breast tissue effects Progesterone Inhibits estrogen-stimulated breast epithelial cells Anti-estrogenic activity in breast tissue Downregulates ER-1 Induces breast cancer cell apoptosis Diminishes breast cell mitotic activity Arrest human breast cancer cells in G1 Upregulates cyclin-depepdent kinase inhibitors Downregulates cyclin D1 Holtorf K Postgrad Med 2009;121:1

57 Breast tissue effects 3 subclasses of progesterone receptors PRA, PRB, PRC Ratio PRA:PRB 1:1 in normal tissue Altered ratio in breast cancer cells Progestins alter normal ratio P4 no effect Holtorf K Postgrad Med 2009;121:1

58 Breast cancer risk with MPA Women s Health Initiative CES + MPA Breast cancer 1.26 (95% CI ) Nurses Health Study Addition of progestin to Estrogen 67% increase risk of breast cancer (95% CI ) Holtorf K Postgrad Med 2009;121:1

59 Breast cancer risk with Progesterone E3N-EPIC cohort - 80,000 women compared with women with no HRT Estrogen only 1.29 (p=0.73) E + synthetic progestin 1.69 (p=0.01) E + progesterone 0.9 (p=0.001) Fournier A et al. Int J Cancer 2005;114:448 Fournier A et al. Breast Cancer Res Treat 2008;107:103

60

61 Progesterone deficiency Prospective cohort 1083 infertile women Followed for years In women with low progesterone levels (vs. high) Premenopausal breast cancer risk 5.4x higher (95% CI ) Death from cancer 10x higher (95%CI ) Cowen LD et al. Am J Epidemiol 1981;114:

62 Progesterone deficiency Prospective cohort 5963 women Luteal progesterone levels compared with subsequent risk of breast cancer P4 inversely associated with breast ca risk Highest vs. lowest tertile RR=0.40, 95%CI , p=0.077 In women with normal menses (accurate timing) RR=0.12, 95%CI , p=0.005 Micheli A et al. Int J Cancer 2004;112:312

63 Progesterone deficiency Nestled case-control study T3 progesterone levels ( ) and risk of breast cancer ( ) 194 cases vs. 374 controls P4 inversely associated with breast ca risk Highest (> ng/ml) vs. lowest (< ng/ml) quartile RR=0.49, 95%CI , p for trend=0.08 In women dx with cancer at or before age 50 RR=0.3, 95%CI , p=0.04 Peck JD et al. Cancer Epidemiol Biomarkers Prev 2002;11:361

64 Cardiovascular risk HDL effect MPA consistently reduces HDL Progesterone maintains or augments estrogen s positive lipid and HDL effects Vascular cell adhesion molecule-1 (VCAM-1) Expressed early in atherosclerotic process Progesterone inhibits VCAM-1 No effect with MPA Holtorf K Postgrad Med 2009;121:1

65 Hermsmeyer, RK Nature Clinical Practice Cardiovascular Medicine 2008;5:

66 Synthetic vs. natural progesterone Hermsmeyer, RK Nature Clinical Practice Cardiovascular Medicine 2008;5:

67 Progestins in OCP chemical derivatives of testosterone (known as 19- nortestosterone derivatives) estrane family first generation progestins Norethindrone other progestins that metabolize to norethindrone (norethindrone acetate and ethynodiol diacetate) gonane family second generation progestins, which have varying degrees of androgenic and estrogenic activities levonorgestrel norgestrel

68 Progestins in OCP Third generation progestins The least androgenic effects Desogestrel Norgestimate. Drospirenone newest (4th) generation derived from 17a-spirolactone Third (and forth) generation progestins highly selective minimal androgenic properties may carry a higher risk of blood clots

69 Outline Hormones and the Menstrual cycle Ovarian hormone replacement Estrogens Progesterone Indications for replacement Cases

70 Indications for OHRT Premature ovarian failure Turner s syndrome Peri/post-menopausal symptoms Subfertility Holtorf K Postgraduate Medicine 2009;121:1-13

71 Indications for progesterone Anovulation PCOS Dysfunctional uterine bleeding PMS Luteal phase defects Recurrent miscarriage Peri/post-menopausal symptoms DiRenzo GC Curr Opin Obstet Gynecol 2005;17:598 Holtorf K Postgraduate Medicine 2009;121:1-13

72 Outline Hormones and the Menstrual cycle Ovarian hormone replacement Estrogens Progesterone Indications for replacement Cases

73 Case 1

74 Case 1 32F amenorrhea x 6 months HCG negative Negative progesterone withdrawal

75 Case 1 32F amenorrhea x 6 months HCG negative Negative progesterone withdrawal FSH 76 IU/L LH 46 IU/L Estradiol <18

76 Case 1 32F amenorrhea x 6 months HCG negative Negative progesterone withdrawal FSH 76 IU/L LH 46 IU/L Estradiol <18 No vasomotor symptoms Mild dyspareunia due to vaginal dryness

77 Estrogen equivalent effects Conjugated Estrogens Tri-Est or BiEst Estriol Estradiol Estradiol transdermal Estropipate (Ogen) Ethynil estradiol 0.625mg 2.5 mg 5 mg 1 mg 0.05 mg/24 hrs 0.75 mg 0.05 mg

78 Estrogen Transdermal estradiol Start 25-50ug Calendar day 1-27 Avoid estrogen dominant symptoms Breast tenderness Headaches Titrate based on Symptoms Target estradiol level 200 pmol/l for women <50

79 Progestin equivalent effects Progesterone MPA mg 10mg

80 Progesterone Prometrium 200mg PV/PO hs 100mg/25ug estradiol Calendar day Prime uterus for one month with estradiol only then add progesterone

81 Progesterone Titrate based on Withdrawal bleeding Symptoms Target progesterone level 15 nmol/l per 100 mg Eg. On 200mg around 30 nmol/l

82 Questions What if she was 45? When would you stop hormones and how? What is she didn t want to cycle? What if she is ODSB? What if she wants to conceive?

83 Case 2 - PCOS

84 Case 2 - PCOS 28F PCOS Anovulatory bleeding Every 6-10 weeks Acne No hirsuitism Impaired glucose tolerance Trying to conceive

85 Case 2 - PCOS Withdrawal bleeding Provera 10mg PO x 10 d/m Prometrium 300mg PV or PO HS x 10 d/m Progesterone vaginal suppositories 300mg PV

86 Cervical mucous changes Follicular phase Luteal phase Basal Body Temperature

87 Case 3 Perimenopausal DUB

88 Case 3 Perimenopausal DUB 47F G3P1 Dysfunctional uterine bleeding Menometrorrhagia day cycles Up to 6 weeks of continuous bleeding very light SHG no polyps or fibroids No coagulopathy Advised to get hysterectomy or endometrial ablation

89 Age 36 Age 47 Estradiol Progesterone

90 Cooperative progesterone Rx Progesterone mg PV hs for 10 days Progesterone 200 mg IM every 2 days until bleeding stops then monthly progesterone Progesterone 100 mg IM CD 17, 20, 23 Progesterone 300 mg PV CD 17-26

91 Outline Hormones and the Menstrual cycle Ovarian hormone replacement Estrogens Progesterone Indications for replacement Cases

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