Table E-51. Therapies used in trials comparing hormone with hormone Ar Rout Est Generic Trade Study m N RxCat Dose e Dose 0.625 mg E + 10 conjugated equine estrogens + medroxyprogesterone Standar Polvani 1991 1 170 EP seq mg P Oral acetate d 0.05 mg E + 10 estradiol + medroxyprogesterone acetate Standar 2 203 EP seq mg P Patch d Henriksson VayRi estradiol Silastic 1994 1 106 Est 0.0095mg n Low VagP estriol Ovesterin 2 51 Est 0.5mg es Low 0.625 mg E + 20 conjugated estrogen + Premarin + Duphaston Standar Studd 1995 1 104 EP seq mg P Oral dydrogesterone d 0.05 mg E + 20 estradiol + dydrogesterone Menorest + Duphaston Standar 2 100 EP seq mg P Patch d VayRi estradiol Estring Ayton 1996 1 131 Est 0.0075mg n Low VagC conjugated estrogen Premarin Standar 2 63 Est 0.625mg rm d

E-96

Ar Rout Est Generic Trade Study m N RxCat Dose e Dose 0.625mg E + conjugated equine estrogen + Premarin + Provera Standar Hilditch 1996 1 35 EP seq 10mg P Oral medroxyprogesterone acetate d 0.014mg E + estradiol + medroxyprogesterone Estraderm + Provera UltraLo 2 39 EP seq 10mg P Patch acetate w estradiol valerate + Dilena or Divina Egarter 1996 1 51 EP seq 2mg E + 10mg P Oral medroxyprogesterone acetate High 0.625mg E + conjugated estrogen + Premarin + Colpron Standar 2 50 EP seq 10mg P Oral medrogestone d Hirvonen 1.0 mg E + 10 mg SknG estradiol + peroral Divigel + Terolut 1997 1 60 EP seq P el dydrogesterone Low 0.05 mg E + 10 estradiol + peroral Estraderm + Terolut Standar 2 60 EP seq mg P Patch dydrogesterone d Hirvonen SknG estradiol + medroxyprogesterone Divigel + Provera 1997 1 84 EP seq 1 mg E + 20 mg P el acetate Low SknG estradiol + medroxyprogesterone Divigel + Provera Standar 2 32 EP seq 2 mg E + 10 mg P el acetate d estradiol valerate + Divina 3 57 EP seq 2 mg E + 10 mg P Oral medroxyprogesterone High Rozenberg EP 0.05 mg E + P estradiol + dydrogerterone or estradiol + norethisterone Standar 1997 1 153 comb (see comment) Patch d EP 0.05 mg E + 0.17 estradiol + norethisterone acetate Standar 2 154 comb mg P Patch d EP 0.05 mg E + 0.35 estradiol + norethisterone acetate Standar 3 158 comb P Patch d 0.05 mg E + 0.17 estradiol + norethisterone acetate Standar 4 153 EP seq mg P Patch d 0.05 mg E + 0.35 estradiol + norethisterone acetate Standar 5 156 EP seq mg P Patch d Al -Azzawi estradiol Estraderm Standar 1997 1 129 Est 0.05 mg Patch d

E-97

Ar Rout Est Generic Trade Study m N RxCat Dose e Dose estradiol Lyrelle 50 Standar 2 134 Est 0.05 mg Patch d 3 131 Est 0.08 mg Patch estradiol Lyrelle 80 High 123 EP 0.05 mg E + ? mg estradiol + progestogen Menorest + progestogen Standar Lubbert 1997 1 2 comb P Patch d 122 estradiol + progestogen Menorest + progestogen Standar 2 7 EP seq 0.05 mg + ? mg P Patch d Barentsen VayRi estradiol Estring 1997 1 83 Est 0.0075mg n Low VagC estriol Synapause 2 82 Est 0.5mg rm Low Bachmann EP VayRi estradiol + medroxyprogesterone Estring 1997 1 129 comb 0.0075mg n Low VagC conjugated equine estrogen Premarin Standar 2 67 Est 0.625 mg rm d conjugated equine estrogen Premarin Standar Good 1999 1 79 Est 0.625 mg Oral d 2 82 Est 1.25 mg Oral conjugated equine estrogen Premarin High estradiol Alora Standar 3 80 Est 0.05 mg Patch d 4 80 Est 0.1 mg Patch estradiol Alora High Mattsson estradiol + dydrogesterone Standar 2000 1 342 EP seq 2 mg E + 10 mg P Oral d 0.3 mg E + 10 mg NasS estradiol + dydrogesterone Aerodiol Standar 2 317 EP seq P pr d estradiol (E2) + desogestrel Liseta Standar Saure 2000 1 186 EP seq 1.5 mg E + 0.15 P Oral d estradiol valerate + Klimalet 2 190 EP seq 2 mg E + 10 mg P Oral medroxyprogesterone acetate High Graser 2000 1 199 EP 2 mg E + 2 mg P Oral estradiol valerate + dienogest Climodien High

E-98

Ar Rout Est Generic Trade Study m N RxCat Dose e Dose comb EP estradiol valerate + dienogest 2 186 comb 2 mg E + 3 mg P Oral High EP 2 mg E + 1 mg estradiol + estriol + Kliogest Standar 3 196 comb Estriol + 1.0 mg P Oral norethisterone acetate d VagT estradiol Vagifem Rioux 2000 1 80 Est 0.025 mg ab Low VagC conjugated equine estrogen Premarin Standar 2 79 Est 1.25 mg rm d VagT estradiol Vagifem Dugal 2000 1 48 Est 0.025 mg ab Low VagP estriol Ovesterin 2 48 Est 0.5 mg es Low estradiol Climara UltraLo Parsey 2000 1 95 Est 0.025mg Patch w conjugated equine estrogen Premarin UltraLo 2 98 Est 0.3mg Oral w Meuwissen estradiol valerate + norgestrel Cyclocur 2001 1 314 EP seq 2mg E + 0.5mg P Oral High estradiol + trimegestone Standar 2 320 EP seq 2mg E + 0.5mg P Oral d 0.05 mg E + 10 or estradiol + dydrogesterone Estraderm + Standar Lopes 2001 1 185 EP seq 20 mg P Patch dydrogesterone d 0.3 mg E + 10 or NasS estradiol + dydrogesterone Aerodiol + Standar 2 176 EP seq 20 mg P pr dydrogesterone d estradiol + medroxyprogesterone acetate Standar Ozsoy 2002 1 100 EP seq 2 mg E + 5 mg P Oral d estradiol + medroxyprogesterone Aerodiol + 0.300 mg E + 5 NasS acetate medroxyprogesterone Standar 2 101 EP seq mg P pr acetate d

E-99

Ar Rout Est Generic Trade Study m N RxCat Dose e Dose EP estradiol + norethisterone acetate Loh 2002 1 48 comb 1mg E + 0.5mg P Oral Low EP estradiol + norethisterone acetate Standar 2 48 comb 2mg E + 1mg P Oral d Buckler (d) estradiol + norethisterone Elleste Solo + Micronor- 2003 1 75 EP seq 1 mg E + 1 mg P Oral HRT Low 0.05 mg E + 1 mg VayRi estradiol acetate + Menoring + Micronor- 2 84 EP seq P n norethisterone HRT High EP esterified estrogens Estratab Standar Lobo 2003 1 111 comb 0.625 mg Oral d ET 0.625 mg E + esterified estrogens + Estratest-HS Standar 2 107 comb 1.25 mg T Oral methyltestosterone d Pornel 2005 1 387 EP seq 1 mg E + 0.25 P Oral estradiol + trimegestone Totelle Low estradiol valerate + Climagest Standar 2 377 EP seq 1 mg E + 1 mg P Oral norethisterone d Gambacciani EP 1 mg E + 0.125 estradiol + trimegestone 2005 1 432 comb mg P Oral Low EP 1 mg E + 0.5 mg estradiol + norethisterone 2 242 comb P Oral Low EP estradiol + norethisterone Standar 3 176 comb 2 mg E + 1 mg P Oral d EP estradiol acetate + progestin Femtrace Standar Utian 2005 1 79 comb 0.9 mg Oral d EP conjugated equine estrogens + Premarin Standar 2 85 comb 0.625 mg Oral progestin d EP estradiol + progestin Estrace 3 84 comb 1 mg Oral Low estradiol Estraderm Standar Davis 2005 1 60 Est 0.05 mg Patch d 2 60 Est 0.30 mg NasS estradiol Aerodiol Standar

E-100

Ar Rout Est Generic Trade Study m N RxCat Dose e Dose pr d Raynaud 0.05 mg + 1.2mg estradiol + norethisterone Oesclim + Milligynon Standar 2005 1 136 EP seq P Patch acetate d 0.04 mg + 1.2mg estradiol + norethisterone Estrapatch + Milligynon 2 134 EP seq P Patch acetate Low 0.06 mg E + 1.2m estradiol + norethisterone Estrapatch + Milligynon 3 135 EP seq P Patch acetate High Braunstein 2005 1 119 Est Patch ET ? mg E + 0.15 mg estrogen + testosterone 2 106 comb T Patch ET ? mg E + 0.3 mg estrogen + testosterone 3 110 comb T Patch ET ? mg E + 0.45 mg estrogen + testosterone 4 111 comb T Patch Simon 2005 1 279 Est Patch 2 283 Test 0.3 mg Patch testosterone Weisberg VayRi estradiol ESTring 2005 1 126 Est 0.008mg n Low VagT estradiol Vagifem 2 59 Est 0.025mg ab Low Buster 2005 1 266 Est Patch 2 266 Test 0.3 mg Patch testosterone conjugated equine estrogen + Premarin + MPA EP 0.625 mg E + 2.5 depomedroxyprogesterone Standar Akhila 2006 1 35 comb mg P Oral acetate d estradiol + Estrogel + MPA EP 1.5 mg E + 2.5 SknG depomedroxyprogesterone Standar 2 25 comb mg P el acetate d 3 28 EP 0.05 mg E + 2.5 Patch estradiol + Estraderm + MPA Standar

E-101

Ar Rout Est Generic Trade Study m N RxCat Dose e Dose comb mg P depomedroxyprogesterone d acetate conjugated estrogens + Premarin + 0.625 mg E + 10 medroxyprogesterone acetate medroxyprogesterone Standar Serrano 2006 1 55 EP seq mg P Oral acetate d estradiol + medroxyprogesterone Climara + 0.05 mg + 10 mg acetate medroxyprogesterone Standar 2 59 EP seq P Patch acetate d Cieraad 2006 1 98 EP seq 1 mg E + 10 mg P Oral estradiol + dydrogesterone Low 0.625 mg E + conjugated equine estrogens + norgestrel Standar 2 91 EP seq 0.15 mg P Oral d Davis 2006 1 39 Est Patch ET 2 37 comb ?mg E + 0.3 mg T Patch conjugated equine estrogen Standar Long 2006 1 37 Est 0.625mg Oral d 0.625mg/1g VagC conjugated equine estrogen Premarin Standar 2 36 Est cream rm d EP Shifren 2006 1 273 comb ?mg E Patch ET testosterone 2 276 comb ?mg E + 0.3 mg T Patch Limpaphayom EP 0.3 mg E + 1.5 conjugated estrogens + medroxyprogesterone acetate UltraLo (m) 2006 1 342 comb mg P Oral w EP 0.45 mg E + 1.5 conjugated estrogens + medroxyprogesterone acetate 2 342 comb mg P Oral Low EP 0.625 mg E + 2.5 conjugated estrogens + medroxyprogesterone acetate Standar 3 344 comb mg P Oral d EP 0.3mg E + 90mg NasS estradiol + progesterone Aerodiol + Crinone Standar Odabasi 2007 1 32 comb P pr d

E-102

Ar Rout Est Generic Trade Study m N RxCat Dose e Dose EP 0.050mg E + estradiol + progesterone Climara + Crinone Standar 2 29 comb 90mg P Patch d Pitkin (d) EP 1 mg E + 2.5 mg estradiol valerate (E2V) + medroxyprogesterone acetate Standar 2007 1 152 comb P Oral (MPA) d EP estradiol valerate (E2V) + medroxyprogesterone acetate Standar 2 153 comb 1 mg E + 5 mg P Oral (MPA) d EP estradiol valerate (E2V) + medroxyprogesterone acetate 3 154 comb 2 mg E + 5 mg P Oral (MPA) High Penteado EP 0.625 mg E + 2.5 conjugated equine estrogens + medroxyprogesterone Standar 2008 1 27 comb mg P Oral acetate d ET 0.625 mg E + 2.5 conjugated equine estrogens + medroxyprogesterone Standar 2 29 comb mg P + 2.0 mg T Oral acetate + methyltestosterone d Panay 2010 1 142 Est Patch ET 2 130 comb 0.30 mg Patch (d): duplicate patient population with other included article; EP comb: estrogen plus progestin combined; EP seq: estrogen plus progestin sequential; Est: estrogen alone; ET comb: estrogen plus testosterone combine; (m): trial contains data from multiple publications; NasSpr: nasal spray; RxCat: treatment category; SknGel: skin gel; VagCrm: vaginal cream; VagOvu: vaginal ovule; VagPes: vaginal pessary; VagRin: vaginal ring; VagTab: vaginal tablet

E-103