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Table E-46. Therapies Used in Trials Comparing Hormone with Placebo Ar Est Study N Rxcat Dose Route Generic Trade M Dose Martin 1971 1 56 Plac Oral

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Table E-46. Therapies Used in Trials Comparing Hormone with Placebo Ar Est Study N Rxcat Dose Route Generic Trade M Dose Martin 1971 1 56 Plac Oral Table E-46. Therapies used in trials comparing hormone with placebo Ar Est Study N RxCat Dose Route Generic Trade m Dose Martin 1971 1 56 Plac Oral Standar 2 53 EP seq 0.025 mg E + 1 mg P Oral mestranol + norethindrone d 3 56 EP seq 0.05 mg E + 1 mg P Oral mestranol + norethindrone High Campbell 1 68 Plac Oral 1977 2 68 Est 1.25 mg Oral conjugated equine estrogens Premarin High Baumgardner 1 42 Plac Oral 1978 2 42 Est 0.1 mg Oral quinestrol Estrovis Low Standar 3 35 Est 0.2 mg Oral quinestrol Estrovis d 4 37 Est 1.25 mg Oral conjugated estrogen Premarin High E-65 Ar Est Study N RxCat Dose Route Generic Trade m Dose Coope 1981 1 26 Plac Oral UltraLo 2 29 Est 0.3mg Oral piperazine estrone sulphate w Jensen 1983 1 90 Plac Oral estradiol + estriol + 2 41 EP seq 4 mg E + 1 mg P Oral Trisequens Forte High norethisterone acetate Foidart 1991 1 53 Plac VagPes Ortho-Gynest- 2 56 Est 1 mg VagPes estriol Low Depot Eriksen 1992 1 79 Plac VagTab 2 75 Est 0.025 mg VagTab estradiol Vagifem Low Wiklund 1993 11 1 Plac Patch 1 11 Standar 2 Est 0.05 mg Patch estradiol 2 d Derman 1995 1 42 Plac Oral Standar 2 40 EP seq 2 mg E + 1 mg P Oral estradiol + norethindrone acetate Trisequens d Saletu 1995 1 32 Plac Patch Standar 2 32 Est 0.05 mg Patch estradiol Estraderm d Good 1996 1 91 Plac Patch Standar 2 88 Est 0.05 mg Patch estradiol Alora d 3 94 Est 0.10 mg Patch estradiol Alora High Speroff (Study 1) 1 54 Plac Patch 1996 UltraLo 2 54 Est 0.02 mg Patch estradiol FemPatch w E-66 Ar Est Study N RxCat Dose Route Generic Trade m Dose Chung 1996 1 40 Plac Oral Standar 2 43 Est 2mg Oral estradiol Estrofem d Speroff (Study 2) 1 37 Plac Patch 1996 UltraLo 2 37 Est 0.02 mg Patch estradiol FemPatch w 3 37 Est 0.04 mg Patch estradiol FemPatch Low Speroff (Study 3) 1 53 Plac Patch 1996 2 53 Est 0.04 mg Patch estradiol FemPatch Low Bacchi- 1 56 Plac Patch Modena 1997 Standar 2 53 Est 0.05 mg Patch estradiol Estraderm MX d Baerug 1998 1 41 Plac Oral EP 2 38 1mg E + 0.25mg P Oral estradiol + norethisterone acetate Activelle Low comb EP 3 40 1mg E + 0.5mg P Oral estradiol + norethisterone acetate Activelle Low comb Bech 1998 1 51 Plac Oral EP Standar 2 50 2 mg E + 1 mg P Oral estradiol + norethisterone acetate Kliogest comb d Trisekvens (also Standar 3 50 EP seq 2 mg E + 1 mg P Oral estradiol + norethisterone acetate Trisequens) d de Vrijer 1999 1 86 Plac Patch Standar 2 82 Est 0.05 mg Patch estradiol Estraderm MX 50 d E-67 Ar Est Study N RxCat Dose Route Generic Trade m Dose Estraderm MX 3 86 Est 0.10 mg Patch estradiol High 100 Leonetti 1999 SknCr 1 47 Plac m SknCr 2 43 Prog 20 mg progesterone m Studd 1999 1 60 Plac NasSpr Aerodiol + EP estradiol + medroxyprogesterone 2 58 0.1mg E + 5mg P NasSpr medroxyprogeste Low comb acetate rone acetate Aerodiol + EP estradiol + medroxyprogesterone 3 62 0.20mg E + 5mg P NasSpr medroxyprogeste Low comb acetate rone acetate Aerodiol + EP estradiol + medroxyprogesterone Standar 4 54 0.30mg E + 5mg P NasSpr medroxyprogeste comb acetate d rone acetate Aerodiol + EP estradiol + medroxyprogesterone 5 62 0.40mg E + 5mg P NasSpr medroxyprogeste High comb acetate rone acetate Polo-Kantola 1 32 Plac SknGel 1999 Estrogel or Standar 2 30 Est SknGel estradiol Evorel d Casper 1999 1 34 Plac VayRin 2 33 Est 0.0075 mg VayRin estradiol Estring Low Cohen 1999 12 1 Plac Patch 9 13 2 Est 0.0375mg Patch estradiol Vivelle Low 0 Rebar 2000 1 10 Plac Oral E-68 Ar Est Study N RxCat Dose Route Generic Trade m Dose 3 10 2 Est 0.3 mg Oral esterified estrogen Estratab Low 1 Speroff (Study 1) 1 43 Plac Oral 2000 EP 0.001 mg EE + 0.2 ethinyl estradiol (EE) + UltraLo 2 45 Oral FemHRT comb mg NA norethindrone acetate (NA) w EP 0.0025 mg EE + 0.5 ethinyl estradiol (EE) + 3 41 Oral FemHRT Low comb mg NA norethindrone acetate (NA) EP 0.005 mg EE + 1 mg ethinyl estradiol (EE) + 4 45 Oral FemHRT Low comb NA norethindrone acetate (NA) EP 0.010 mg EE + 1 mg ethinyl estradiol (EE) + Standar 5 45 Oral FemHRT comb NA norethindrone acetate (NA) d Rovati 2000 1 80 Plac Patch UltraLo 2 80 Est 0.025 mg Patch estradiol Dermestril w Standar 3 77 Est 0.05 mg Patch estradiol Dermestril d Standar 4 74 Est 0.05 mg Patch estradiol Dermestril d Notelovitz 1 49 Plac Oral 2000 2 48 Est 1 mg Oral estradiol Low UltraLo 3 48 Est 0.5 mg Oral estradiol w Strickler 2000 10 1 Plac Oral 5 Standar 2 96 Est 0.625 mg Oral conjugated equine estrogens d E-69 Ar Est Study N RxCat Dose Route Generic Trade m Dose Notelovitz 1 66 Plac Oral 2000 UltraLo 2 68 Est 0.25 mg Oral estradiol w UltraLo 3 64 Est 0.5 mg Oral estradiol w 4 67 Est 1.0 mg Oral estradiol Low Standar 5 68 Est 2.0 mg Oral estradiol d DeAloysio 1 52 Plac Patch 2000 UltraLo 2 52 Est 0.025 mg Patch estradiol Dermestril w 3 52 Est 0.0375 mg Patch estradiol Dermestril Low von Holst 1 93 Plac Patch 2000 Standar 2 93 Est 0.05 mg Patch estradiol Fem7 d Notelovitz 1 53 Plac Patch 2000 estradiol+ estradiol/norethindrone Vivelle + Standar 2 54 EP seq 0.050mg + 0.140mg Patch acetate CombiPatch d 0.050mg E + estradiol+ estradiol/norethindrone Vivelle + Standar 3 59 EP seq Patch 0.250mg P acetate CombiPatch d 0.050mg E + estradiol+ estradiol/norethindrone Vivelle + Standar 4 53 EP seq Patch 0.400mg P acetate CombiPatch d Alexandersen 1 50 Plac Oral 2000 0.75mg E + 0.35mg 2 50 EP seq Oral piperazine estrone sulphate + norethisterone Low P E-70 Ar Est Study N RxCat Dose Route Generic Trade m Dose Standar 3 50 EP seq 1.5mg E + 0.7mg P Oral piperazine estrone sulphate + norethisterone d EP Standar 4 50 2mg E + 1mg P Oral estradiol + norethisterone acetate comb d Speroff (Study 2) 1 67 Plac Oral 2000 EP 0.0025 mg EE + 0.5 ethinyl estradiol (EE) + 2 67 Oral FemHRT Low comb mg NA norethindrone acetate (NA) EP 0.005 mg EE + 1 mg ethinyl estradiol (EE) + 3 67 Oral FemHRT Low comb NA norethindrone acetate (NA) EP 0.010 mg EE + 1 mg ethinyl estradiol (EE) + Standar 4 65 Oral FemHRT comb NA norethindrone acetate (NA) d Rigano 2001 19 1 Plac 1 17 Standar 2 Est 0.05 mg Patch estradiol Dermestril 1 d Utian (CEE alone arms) 1 28 Plac Oral 2001 UltraLo 2 30 Est 0.3mg Oral conjugated equine estrogen w 3 32 Est 0.45mg Oral conjugated equine estrogen Low Standar 4 27 Est 0.625mg Oral conjugated equine estrogen d Simon 2001 1 48 Plac Oral Standar 2 72 Est 0.625 mg Oral synthetic conjugated estrogen-A Cenestin d Soares 2001 1 25 Plac Patch 2 25 Est 0.1 mg Patch estradiol Systen/Evorel High E-71 Ar Est Study N RxCat Dose Route Generic Trade m Dose Utian (CEE/MPA 1 28 Plac Oral arms) 2001 EP conjugated equine estrogen + medroxyprogesterone UltraLo 2 33 0.3mg E + 1.5mg P Oral comb acetate w EP conjugated equine estrogen + medroxyprogesterone 3 29 0.45mg E + 1.5mg P Oral Low comb acetate EP conjugated equine estrogen + medroxyprogesterone 4 28 0.45mg E + 2.5mg P Oral Low comb acetate EP 0.625mg E + 2.5mg conjugated equine estrogen + medroxyprogesterone Standar 5 34 Oral comb P acetate d Rozenbaum 1 57 Plac NasSpr 2002 2 54 Est 0.15 mg NasSpr estradiol Aerodiol Low Standar 3 54 Est 0.30 mg NasSpr estradiol Aerodiol d Shulman (Study 1) 1 93 Plac Patch 2002 EP 0.045 mg E + 0.030 2 96 Patch estradiol + levonorgestrel Low comb mg P 10 EP 0.045 mg E + 0.040 3 Patch estradiol + levonorgestrel Low 4 comb mg P von Holst 1 88 Plac Patch 2002 0.05 mg E + 0.01 mg Standar 2 84 EP seq Patch estradiol + levonorogestrel Fem7 Combi P d Archer 2003 1 73 Plac SknGel 2 75 Est 0.75 mg SknGel estradiol EstroGel Low 3 73 Est 1.5 mg SknGel estradiol EstroGel Low E-72 Ar Est Study N RxCat Dose Route Generic Trade m Dose Vestergaard 50 1 Plac Oral 2003 4 50 Standar 2 EP seq 2 mg E + 1 mg P Oral estradiol + norethisterone acetate Trisequens 2 d Speroff 2003 10 1 Plac VayRin 8 11 EP 2 0.05 mg VayRin estradiol + progestin Femring High 3 comb 11 EP 3 0.10 mg VayRin estradiol + progestin Femring High 2 comb Jirapinyo 1 60 Plac Oral 2003 EP Standar 2 60 2 mg E + 1 mg P Oral estradiol + norethisterone acetate Kliogest comb d Haines 2003 1 50 Plac Oral 2 52 Est 1 mg Oral estradiol Low Standar 3 50 Est 2 mg Oral estradiol d Hays 2003 81 1 Plac Oral 02 85 EP 0.625mg E + 2.5mg conjugated equine estrogen + Standar 2 Oral Prempro 06 comb P medroxyprogesterone acetate d Gambacciani 1 25 Plac Oral 2003 EP 2 25 1 mg E + 0.5 mg P Oral estradiol + norethisterone Activelle Low comb Gelfand 2003 1 60 Plac Oral EP 2 59 1 mg E + 0.09 mg P Oral estradiol + norgestimate Ortho-Prefest Low comb Wren 2003 1 42 Plac SknCr E-73 Ar Est Study N RxCat Dose Route Generic Trade m Dose m SknCr 2 38 Prog 32 mg progesterone Pro-Feme m Simunic 2003 78 1 Plac VagTab 4 82 2 Est 0.025mg VagTab estradiol Vagifem Low 8 Parsons 2003 VagCr Replens (nonhormonal 1 46 Plac m moisturizer) VagCr Standar 2 48 Est 0.625 mg conjugated estrogen Premarin m d Berlex (SIP) 1 88 Plac Patch 2003 EP .045 mg E + .03 mg Standar 2 92 Patch Estradiol + Levonorgestrel Climara Pro comb P d Rudolph 2004 1 64 Plac Oral EP Climodien/Lafam 2 65 2mg E + 2mg P Oral estradiol valerate + dienogest High comb me Yang 2004 1 25 Plac Oral EP 0.625mg E + 2.5mg conjugated estrogen + Standar 2 26 Oral Premelle comb P medroxyprogesterone acetate d Schurmann 1 61 Plac Oral 2004 EP 2 55 1mg E + 1mg P Oral estradiol + drospirenone Low comb EP 3 52 1mg E + 2mg P Oral estradiol + drospirenone Low comb EP 4 57 1mg E + 3mg P Oral estradiol + drospirenone Low comb Utian 2004 1 72 Plac Oral E-74 Ar Est Study N RxCat Dose Route Generic Trade m Dose UltraLo 2 68 Est 0.3mg Oral synthetic conjugated estrogen Enjuvia w Standar 3 72 Est 0.625mg Oral synthetic conjugated estrogen Enjuvia d 4 69 Est 1.25mg Oral synthetic conjugated estrogen Enjuvia High Dessole 2004 VagOv 1 44 Plac u
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