Annex 2. Preparations of oestrogens, progestogens and combinations of oestrogens and progestogens that are or have been used as hormonal contraceptives and for post-menopausal hormonal therapy, with known trade names ANNEX 2 615 Trade names Neo-Eunomin Diane, Diane-35, Diane-Mite, Diane Nova, Dianette, Gynofen 35 Cycléane-20, Lovelle, Marvelon 20, Mercilon, Microdosis, Myralon, Securgin, Segurin Cycléane-30, Desogen, Desolett, Frilavon, Marvelon, Marvelon 30, Marviol, Microdiol, Novelon, Ortho-Cept, Planum, Practil,Prevenon, Varnoline Gracial Oviol Ovidol, Trimiron Valette Harmonet, Meliane Ciclomex, Evacin, Femodeen, Femoden, Femodene, Femovan, Ginera, Ginoden, Gynera, Gynovin, Minulet, Minulette, Moneva, Myvlar Tri- Tricilomex, Triadene, Phaeva, Milvane, Femoden, Trigynera, Tri-Gynera, Trigynovin, Triminulet, Triodeen, Trioden, Triodena, Triodene Miranova Minisiston, Monostep Dose (mg) 1/2 2 0.15 0.15 0.025/0.125 0/0.125 0.05/0.1/0.15 2 0.075 0.075 0.05/0.07/0.1 0.1 0.125 ns used in oral contraceptives, with known trade names trade with known contraceptives, oral in ns used Progestogen acetate Chlormadinone Cyproterone acetate Desogestrel Desogestrel Desogestrel Desogestrel Desogestrel Dienogest Gestodene Gestodene Gestodene Levonorgestrel Levonorgestrel g) μ Dose ( 50 35 20 30 40/30 50 35/30 30 20 30 30/40/30 20 30 Biphasic Monophasic Monophasic Monophasic Biphasic Biphasic Triphasic Monophasic Monophasic Monophasic Triphasic Monophasic Monophasic Table 1. Some combinations of oestrogens and progestoge and oestrogens of combinations Some 1. Table Combination Oestrogen Ethinyloestradiol 616 IARC MONOGRAPHS VOLUME 72 , a , a , Mithuri, a , Lo-Ovral a , Lorsax, Mala D, Microgest, D, Mala , Lorsax, a , Lo-Gentrol a , Ovranet, Ovranette, Riget, Ovranette, Ovranet, , a , Lo-Rondal a , Egogyn 30, Femigoa, Femranette mikro, a Trade names Ciclo, Ciclon, Combination 3, Contraceptive L.D., Duofem Pill, Levonorgestrel Levlen, Gynatrol, Follimin, Levora, Lo-Femenal Lo/Ovral Microginon 30, Mycrogyn, Microgyn 30, Microgynon, Microgynon 30, Microgynon-30, Microvlar, Minibora, Minidril, Minigynon, Minigynon 30, Minivlar, MinOvral Neovletta, Neomonovar, 150/30, Neo-Gentrol Pill Norgestrel 150/30, Nordette Nordette, Nordet, Norgylene, Norvetal, Ologyn-micro, Ovoplex 30/150, Ovral L Rigevidon, Sexcon, Stediril-30, Stediril-d 150/30, Stediril-M, Suginor 30, Eugynon-30, Eugynon 5, Combination Neogynon 30 MCG, Nordiol 30, Ovran 30, Primovlar-30 Ediwal, Gravistat 125, Microgynon, Microgynon-50, Minigynon 50, Neo-Gentrol 125/50, Neostediril, Stediril-50 Regunon, 50, Nordette Neo-Stediril, Dose (mg) 0.15 0.25 0.125 Progestogen Levonorgestrel Levonorgestrel Levonorgestrel g) μ Dose ( 30 30 50 Monophasic Monophasic Monophasic Table 1 (contd) Table 1 Combination Oestrogen (contd) Ethinyloestradiol ANNEX 2 617 , a , a , Stediril-d a , Contraceptive H.D., a , Anulit a , Gravistat, Gravistat 250, Gravistat , Gravistat, a , Ovral 0.25, Ovran, Planovar a , Eugynon 250, Evanor, Evanor-d, a , Primovlar-50, Stediril , Primovlar-50, , Denoval,, Denoval-Wyeth, D-Norginor, a a , Anulette a Trade names Anfertil Daphiron Duoluton, Duoluton L, Duotone, Dystrol, Eugynon Eugynon-50 Gentrol Follinett, Monovar, Neogentrol, Neo-Gentrol, Neo-Gentrol 250/50, Neogynon, Neogynona, Neo-Primovlar, Neovlar, Noral, Nordiol, Norginor, Normanor, Novogyn 21, Novogynon, Ologyn, Ovidon, Ovlar, Ovoplex, Ovral Primovlar Adepal, Adépal Anteovin, Binordiol, Biphasil, Bivlar, Duophasal, Sequilar, Sekvilar, Prolorfin, Perikursal, Normovlar, Sequilarum Fironetta, Levordiol, Logynon, Modutrol, Trigynon, Trigoa, Triette, Triciclor, Triagynon, Triovlar, Trionetta, Trinordiol, Tri-Levlen, Trikvilar, Triphasil, Triquilar, Tri-Regol, Trisiston, Tri- Trolit Stediril, Tristep Ginotex, Mini Pregnon, Ministat, Ovamezzo, Ovoresta M, Ovostat Micro, Restovar Yermonil Ermonil, Anacyclin, Lyndiol 1, Lyndiolett, Miniol, Noracyclin, Novostat, Ovoresta, Ovostat, Pregnon Dose (mg) 0.25 0.15/0.2 0.05/0.125 0.05/0.075/0.125 0.05/0.05/0.125 0.75 2 1 Progestogen Levonorgestrel Levonorgestrel Levonorgestrel Levonorgestrel Levonorgestrel Lynoestrenol Lynoestrenol Lynoestrenol g) μ Dose ( 50 30/40 50 30/40/30 30/50/40 37.5 40 50 Monophasic Biphasic Biphasic Triphasic Triphasic Monophasic Monophasic Monophasic Table 1 (contd) Table 1 Combination Oestrogen (contd) Ethinyloestradiol 618 IARC MONOGRAPHS VOLUME 72 Trade names Lindiol, Lindiol 2,5, Lyndiol, Lyndiol 2,5, Lyn- ratiopharm, Minilyn, Neo-Lyndiol, Ovariostat, Sukhi Fysioquens, Normofasico, Normophasic, Physiostat Lyn-radiopharm Sequenz, Ovanon No 2 OralPill Conceplan M, Sinovula mikro Micropil, Norquen, 35, Ovcon Oviprem E, 0.5/35 Gynex 0.5/35, Genora Brevinor, Brevicon, 0.5/35 Nelova Modicon, Plan, Mikro 5/35, Intercon E, Nilocan, Norminest, Orthonett Novum, Ovacon, Ovysmen 0.5/35,Perle LD No 1 OralPill Brevicon 1,Brevinor-1, Genora 1/35, 1/35 Gynex E, Intercon 1/35, Kanchan, Nelova 1+35 E, Neocon, Norcept-E1/35, Norimin, Norimin-1, Norinyl 1/35, Norquest, Ortho Novum 1/35, 1/35, Ovysmen Secure Anovulatorio MK, Apranax, Arona, Non-Ovlon, 50, Syntracept Ovcon Norlesterire, Binovum, Jenest, Nelova 10/11, Ortho Novum 10/11 Trinovum Triella, 7/7/7, Novum Ortho Improvil, Synfase, Synphase, Tri-Norinyl No 0 OralPill Minestril-20, 20, Loestrin 1/20, Loestrin Loestrin, Minestrin 1/20 Dose (mg) 2.5 0/1.0 0/2.5 1 0.5 0.4 0.5 0.6 1 1 0.5/1 0.5/0.75/1.0 0.5/1.0/0.5 0.5 + 0.3 1 Progestogen Lynoestrenol Lynoestrenol Lynoestrenol acetate Megestrol Norethisterone Norethisterone Norethisterone Norethisterone Norethisterone Norethisterone Norethisterone Norethisterone Norethisterone acetate + megestrol Norethisterone acetate Norethisterone g) μ Dose ( 50 50 35 30 35 50 35 35 35 20 Monophasic Biphasic Biphasic Monophasic Monophasic Monophasic Monophasic Monophasic Monophasic Monophasic Biphasic Triphasic Triphasic Monophasic Monophasic Table 1 (contd) Table 1 Combination Oestrogen (contd) Ethinyloestradiol ANNEX 2 619 Trade names Neorlest N, Mala 30, Loestrin Mite, 30, Econ Econ Trentovlane Minestril-30 1.5/30, Loestrin Loveston Milli- Anovulatorio, mg, Anovlar-1 1 mg, Anovlar Anovlar, Nodiol, Nonovlon, Non-Ovlon, Orlest, Prolestrin Econ, Gynovlane Norlestrin Gynovlar mg, Anovlar-3 Miniphase Sequostat Gynophase, Sinovula 35, Ortho-Cyclen Effiprev Effiprev, Cilest, Tricilest Pramino, Tri-Cyclen, Ortho Planor Piloval Dose (mg) 0.6 1 1.5 0.5 1 2 2.5 3 1/2 0/5 1/2 0.25 0.18/0.215/0.25 2 0.5 Progestogen acetate Norethisterone acetate Norethisterone acetate Norethisterone acetate Norethisterone acetate Norethisterone acetate Norethisterone acetate Norethisterone acetate Norethisterone acetate Norethisterone acetate Norethisterone Norgestimate Norgestimate Norgestrienone Quingestanol acetate g) μ Dose ( 30 30 30 50 50 50 50 50 30/40 50 35 35 50 50 Monophasic Monophasic Monophasic Monophasic Monophasic Monophasic Monophasic Monophasic Biphasic Biphasic Monophasic Triphasic Monophasic Monophasic Table 1 (contd) Table 1 Combination Oestrogen (contd) Ethinyloestradiol 620 IARC MONOGRAPHS VOLUME 72 Trade names (weekly) Deposiston Femigen, Gestamestrol N, Lutestral Angravid, Neo-Ovulen, Ovulen 50 Tridestan Combiginor, Conceplan, Conlumin, Genora 1+50, Gulaf, Nelova 1/50 Norimin, M, Norinyl, Norinyl-1, Norinyl 1/50, Norit, Orthonett 1/50, Ortho Novin 1/50, Ortho Novum 1/50,Perle, Plan mite, Ultranovulance Norbiogest Dose (mg) 0/5 2 1 0.05/0.075/0.125 1 1/2 Progestogen acetate Norethisterone acetate Chlormadinone Ethynodiol diacetate Levonorgestrel Norethisterone Norethisterone g) μ Dose ( 1/0 (mg) 50 50 30/40/30 50 50 Biphasic Monophasic Monophasic Triphasic Monophasic Biphasic Product containing norgestrel (levonorgestrel + dextronorgestrel) Table 1 (contd) Table 1 Combination Oestrogen sulfonate Ethinyloestradiol Mestranol (1996) Kleinman From a ANNEX 2 621 Countries in which available (not comprehensive) (not available in which Countries Kingdom United Africa, South Israel, Ethiopia, Australia, Sweden Romania, Morocco, France, Finland, Ethiopia, Denmark, Belgium, Australia, Venezuela Kingdom, United Sudan, Africa, South Kenya, Italy, Ireland, Germany, Ethiopia, Belgium, Australia, Algeria, Thailand Tanzania, Switzerland, Sudan, Mexico, Norway Finland, Denmark, Germany Kingdom United Slovakia, Republic, Czech Argentina Kingdom United Brazil Federation, Russian Nigeria, (Kinshasa), Congo of Republic Democratic States United Switzerland Sweden, Germany, (Kinshasa), Congo of Republic Democratic Belgium, Argentina, Algeria, Nigeria, Netherlands, Mexico, Iran, Indonesia, France, Finland, Ethiopia, Venezuela Thailand, Africa, South Peru, Romania, Portugal, Denmark, Iceland, Norway Norway Mexico Denmark Australia Federation, Russian Ireland, Germany, Canada, Brazil, Austria, Australia, States United Kingdom, United Switzerland, Sudan, Africa, South Denmark, Sweden Dose (mg) 0.5 0.03 0.03 0.03 0.03 0.03 0.0375 0.0375 0.03 0.03 0.0375 0.5 0.5 0.5 0.3 0.35 0.3 0.35 0.35 0.3 a a a Drug name Drug Femulen Follistrel Microval Microlut Microluton Mikro-30 Wyeth Neogest Norgeal Norgeston Nortrel Ovrette Exlutena Exluton Exlutona Conludag Dianor Gesta Plan Locilan Micronor Mini-Pe acetate Table 2. Some oral ‘progestogen-only’ contraceptives ‘progestogen-only’ oral Table 2. Some Composition di Ethynodiol Levonorgestrel Lynoestrenol Norethisterone 622 IARC MONOGRAPHS VOLUME 72 Countries in which available (not comprehensive) (not available in which Countries Finland Slovakia Republic, Czech Kingdom United Ireland, Australia, United States France Dose (mg) 0.3 0.3 0.35 0.35 0.35 Drug name Drug Mini-Pill Monogest Noriday Nor-QD Ogyline Product containing norgestrel (levonorgestrel and dextronorgestrel) and (levonorgestrel norgestrel containing Product Table 2 (contd) Table 2 Composition (contd) Norethisterone Norgestrienone (1996) Kleinman From a ANNEX 2 623 Countries or regions in which available (not comprehensive) (not available which in regions or Countries Kingdom United Korea, of Republic Zealand, New Europe, of much Canada, States United Africa, South States United Canada, States United Canada, States United Canada, Brazil, of most Europe, of most Canada, Australia, Asia, of Much Latin America, Middle East, Zealand, New Scandinavia, States United Africa, South United States Ecuador, America, Central Belgium, Austria, Argentina, East, Middle the of much Ireland, Indonesia, France, Finland, Africa, South Poland, Portugal, Philippines, Netherlands, Switzerland United States Scandinavia, Peru, Ireland, Germany, Argentina, Kingdom United Africa, South a a a Dose (mg) 1 2 0.05 0.1 10–40 0.02 0.05 0.5 1.0 2.0 0.025 0.05 0.1 0.3 0.625 1.25 2.5 2 (1) 4 (2) 0.625 1.25 2.5 0.025 0.05 0.075 0.1 oestriol) ± Composition valerate Oestradiol Oestradiol valerate Oestradiol Ethinyloestradiol Oestradiol Oestradiol oestrogensEsterified ( Oestradiol oestrogensEsterified Oestradiol Route Oral Patch Injectable Oral Oral Patch Oral Oral Oral Patch Table 3. Post-menopausal oestrogen-only hormonal therapy hormonal oestrogen-only Post-menopausal Table 3. name Drug Climaval Climara Delestrogen Estinyl Estrace Estraderm matrix Estraderm Estraderm mx Estraderm TTS Estratab Estrofem Forte Estrofem Evex Evorel 624 IARC MONOGRAPHS VOLUME 72 Canada, United Kingdom, United States United Kingdom, United Canada, States United Canada, Singapore, Europe, of most Colombia, Chile, Australia, Venezuela Kingdom United Thailand, Switzerland, Australia, Canada, Mexico, Venezuela, United States States United Africa, South Denmark Zealand, New Malaysia, (China), Kong Hong Denmark, States United Kingdom, United Countries or regions in which available (not comprehensive) (not available which in regions or Countries Austria, Finland, Germany, Netherlands, Sweden, Kingdom United Switzerland, Puerto Rico, UnitedStates United States a a 0.135/0.27 0.7/1.4 0.3/0.6 0.625 1.25 2.5 0.05 0.075 1.5 3 6 1.25 1/2/4 0.5/1/2 1 2 Dose (mg) 1.25 2.5 Composition Oestrone Oestradiol Oestriol Route MenestMenorest OralOestrogel oestrogens Esterified PatchOgen 0.3 Oestradiol GelOrthoest Oestradiol OralØstradiol-øestriol 0.037 OralOvestin Oral Oestropipate Oestradiol 0.75 Oestropipate Oral 0.75 Singapore, Malaysia, Israel, Ireland, Egypt, Belgium, Oestriol 0.625 0.5 HarmogenHormonin Oral Oral Oestrone Oestriol 0.93 Kingdom United Netherlands, Ecuador, FemPatch Patch Oestradiol 0.025 Table 3 (contd) Table 3 name Drug 7/sevenFem Femogen Patch Oestradiol Oral oestrogens Esterified 0.625 0.05 ANNEX 2 625 ich available (not comprehensive) (not available ich Australia, Canada, most of Europe, Japan, Latvia, Japan, Europe, of most Canada, Australia, States United South America, of most Africa, South Israel, (China), Kong Hong Europe, of most Australia, Federation, Russian Poland, Philippines, Malaysia, Africa South Singapore, United States States United Canada, Canada,Puerto Rico, United States United States Kingdom United Netherlands, Belgium, Austria, a ose (mg)ose wh in or regions Countries 0.625 0.9 1.25 2.5 2 0.625 1.25 2.5 20 0.05 0.075 0.1 1.25 2.5 2 Approximate dose per 24 h of use of h 24 per dose Approximate Table 3 (contd) Table 3 nameDrug Premarin Route Composition OralProgynova oestrogens Conjugated EstrogensSK Oral 0.3 D OralTriovex valerate Oestradiol Vallestril oestrogens Esterified 1 Vivelle 0.3 Oral OralZeste Oestriol Patch MethallenestrilZumenon Oestradiol 3 a Oral 1 Oral oestrogens Esterified 0.0375 Oestradiol 0.625 Sweden 1 626 IARC MONOGRAPHS VOLUME 72 Countries or regions in which available which in or regions Countries comprehensive) (not Kingdom United States United States United States United Canada, Kingdom United Africa, South Australia, Dose (mg) 5 1.25 2.5 10 1.25 2.5 3.6 Androgen Methyltestosterone Methyltestosterone Methyltestosterone Methyltestosterone Methyltestosterone Dose (mg) 0.01 0.625 1.25 1.25 0.02 0.04 0.04 Oestrogen Ethinyloestradiol oestrogensEsterified oestrogens Conjugated Ethinyloestradiol Ethinyloestradiol Route Oral Oral Oral Oral Oral Table 4. Combined oestrogen–androgen therapy oestrogen–androgen Table 4. Combined name Drug Climatone Estratest Formatrix Gynetone Mixogen ANNEX 2 627 Countries or regions in which available which in or regions Countries comprehensive) (not Kingdom United United Netherlands, Ireland, Germany, Kingdom Australia, Denmark, Finland,France, Greece, Morocco, Netherlands, Zealand, New Korea, of Republic Poland, Paraguay, South Sweden, Africa, Turkey (China), Kong Hong Europe, of Most New Malaysia, America, Latin Indonesia, Korea, of Republic Philippines, Zealand, Africa South Scandinavia, New Mexico, Ireland, Ecuador, Australia, Kingdom United Zealand, Kingdom United Kingdom United Latin of much Europe, of most Australia, America, Mexico, Morocco, Zealand, New Pakistan,South Africa, Taiwan, United States Africa, South Netherlands, Italy, Denmark, Kingdom United a a a a a Dose (mg) 1 2 1 1 0.25 2 0.5 2 10 0.05 0.25 0.05 0.1 0.04 0.08 10 1 2 10 2 (1) 1 2.5 b Composition Oestradiol (O) valerate (P) Norethisterone Oestradiol (O) valerate (P) Levonorgestrel Oestradiol (O) valerate Norgestrel (P) Oestradiol (O) valerate (P) acetate Medroxyprogesterone (O) Oestradiol (P) (2 weeks) acetate Norethisterone (O) Oestradiol (P) acetate Norethisterone (O) Oestradiol (P) weeks) (2 Dydrogesterone (O) Oestradiol (P) Dydrogesterone Oestradiol (O) oestriol) (or (P) acetate Norethisterone Tibolone Route Oral Oral Oral oral + Patch oral + Patch Patch Oral Oral Oral Oral Table 5. Post-menopausal oestrogen–progestogen therapy oestrogen–progestogen Post-menopausal Table 5. name Drug Climagest Cyclo-progynova Divina Estracombi, Estracomb Estrapak Femapak Femoston Kliofem Kliogest, Livial 628 IARC MONOGRAPHS VOLUME 72 Australia, Netherlands, United Kingdom United Netherlands, Australia, Australia, most of Europe, Indonesia, much Indonesia, Europe, of most Australia, of Latin America, Middle East, Zealand, New United Taiwan, Philippines, Pakistan, Kingdom United Kingdom United Puerto Rico, UnitedStates Puerto Rico, UnitedStates Most of Europe, Egypt, Kuwait, Malaysia, Kuwait, Egypt, Europe, of Most Arab United Africa, South Singapore, Emirates Ireland, United Kingdom United Ireland, Denmark, Ireland, Italy, New Zealand, New Italy, Ireland, Denmark, Kingdom United Spain, Portugal, United Kingdom United America Latin of Much (not comprehensive) (not e (mg)e available which in or regions Countries 4/1 1 2/1 1 2 20 0.625 2.5 0.625 5 0.625 1.25 0.15/0.5 0.625 5 2 0.075 0.0125–0.05 0.75–1.5 0.625 1.25 5 10 Norethisterone acetate (P) Norethisterone acetate (P) Medroxyprogesterone acetate (P) Medroxyprogesterone acetate (P) Medroxyprogesterone acetate (P) Norgestrel/medrogestone (P) Medroxyprogesterone acetate (P) Levonorgestrel (12 days) (P) days) (12 Levonorgestrel Norethisterone (P) Norethisterone Medroxyprogesterone acetate (P) Oral Oestradiol (O) Oral (O) oestrogens Conjugated Tibolone has both oestrogenic and progestogenic properties. progestogenic and oestrogenic both has Tibolone Approximate dose per 24 h of use of h 24 per dose Approximate O, oestrogen; P, progestogen oestrogen; O, Trisequens ForteTrisequens Oral (O) Oestradiol Trisequens, Triskevens Tridestra Oral (O) valerate Oestradiol Prempro Oral (O) oestrogens Conjugated Premphase Oral (O) oestrogens Conjugated Prempak-C/ Prempak Premique Oral (O) oestrogens Conjugated Nuvelle Oral (O) valerate Oestradiol Table 5 (contd) Table 5 nameDrug Menophase RouteNovafac Oral Composition Oral (O) Mestranol (O) oestrogens Conjugated Dos a b