|
13 documents found matching dt:report-scientific.
|
|
of 2
Prev
Next
|
|
|
|
Showing 1-10 of 13 documents
|
| 1.
Merck Clinical Study Report. Assessment of Differences Between Vioxx and Naproxen to Ascertain Gastrointestinal Tolerability and Effectiveness (ADVANTAGE)
|
| |
2.
sNDA from VIGOR
|
Document Date:
|
20000620
|
|
Search Terms in Context:
|
Reference P088C A Double-Blind. Randomized. Stratified. Parallel-Group Study to
EXHIBIT
«e^S^A B MRK-00420012526
pgNbr=1
154
MK-0966 Prot. No. 088/089 VIGOR
-135-
9.2 Adverse Experiences—Clinical
Most adverse experiences were transient and self-limited. No clinically important differences in the overall incidence of clinical adverse experiences were observed between treatment groups. The overall incidence of discontinuations due to clinical adverse experiences was similar between treatment groups (approximately 16% in both treatment groups). There were significantly more serious adverse experiences on rofecoxib compared with naproxen. There was an increased incidence of serious cardiovascular system adverse experiences. Conversely, there were more serious digestive system adverse experiences on naproxen compared with rofecoxib.
Serious adverse experiences are discussed in Section 9.3. A combined analysis of serious cardiovascular events can be found in [2.1.
|
|
Bookmark:
|
http://dida.library.ucsf.edu/tid/oxx12w10
|
|
| |
3.
Clinical Study Protocol: Comparison of the Cardiovascular Effect of Conjugated Equine Estrogens Plus Medroxyprogesterone Acetate With Those of Raloxifene in Menopausal Women
|
Document Date:
|
19990826
|
|
Page Count:
|
9
|
|
Search Terms in Context:
|
CLINICAL STUDY PROTOCOL
Comparison of the cardiovascular effect of conjugated equine estrogens plus medroxyprogesterone acetate with those of raloxifene
in menopausal women
short title:
TITLE:
Vascular effect of CEE-MPA versus Raloxifene
Comparative effect of conjugated equine estrogens and medroxyprogesterone versus raloxifene upon endothelium-dependent flow-mediated dilatation of the brachial artery and endothelin-1 plasma levels in menopausal women with risk factors for coronary artery disease
PROTOCOL DATE: August 26,1999
INVESTIGATORS:
STUDY CENTER:
SPONSOR:
Giuseppe ROSANO, M.D., Ph.D.
Cristiana Vitale Massimo Fini 'Sandra Zoncu 'Giuseppe Mercuro
ISTITUTO H SAN RAFFAELE Dept of Cardiology Via Elio Chianesi 33 Roma - ITALY Tel. 00 39 06 52401 Fax: 00 39 06 52405003 e-mail: RosanoaliBvahoo.conn
*Dept of Cardiology, University of Gaglian
Caglian - ITALY
Tel. 00 39 070 6028400
Fax 00 39 070 6028401
e-mail; mercuro@pacs,unica it
Wyeth-Ayerst
STATEMENT OF CONFIDENTIALITY
This protocol
|
|
Bookmark:
|
http://dida.library.ucsf.edu/tid/njc37b10
|
|
| |
4.
A study of the control of climacteric symptoms in postmenopausal women following sequential regimens of 1 mg 17 beta-estradiol and trimegestone compared with a regimen containing 1 mg estradiol valerate and norethisterone over a 2-year period
|
Document Date:
|
20050801
|
|
Author:
|
Pornel, B; Spielmann, D; Trimegestone 302 Study Group
|
|
Corporate Author:
|
Brussels Menopause Center; Wyeth R&D
|
|
Page Count:
|
8
|
|
Search Terms in Context:
|
Gynecological Endocrinology, August 2005; 21(2): 74-81
Taylor & Francis
Taylor & Francis Group
TRIMEGESTONE AND MENOPAUSE
A study of the control of climacteric symptoms in postmenopausal women following sequential regimens of 1 mg 17/?-estradiol and trimegestone compared with a regimen containing 1 mg estradiol valerate and norethisterone over a 2-year period
B. PORNEL1, D. SPIELMANN2, & THE TRIMEGESTONE 302 STUDY GROUP
Brussels Menopause Center, Brussels, Belgium, and Wyeth R&D, Paris, France (Received 30 December 2004; accepted 24 March 2005)
Abstract
Objective. To compare the efficacy of two sequential 17/?-estradiol (17/?-E2)/trimegestone (TMG) combinations with the
sequential estradiol valerate (E2V)/norethisterone (NET) regimen in relieving climacteric symptoms.
Study design. This was a double-blind, randomized, multicenter study conducted among 1218 Caucasian (99%)
postmenopausal women with an intact uterus in seven European countries and Israel, over 13 cycles
|
|
Bookmark:
|
http://dida.library.ucsf.edu/tid/vyc37b10
|
|
| |
5.
Efficacy on climacteric symptoms of a continuous combined regimen of 1 mg 17 beta-estradiol and trimegestone versus two regimens containing 1 or 2 mg 17 beta-estradiol and norethisterone acetate
|
Document Date:
|
20050801
|
|
Author:
|
Gambacciani, M; Spielmann, D; Genazzani, AR; Trimegestone 301 Study Group
|
|
Corporate Author:
|
Wyeth R&D; Department of Obstetrics & Gynecology, Piero Fioretti University of Pisa
|
|
Page Count:
|
9
|
|
Search Terms in Context:
|
, Strolley PD, Rosenshein NB, Davies JL, Tonascia JA, Brown C, Burnett L, Rutledge A, Pokempner M, Garcia R. Endometrial cancer and estrogen use. Report of a large case-control study. N Engl J Med, 1979;300:9-13.
2. Cust MP, Gangar KF, Hillard TC, Whitehead MI. A risk-benefit assessment of estrogen therapy in postmenopausal women. Drug Saf 1990;5:345-358.
3. Schiff I, Sela HK, Cramer D
|
|
Bookmark:
|
http://dida.library.ucsf.edu/tid/ryb37b10
|
|
| |
6.
Effects of 1713-estradiol and trimegestone alone, and in combination, on the bone and uterus of ovariectomized rats
|
Document Date:
|
20010101
|
|
Author:
|
Lepescheux, L; Secchi, J; Gaillard-Kelly, M; Miller, P
|
|
Corporate Author:
|
Aventis Pharma
|
|
Page Count:
|
9
|
|
Search Terms in Context:
|
Cynccal Endocrinol 2001;15:312-320
Effects of 1713-estradiol and
trimegestone alone, and in combination, on the bone and uterus of ovariectomized rats
Z- Lepescheux, J. Secchi, M. Gaillard-Kelly and P. Miller
Aventis Pharma. Romainville, France
Key words: 1713-ESTRADIOL, TRIMEGESTONE, BONE, UTERUS, OVARIECTOMIZED RAT
ABSTRACT
Trimegestone is a novel norpregnane progestin, which is being developed, in combination with 170-estradiol,for the treatment of menopausal symptoms and prevention of postmenopausal osteoporosis. A model of osteoporosis in the ovariectomized rat has been used to evaluate the effects ofl 713-estradiol and trimegestone, alone and in combination, on bone and uterus in these animals.
Two treatment protocols were investigated, preventive with treatment starting immediately after ovariectomy and curative with treatment starting 1 or 6 months after o\'ariectomy. 17P-Estradiol was administered subattane-ously at a dose of 10 fig/kg/day with trimegestone or norefhisterone being administere
|
|
Bookmark:
|
http://dida.library.ucsf.edu/tid/ssc37b10
|
|
| |
7.
Assessment of the metabolic tolerance in postmenopausal women over a 1-year period of two hormone replacement therapoies containing estradiol in combination with either norgestrel or trimegestone
|
Document Date:
|
20020101
|
|
Author:
|
Meuwissen, JHJM; Beijers-De Bie, L; Vihtamaki, T; Tuimala, R; Siseles, N; Magaril, C; The, HS; Houben, PWH; Murga, M; Spielmann, D; De Villiers, TJ
|
|
Corporate Author:
|
Diagnostisch Centrum, Eindhoven; Koskiklinikka, Tampere; Hospital Frances-Carlos Calvo; Hospital Ramos Mejia; St Gemini Hospital; Hospital Rivadavia; Wyeth-Ayerst; Panorama Medi-Clinic
|
|
Page Count:
|
8
|
|
Search Terms in Context:
|
Gynecol Endocrinol 2002;16:155-162
Assessment of the metabolic tolerance in postmenopausal
women over a 1-year period of two
hormone replacement therapies
containing estradiol in combination
with either norgestrel or
. trimegestone
o
J3 u H
J. H. J. M. Meuwissen, L. Beijers-De Bie, T. Vihtamaki , R. Tuimala , N. Siseles\ C. Magarit, 3 H. S. The , P. W. H. Houben , M. Murgau, D. Spielmann tt and T.J. De Villiers
*
rt Diagnostisch Centrum, Eindhoven, The Netherlands; Koskiklinikka, Tampere, Finland;
"jf fHospital Frances-Carlos Calvo, Buenos Aires, Argentina; {Hospital Ramos Mejia, Buenos Aires,
i I n n
±! Argentina; St. Gemini Hospital, Den Helder, The Netherlands; ttHospital Rivadavia, Buenos h * * *
y Aires, Argentina; ttWyeth-Ayerst, Paris, France; P
|
|
Bookmark:
|
http://dida.library.ucsf.edu/tid/txb37b10
|
|
| |
8.
A comparative 2-year study of the effects of sequential regimens of 1 mg 17 beta-estradiol and trimegestone with a regimen containing estradiol valerate and norethisterone on the bleeding profile and endometrial safety in postmenopausal women
|
Document Date:
|
20050801
|
|
Author:
|
Koninckx, PR; Spielmann, D; Trimegestone 302 Study Group
|
|
Corporate Author:
|
University Hospital Gasthuisberg; Wyeth R&D
|
|
Page Count:
|
8
|
|
Search Terms in Context:
|
Gynecological Endocrinology, August 2005; 21(2): 82-89 A^ Taylor & Francis
TRIMEGESTONE AND MENOPAUSE
A comparative 2-year study of the effects of sequential regimens of 1 mg 17/?-estradiol and trimegestone with a regimen containing estradiol valerate and norethisterone on the bleeding profile and endometrial safety in postmenopausal women
P. R. KONINCKX1, D. SPIELMANN2, & THE TRIMEGESTONE 302 STUDY GROUP
University Hospital Gasthuisberg, Kuleuven, Belgium, and Wyeth R&D, Paris, France
Abstract
Objective. To compare the bleeding profiles and endometrial protection of two sequential regimens of 17^-estradiol (17/S-E2) and trimegestone (TMG) with a sequential estradiol valerate (E2V)/norethisterone (NET) regimen. Study design. This was a randomized, double-blind, multicenter study conducted in eight countries in healthy, postmenopausal women with an intact uterus. A total of 1218 women were enrolled into the initial 1-year study (13 cycle
|
|
Bookmark:
|
http://dida.library.ucsf.edu/tid/sob37b10
|
|
| |
9.
A comparison of the effects of continuous combined regimens of 1 mg 17 beta-estradiol and trimegestone with regimens containing 1 or 2 mg 17 beta-estradiol and norethisterone acetate upon the bleeding profile and endometrial safety in postmenopausal women
|
Document Date:
|
20030101
|
|
Author:
|
Bouchard, P; Addo, S; Spielmann, D; Trimegestone 301 Study Group
|
|
Corporate Author:
|
Hopital St. Antoine; Bourn Hall Clinic; Wyeth R&D
|
|
Page Count:
|
19
|
|
Search Terms in Context:
|
A comparison of the effects of continuous combined regimens of 1 mg 17p-estradiol and trimegestone with regimens containing 1 or 2 mg 17p-estradiol and norethisterone acetate upon the bleeding profile and endometrial safety in postmenopausal women
P. Bouchard, S. Addo*, D. SpielmannT and the Trimegestone 301 Study Group
Hopital St. Antoine, Paris, France; *Bourn Hall Clinic, Bourn, UK; TWyeth R&D, Paris, France
Keywords: Trimegestone, Estradiol, Norethisterone acetate, Continuous combined hormone replacement therapy, Menopause, Bleeding profile, Endometrial safety, Amenorrhea
ABSTRACT
Objective This double-blind, randomized, multi-center study compared the bleeding profile and endometrial safety of a continuous regimen containing 1 mg 17p-estradiol (17p-E2) and 0.125 mg trimegestone (TMG) with those of two hormone therapies containing 17p-E2 and norethisterone acetate (NETA). Method The study was conducted over a 2-year period, with up to 26 cycles of treatment, each of 28 days. Treatment consisted of on
|
|
Bookmark:
|
http://dida.library.ucsf.edu/tid/apb37b10
|
|
| |
10.
Bleeding profile and endometrial safety of continuous combined regimens 1 mg 17 beta-estradiol/trimegestone versus 1 or 2 mg 17 beta-estradiol/norethisterone acetate in postmenopausal women
|
Document Date:
|
20050901
|
|
Author:
|
Bouchard, P; De Cicco-Nardone, F; Spielmann, D; Garcea, N; Trimegestone 301 study group
|
|
Corporate Author:
|
Hpoital St-Antoine; Universita Cattolica del Sacro Cuore; Wyeth R&D; Az. Osp S. Giovanni
|
|
Page Count:
|
6
|
|
Search Terms in Context:
|
equine estrogens and medroxyprogesterone acetate: two year sub-study results. Fertil Steril 2003;80:1234-1240.
30. Sardo AD, Radhakrishnan S. Endometrial carcinoma on continuous combined HRT: case report and literature review. Maturitas 2004;48:171-175.
pgNbr=6
|
|
Bookmark:
|
http://dida.library.ucsf.edu/tid/afc37b10
|
|
| |
|
Prev
Next
|
