Pharmacodynamic, pharmacokinetic and safety characteristics of a new contraceptive patch containing ethinyl estradiol and gestodene:
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| Format: | Thesis Book |
| Language: | English |
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2004
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| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Physical Description: | 118 S. graph. Darst. 21 cm |
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| 245 | 1 | 0 | |a Pharmacodynamic, pharmacokinetic and safety characteristics of a new contraceptive patch containing ethinyl estradiol and gestodene |c von Maureen Cronin |
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| adam_text | PHARMACODYNAMIC, PHARMACOKINETIC AND SAFETY CHARACTERISTICS OF A NEW
CONTRACEPTIVE PATCH CONTAINING ETHINYL ESTRADIOL AND GESTODENE
DISSERTATION ZUR ERIANGUNGEN DES AKADEMISCHEN GRADES DOCTOR MEDICINAE
(DR. MED.) VORGELEGT DEM RAT DER MEDIZINISCHEN FAKULTAT DER
FRIEDRICH-SCHILLER-UNIVERSITAT JENA VON MAUREEN CRONIN, B.A. GEBOREN AM
AUGUST 5, 1958 IN MINNEAPOLIS, MINNESOTA TABLE OF CONTENTS 1. SUMMARY 11
2. INTRODUCTION 13 3. STUDY OBJECTIVES 17 4. MATERIALS AND METHODS 20
4.1 BACKGROUND INFORMATION 20 4.2 TEST PREPARATIONS 23 4.2.1 ACTIVE
SUBSTANCES 23 4.2.2 CONTRACEPTIVE PATCH 26 4.2.3 PLACEBO PATCH 28 4.3
STUDY DESIGN 28 4.3.1 PRIMARY TARGET VARIABLES 33 4.3.2 STATISTICAL
ANALYSIS 37 5. RESULTS 38 5.1 STUDY POPULATION 38 5.2 PHARMACODYNAMIC
RESULTS 41 5.2.1 OVARIAN FLS ASSESSMENTS 41 52.2 ENDOGENOUS SERUM
HORMONE CONCENTRATIONS 43 5.2.3 ANALYSIS OF OVARIAN ACTIVITY 48 5.3
PHARMACOKINETIC RESULTS 49 5.3.1 ETHINYL ESTRADIOL SERUM CONCENTRATIONS
50 53.2 GESTODENE SERUM CONCENTRATIONS 52 5.3.3 SHBG SERUM
CONCENTRATIONS 54 5.4 SAFETY RESULTS 55 5.4.1 APPLICATION SITE
TOLERABILITY 56 5.4.2 PATCH ADHESION 60 5.4.3 CYCLE CONTROL 62 6.
DISCUSSION OF THE RESULTS 62 6.1 OVULATION INHIBITION 63 6.2 STUDY DRUG
SERUM CONCENTRATIONS 73 6.3 SAFETY ISSUES 80 6.3.1 PATCH ADHESION 81 7.
CONCLUSIONS 87 8. TABLES AND GRAPHS 91 9. REFERENCES 107 10. ATTACHMENTS
116 TABLE OF TEXT TABLES AND TEXT FIGURES TT 1. ENDOGENOUS E2 AND P
SERUM CONCENTRATIONS AND DAILY PRODUCTION BY LIFE PHASE 21 TT 2: TEST
SUBSTANCES DATA 26 TT 3. CONTRACEPTIVE PATCH DATA 27 TT 4. PLACEBO PATCH
DATA 28 TT5: STUDY MEASURES BY STUDY PHASES 29 TT6: STUDY MEASURES BY
TREATMENT CYCLE DAY 32 TT 7: INTENSITY OF MENSTRUAL BLEEDING 33 TT
8 HOOGLAND OVARIAN ACTIVITY SCORE 34 TT 9: SUMMARY OF THE EE SERUM
CONCENTRATION ANALYSTS PARAMETERS 36 TT 10. PRECISION AND ACCURACY OF
THE GSD ASSAY 37 TT 11: PRECISION AND ACCURACY OF THE SHBG ASSAY 37 TT
12. DEMOGRAPHIC DATA (AGE, WEIGHT, HEIGHT, AND BODY MASS INDEX) 39 TT 13
VITAL SIGNS AT BASELINE (N = 30) 40 TT 14: VOLUNTEERS WITH MAXIMUM E2
CONCENTRATIONS 100PG/ML IN TREATMENT CYCLES 1 OR 2 45 TT 15. MEAN
PHARMACOKINETIC PARAMETERS OF ETHINYL ESTRADIOL (EE) DURING TREATMENT IN
PP DATA SET(N=27) 50 TT 16. MEAN PHARMACOKINETIC PARAMETERS OF GESTODENE
(GSD) DURING TREATMENT IN PP DATA SET (N=27) 52 TT 17. MEAN SHBG SERUM
LEVELS (GEO CV) AND INCREASE FROM PRE-TREATMENT VALUES DURING TREATMENT
PP DATA SET 55 TT 18. SUMMARY OF CYCLE CONTROL PARAMETERS FOR PP DATA
SET 62 TT 19: PERCENTAGE OF SUBJECTS (N) BY OVARIAN ACTIVITY (BASED ONLY
ON P VALUES) AND TREATMENT GROUP DURING THE TWO COMBINED TREATMENT
CYCLES (TEST CYCLE 1 AND 2, EVRA CYCLE 1 AND 3) 69 TT 20: VOLUNTEERS
WITH ELEVATED E2 NOT NOTED IN THE HOOGLAND SCORE 70 TT 21: DATA FROM
TREATMENT CYCLE 2 FOR SEVERAL OVULATION INHIBITION STUDIES WITH 20UGEE
PREPARATIONS 72 TT 22: COMPARISON OF EE AUC AND C MAX OF TEST PATCH
EVRA PATCH AT THE START OF TREATMENT AND DURING STEADY STATE 75 TT 23:
COMPARISON AUC AND CMAX OF EE FROM THE TEST PATCH VERSUS TWO ORAL
PREPARATIONS AT THE START OF TREATMENT AND STEADY STATE 76 TT 24 MEAN
ACCUMULATION FACTOR (R) FOR EE AND GSD DURING TREATMENT WITH SHP00331AA
IN 27 HEALTHY YOUNG WOMEN 77 TT 25: COMPARISON OF GSD AUC AND C MAX OF
TEST PATCH VERSUS TWO ORAL PREPARATIONS AT THE START OF TREATMENT AND
STEADY STATE 78 TF 1. WORK MECHANISM OF HORMONAL CONTRACEPTIVES 22 TF 2:
ETHINYL ESTRADIOL (EE) 24 TF 3. GESTODENE (GSD) 25 TF 4. DESIGN OF
CONTRACEPTIVE PATCH 27 TF 5: DISPOSITION OF VOLUNTEERS 39 TF 6
INDIVIDUAL MAXIMUM FLS SIZE DURING TREATMENT CYCLE 1 FOR PP DATA SET 41
TF 7 1 INDIVIDUAL MAXIMUM FLS SIZE DURING TREATMENT CYCLE 2 (N=27) 42 TF
8: MEAN (SEM) AND INDIVIDUAL E2 CONCENTRATIONS FOR PP DATA SET FOR
TREATMENT CYCLE 1 44 TF 9 MEAN (SEM) AND INDIVIDUAL E2 CONCENTRATIONS
FOR PP DATA SET FOR TREATMENT CYCLE 2 44 TF 10: MEAN (+SEM) AND
INDIVIDUAL P CONCENTRATIONS FOR PP DATA SET FOR TREATMENT CYCLE 1 46 TF
11, MEAN (SEM) AND INDIVIDUAL P CONCENTRATIONS FOR PP DATA SET FOR
TREATMENT CYCLE 2 47 TF 12. MEAN (SEM) FSH CONCENTRATIONS FOR PP DATA
SET FOR TREATMENT CYCLE 1 AND 2 47 TF 13: FREQUENCY OF OVARIAN ACTIVITY
BY TREATMENT CYCLE FOR PP DATA SET 48 TF 14: MEAN SERUM LEVELS OF EE
DURING TWO TREATMENT CYCLES (WEEK 1 AND WEEK 3) FOR PP DATA SET 51 TF
15: MEAN SERUM LEVELS OF GSD DURING TWO TREATMENT CYCLES (WEEK 1 AND
WEEK 3) FOR PP DATA SET 53 TF 16: INTRAINDIVIDUAL CHANGES IN SHBG LEVELS
FOR PP DATA SET DURING TWO TREATMENT CYCLES 54 TF 17: PERCENTAGE OF
VOLUNTEERS (N=28) WITH SKIN CHANGES AT THE END OF PATCH- WEARING DAYS 2,
5, AND 7 FOR SIX CONSECUTIVE PATCH-WEARING PERIODS 57 TF 18 PERCENTAGE
OF VOLUNTEERS (N=28) WITH SKIN CHANGE ACCORDING TO FIRST APPEARANCE AND
DURATION OF OBSERVED SKIN CHANGE FOR EACH PATCH- WEARING PERIOD 58 TF
19: PERCENTAGE OF VOLUNTEERS (N=28) WITH SKIN CHANGES FOR THE SIX
CONSECUTIVE PATCH-WEARING PERIODS BY DURATION OF SKIN CHANGE 59 TF 20
PERCENTAGE OF VOLUNTEERS (N=26) WITH SKIN CHANGES FROM HORMONE AND
PLACEBO PATCHES 60 TF 21: PERCENT OF PATCHES WITH ADHESION PROBLEMS ON
DIFFERENT WEARING DAYS DURING FOUR DIFFERENT WEARING PERIODS (N = 28) 61
TF 22: COMPARISON OF THE OVARIAN ACTIVITY (ACCORDING TO THE HOOGLAND
SCORE) RESULTS FROM SEVERAL STUDIES DURING THE SECOND TREATMENT CYCLE BY
TREATMENT REGIMEN 66 TF 23 MAXIMUM FOLLICLE SIZE AND E2 CONCENTRATION
DURING THE SECOND TREATMENT CYCLE FOR PP DATA SET (N=27) 71 10 TF 24:
MEAN 7-DAY AUC FOR EE BY WEEK AND ADHESION PROBLEMS 82 TF25: MEAN 7-DAY
AUC OF GSD BY WEEK AND ADHESION PROBLEMS 83 TF 26: MAXIMUM FLS AS A
FUNCTION OF 7-DAY AUC OF EE FOR PP DATA SET 83 TF 27: MAXIMUM FLS AS A
FUNCTION OF 7-DAY AUC OF GSD FOR PP DATA SET 84 TF 28: SERUM EE TIME
CURVE AND PATCH ADHESION PROBLEMS FOR VOLUNTEER NO. 8 FOR FOUR
PATCH-WEANNG PERIODS 85 TF 29. MAXIMUM FLS AND PATCH ADHESION PROBLEMS
FOR NO. 8 FOR ENTIRE TREATMENT PERIOD 85 TABLE OF TABLES AND FIGURES T
1: PHARMACODYNAMIC PARAMETERS FOR PP DATA SET 91 T 2: PHARMACODYNAMIC
PARAMETERS FOR VOLUNTEERS EXCLUDED FROM THE PP DATA SET 93 T 3:
ENDOGENOUS HORMONE LEVELS - PER PROTOCOL SET 94 T4: PHARMACOKINETIC
PARAMETERS OF ETHINYL ESTRADIOL FOR WEEK 1 OF CYCLE 1 95 T 5:
PHARMACOKINETIC PARAMETERS OF ETHINYL ESTRADIOL FOR WEEK 3 OF CYCLE 1
DURING TREATMENT 96 T 6: PHARMACOKINETIC PARAMETERS OF ETHINYL ESTRADIOL
FOR WEEK 1 OF CYCLE 2 97 T 7 1 PHARMACOKINETIC PARAMETERS OF ETHINYL
ESTRADIOL FOR WEEK 3 OF CYCLE 2 98 T8: PHARMACOKINETIC PARAMETERS OF GSD
FOR WEEK 1 OF CYCLE 1 99 T9: PHARMACOKINETIC PARAMETERS OF GSD FOR WEEK
3 OF CYCLE 1 100 T 10 PHARMACOKINETIC PARAMETERS OF GSD FOR WEEK 1 OF
CYCLE 2 101 T 11: PHARMACOKINETIC PARAMETERS OF GSD FOR WEEK 3 OF CYCLE
2 102 T 12: MEAN (ARITH. CV) SHBG SERUM LEVELS (NMOL/L) PRIOR TO
TREATMENT BEGIN AND AT THE END OF EACH PATCH-WEARING PERIOD PLUS PERCENT
CHANGE (%) TO PRE-TREATMENT BASELINE FOR PP DATA SET FOR TWO TREATMENT
CYCLES 102 T 13 INDIVIDUAL ADHESION PROBLEMS WITH THE HORMONE CONTAINING
PART OF THE PATCH FOR PP DATA SET 103 F 1: MEAN (SEM) MAXIMUM FLS SIZE
DURING TREATMENT CYCLE 1 FOR PP DATA SET.. . . 104 F2: MEAN (SEM)
MAXIMUM FLS SIZE DURING TREATMENT CYCLE 2 FOR PP DATA SET 104 F 3 SERUM
CONCENTRATIONS OF EE DURING TREATMENT CYCLE 1 (WEEKS 1 AND 3) FOR THE PP
DATA SET 105 F 4 P SERUM CONCENTRATIONS OF EE DURING TREATMENT CYCLE 2
(WEEKS 1 AND 3) FOR THE PP DATA SET 105 F 5: SERUM CONCENTRATIONS OF GSD
DURING TREATMENT CYCLE 1 (WEEKS 1 AND 3) FOR THEPPDATASET 106 F 6 SERUM
CONCENTRATIONS OF GSD DURING TREATMENT CYCLE 2 (WEEKS 1 AND 3) FOR
THEPPDATASET 106
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| spelling | Cronin, Maureen Verfasser aut Pharmacodynamic, pharmacokinetic and safety characteristics of a new contraceptive patch containing ethinyl estradiol and gestodene von Maureen Cronin 2004 118 S. graph. Darst. 21 cm txt rdacontent n rdamedia nc rdacarrier Jena, Univ., Diss., 2004 Empfängnisverhütungsmittel Klinische Pharmakologie Transdermales therapeutisches System (DE-588)4113937-9 Hochschulschrift gnd-content GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=012921049&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Cronin, Maureen Pharmacodynamic, pharmacokinetic and safety characteristics of a new contraceptive patch containing ethinyl estradiol and gestodene Empfängnisverhütungsmittel Klinische Pharmakologie Transdermales therapeutisches System |
| subject_GND | (DE-588)4113937-9 |
| title | Pharmacodynamic, pharmacokinetic and safety characteristics of a new contraceptive patch containing ethinyl estradiol and gestodene |
| title_auth | Pharmacodynamic, pharmacokinetic and safety characteristics of a new contraceptive patch containing ethinyl estradiol and gestodene |
| title_exact_search | Pharmacodynamic, pharmacokinetic and safety characteristics of a new contraceptive patch containing ethinyl estradiol and gestodene |
| title_full | Pharmacodynamic, pharmacokinetic and safety characteristics of a new contraceptive patch containing ethinyl estradiol and gestodene von Maureen Cronin |
| title_fullStr | Pharmacodynamic, pharmacokinetic and safety characteristics of a new contraceptive patch containing ethinyl estradiol and gestodene von Maureen Cronin |
| title_full_unstemmed | Pharmacodynamic, pharmacokinetic and safety characteristics of a new contraceptive patch containing ethinyl estradiol and gestodene von Maureen Cronin |
| title_short | Pharmacodynamic, pharmacokinetic and safety characteristics of a new contraceptive patch containing ethinyl estradiol and gestodene |
| title_sort | pharmacodynamic pharmacokinetic and safety characteristics of a new contraceptive patch containing ethinyl estradiol and gestodene |
| topic | Empfängnisverhütungsmittel Klinische Pharmakologie Transdermales therapeutisches System |
| topic_facet | Empfängnisverhütungsmittel Klinische Pharmakologie Transdermales therapeutisches System Hochschulschrift |
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