Document Detail


Clinical acceptability of monophasic gestodene.
MedLine Citation:
PMID:  2220965     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The monophasic low-dose contraceptive containing 30 micrograms of ethinyl estradiol and 75 micrograms of gestodene has been tested in numerous clinical studies to determine contraceptive reliability, cycle control, and influence on metabolism and to uncover concomitant symptoms. Clinical data have been derived from continuous phase III studies. Now that the preparation has been introduced in several countries, the opportunity to assemble comprehensive experience has been taken by initiating phase IV studies. Documentation on 600,000 therapy cycles with monophasic gestodene among 100,000 women is already available. The drop-out rate was low. A large number of women participated in the clinical studies for a long time--some up to 3 years. Study results showed that contraceptive reliability was high and cycle control was excellent. The gestodene combination was well tolerated. The frequency of concomitant symptoms was low. The monophasic gestodene meets the basic criteria essential for an oral contraceptive.
Authors:
B Düsterberg; K Brill
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Publication Detail:
Type:  Clinical Trial; Journal Article    
Journal Detail:
Title:  American journal of obstetrics and gynecology     Volume:  163     ISSN:  0002-9378     ISO Abbreviation:  Am. J. Obstet. Gynecol.     Publication Date:  1990 Oct 
Date Detail:
Created Date:  1990-11-19     Completed Date:  1990-11-19     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  0370476     Medline TA:  Am J Obstet Gynecol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1398-404     Citation Subset:  AIM; IM    
Affiliation:
Research Laboratories, Schering AG, Berlin, West Germany.
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MeSH Terms
Descriptor/Qualifier:
Adult
Blood Pressure / drug effects
Body Weight / drug effects
Contraceptives, Oral, Combined* / adverse effects,  chemistry
Drug Evaluation
Ethinyl Estradiol* / adverse effects,  chemistry
Female
Humans
Menstrual Cycle / drug effects
Norpregnenes* / adverse effects,  chemistry
Patient Dropouts
Pregnancy
Chemical
Reg. No./Substance:
0/Contraceptives, Oral, Combined; 0/Norpregnenes; 57-63-6/Ethinyl Estradiol; 60282-87-3/Gestodene

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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