Document Detail


A multicenter clinical evaluation of a new monophasic combination: Minulet (gestodene and ethinyl estradiol).
MedLine Citation:
PMID:  2576253     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The safety and efficacy of a low-dose monophasic oral contraceptive (OC) containing a new progestogen, gestodene (GTD), combined with ethinyl estradiol (EE) is being investigated in two ongoing multicenter trails. In this interim analysis, the formulation was found to be effective and well tolerated. Subject compliance was excellent; no pills were missed in 91.2% of the cycles. The number of women who withdrew from the study was low (15%), indicating good subject acceptance. GTD + EE provided optimal cycle control. Of the total number of OC cycles analyzed, spotting occurred in 8.1%, breakthrough bleeding in 1.8%, and both spotting and breakthrough bleeding in 3.3%. The incidence of spotting decreased fairly steadily during OC administration. Amenorrhea occurred in 0.5% of the cycles. There were no unexpected or serious side effects. The incidence of side effects was low and declined with increased duration of OC use. There were no clinically significant changes in weight or blood pressure. Virtually all of the systolic and diastolic blood pressure readings were in the normal range. The results of this interim analysis indicate that the GTD + EE formulation is a safe and reliable contraceptive.
Authors:
R P de Andrade
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study    
Journal Detail:
Title:  International journal of fertility     Volume:  34 Suppl     ISSN:  0020-725X     ISO Abbreviation:  Int. J. Fertil.     Publication Date:  1989 Sep 
Date Detail:
Created Date:  1990-04-10     Completed Date:  1990-04-10     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0374717     Medline TA:  Int J Fertil     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  22-30     Citation Subset:  IM; J    
Affiliation:
Hospital de Clinicas de U.F.P. Curitiba, Brazil.
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Blood Pressure / drug effects
Body Weight / drug effects
Breast / drug effects
Contraceptives, Oral, Combined / adverse effects,  pharmacology
Ethinyl Estradiol / adverse effects,  pharmacology*
Europe
Female
Follow-Up Studies
Headache / chemically induced
Humans
Menstrual Cycle / drug effects*
Molecular Conformation
Molecular Structure
Multicenter Studies as Topic
Nausea / chemically induced
Norpregnenes / adverse effects,  pharmacology*
Patient Compliance
South America
Chemical
Reg. No./Substance:
0/Contraceptives, Oral, Combined; 0/Norpregnenes; 109852-02-0/Femovan; 57-63-6/Ethinyl Estradiol

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


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