| A multicenter clinical evaluation of a new monophasic combination: Minulet (gestodene and ethinyl estradiol). | |
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MedLine Citation:
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PMID: 2576253 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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R P de Andrade |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Multicenter Study |
Journal Detail:
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Title: International journal of fertility Volume: 34 Suppl ISSN: 0020-725X ISO Abbreviation: Int. J. Fertil. Publication Date: 1989 Sep |
Date Detail:
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Created Date: 1990-04-10 Completed Date: 1990-04-10 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 0374717 Medline TA: Int J Fertil Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 22-30 Citation Subset: IM; J |
Affiliation:
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Hospital de Clinicas de U.F.P. Curitiba, Brazil. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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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:
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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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