Document Detail


An open-label, multicentre trial to evaluate the vaginal bleeding pattern of the combined contraceptive vaginal ring NuvaRing.
MedLine Citation:
PMID:  18358586     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: The objective of this multicentre, non-controlled, open-label study is the evaluation of the bleeding patterns during the use of a vaginal combined contraceptive, its safety in relation to occurrence of adverse effects, its efficacy as a contraceptive method and user compliance. STUDY DESIGN: Healthy female volunteers (N=165), asking for contraception, were enrolled to participate in the study. Each subject was given seven vaginal rings, releasing an average amount of 120microg etonogestrel (ENG) and 15microg ethinylestradiol (EE) per day. Study period was 7 cycles. A total of 878 cycles was valid for statistical analysis. The primary parameter, (breakthrough bleeding and/or spotting), was recorded for each cycle. The subjects were asked to report any adverse effect experienced during the treatment period, general physical and gynaecological examinations were performed and haematological blood tests were taken. RESULTS: Breakthrough bleeding/spotting occurred in 5.01% cycles (44 out of 878 cycles, of whom 37 were breakthrough spotting only). Absence of withdrawal bleeding during the ring-free period was reported in 1.94% cycles (17 out of 878). Forty-one subjects (24.8%) reported 66 events that were potentially drug-related. The most frequently drug-related events were weight increase (10 cases), headache (9 cases), nausea (4 cases). No pregnancy was reported during the study period. Haematology and chemical chemistry tests showed no clinically significant abnormality. CONCLUSIONS: In the present study, NuvaRing has shown to be a valid contraceptive method to ensure optimal cycle control with low incidence of irregular bleeding and altered withdrawal bleeding. The low incidence of gastrointestinal side effects (nausea, vomiting) may be related the low hormonal dose and to the vaginal delivery of hormones which avoids the gastrointestinal tract.
Authors:
Vincenzina Bruni; Valentina Pontello; Stefano Luisi; Felice Petraglia
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Publication Detail:
Type:  Clinical Trial, Phase III; Journal Article; Multicenter Study     Date:  2008-03-21
Journal Detail:
Title:  European journal of obstetrics, gynecology, and reproductive biology     Volume:  139     ISSN:  0301-2115     ISO Abbreviation:  Eur. J. Obstet. Gynecol. Reprod. Biol.     Publication Date:  2008 Jul 
Date Detail:
Created Date:  2008-07-01     Completed Date:  2008-12-16     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0375672     Medline TA:  Eur J Obstet Gynecol Reprod Biol     Country:  Ireland    
Other Details:
Languages:  eng     Pagination:  65-71     Citation Subset:  IM    
Affiliation:
Obstetrics and Gynaecology Clinic, Careggi Hospital, University of Florence, Florence, Italy.
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Contraceptive Devices, Female / adverse effects*
Contraceptives, Oral, Combined / adverse effects*
Desogestrel / adverse effects,  analogs & derivatives
Drug Combinations
Ethinyl Estradiol / adverse effects
Female
Humans
Metrorrhagia / chemically induced*
Middle Aged
Patient Compliance
Chemical
Reg. No./Substance:
0/Contraceptives, Oral, Combined; 0/Drug Combinations; 0/NuvaRing; 54024-22-5/Desogestrel; 57-63-6/Ethinyl Estradiol

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


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