Document Detail


The Pregnancy in Polycystic Ovary Syndrome II (PPCOS II) trial: rationale and design of a double-blind randomized trial of clomiphene citrate and letrozole for the treatment of infertility in women with polycystic ovary syndrome.
MedLine Citation:
PMID:  22265923     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Polycystic Ovary Syndrome (PCOS) is a common cause of female infertility and first line treatment is currently oral clomiphene citrate, a selective estrogen receptor modulator, which results in both a high nonresponse rate and multiple pregnancy rate. Aromatase inhibitors such as letrozole may have more favorable ovarian and endometrial effects. The goal of the Pregnancy in Polycystic Ovary Syndrome II (PPCOSII) study is to determine the safety and efficacy of clomiphene citrate (CC) compared to letrozole, in achieving live birth in infertile women with PCOS. The population will consist of 750 infertile women with PCOS. Additionally, the couple will have no other major infertility factor. This will be a multi-center, prospective, double-blind clinical trial of CC vs. letrozole for 5 treatment cycles (or approximately up to 25 weeks). The randomization scheme will be coordinated through the central data coordinating center (DCC) and the randomization is stratified by each participating site. After progestin withdrawal as needed, 750 women will be equally randomized to two different treatment arms: A) CC 50mg every day for 5 days (days 3-7 of cycle), or B) letrozole 2.5mg every day for 5 days (days 3-7 of cycle), for a total of 5 cycles or 25 weeks. The dose will be increased in subsequent cycles in both treatment groups for non-response or poor ovulatory response up to a maximum of 150 mg of CC a day (×5 days) or 7.5mg of letrozole a day (×5 days). The primary analysis will use an intent-to-treat approach to examine differences in the live birth rate in the two treatment arms.
Authors:
Richard S Legro; Allen R Kunselman; Robert G Brzyski; Peter R Casson; Michael P Diamond; William D Schlaff; Gregory M Christman; Christos Coutifaris; Hugh S Taylor; Esther Eisenberg; Nanette Santoro; Heping Zhang;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural     Date:  2012-01-13
Journal Detail:
Title:  Contemporary clinical trials     Volume:  33     ISSN:  1559-2030     ISO Abbreviation:  Contemp Clin Trials     Publication Date:  2012 May 
Date Detail:
Created Date:  2012-03-26     Completed Date:  2012-07-31     Revised Date:  2014-04-30    
Medline Journal Info:
Nlm Unique ID:  101242342     Medline TA:  Contemp Clin Trials     Country:  United States    
Other Details:
Languages:  eng     Pagination:  470-81     Citation Subset:  IM    
Copyright Information:
Copyright © 2012 Elsevier Inc. All rights reserved.
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Antineoplastic Agents / therapeutic use
Chi-Square Distribution
Clomiphene / therapeutic use*
Double-Blind Method
Female
Fertility Agents, Female / therapeutic use*
Health Status Indicators
Hirsutism / drug therapy
Humans
Hyperandrogenism / drug therapy
Infertility, Female / drug therapy*,  etiology
Middle Aged
Nitriles / therapeutic use*
Ovulation Induction / methods*
Polycystic Ovary Syndrome / complications,  drug therapy*
Pregnancy
Quality of Life / psychology
Research Design
Triazoles / therapeutic use*
Women's Health
Young Adult
Grant Support
ID/Acronym/Agency:
C06 RR016499/RR/NCRR NIH HHS; MO1RR10732/RR/NCRR NIH HHS; U10 HD038992-01/HD/NICHD NIH HHS; U10 HD055936/HD/NICHD NIH HHS; U10 HD055936/HD/NICHD NIH HHS; U10 HD055942/HD/NICHD NIH HHS; U10 HD055944/HD/NICHD NIH HHS; U10 HD33172/HD/NICHD NIH HHS; U10 HD38992/HD/NICHD NIH HHS; U10 HD38998/HD/NICHD NIH HHS; U10 HD39005/HD/NICHD NIH HHS; U10HD055925/HD/NICHD NIH HHS; U10HD27049/HD/NICHD NIH HHS; U54-HD29834/HD/NICHD NIH HHS; UL1 TR000127/TR/NCATS NIH HHS
Chemical
Reg. No./Substance:
0/Antineoplastic Agents; 0/Fertility Agents, Female; 0/Nitriles; 0/Triazoles; 112809-51-5/letrozole; 1HRS458QU2/Clomiphene
Investigator
Investigator/Affiliation:
K Barnhart / ; L Martino / ; K Lecks / ; E Puscheck / ; M Singh / ; K Collins / ; M Brossoit / ; A Awonuga / ; T Woodard / ; A Cline / ; L Cedo / ; W C Dodson / ; C Gnatuk / ; S Estes / ; J Ober / ; C Bartlebaugh / ; J Trussell / ; M Crow / ; A King / ; A Hohmann / ; S Mallette / ; R Robinson / ; G Medrano / ; N Budrys / ; C Easton / ; A Hernandez / ; D Pierce / ; M Leija / ; P Gutierrez / ; D Ohl / ; L Vandell / ; H Tang / ; W Bates / ; S Mason / ; S Lucidi / ; M Rhea / ; V Baker / ; K Turner / ; R Usadi / ; N DiMaria / ; H Huang / ; M Zhang / ; L Sakai / ; T Thomas / ; P Patrizio / ; S Tsang /
Comments/Corrections

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


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