Phase IV Study of the Use of Two Preparations of Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation of Hyper-androgenic Origin
Sponsor study identifier
interventional
100
1 country
1
Study Start
December 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This is a Phase IV, randomized, double-blind, comparative study of the use of two preparations of ethinyl estradiol and cyproterone acetate in the treatment of menstrual irregularities of hyper-androgenic origin.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2009
Date type not reportedThis date has not been verified as actual or estimated.
April 12, 2010
Actual (reported)April 14, 2010
Actual (reported)November 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Regular Menstruation
Percentage of subjects with regular menstruation at the end of treatment month 3
Treatment month 3
Menstrual flow
Treatment months 3
Menstrual colic
Treatment month 3
Global self evaluation scores
Ethinyl Estradiol + Cyproterone acetate
Ethinyl Estradiol + Cyproterone acetate
Ethinyl Estradiol (0.035mg) + Cyproterone acetate (2mg), coated tablets. Each treatment cycle consists of one tablet, once per day for 21 days followed by a 7-day rest period. A total of 4 treatment cycles will be completed during the study treatment period.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hospital das Clínicas de Teresópolis
Teresópolis, Rio de Janeiro, 25976-016, Brazil
Carlos RB Gama, M.D.
Fundação Educacional Serra dos Órgãos
Carlos P Nunes, M.D.
Fundação Educacional Serra dos Órgãos
First Submitted
April 12, 2010
First Posted
April 14, 2010
Study Start
December 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2010
Estimated (date passed)Treatment month 6
Willingness to continue treatment
Treatment month 6
Safety
Treatment and follow-up period
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 6, 2010
Record last verified: 2010-04
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Source: ClinicalTrials.gov.
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