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Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation

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ClinicalTrials.gov Identifier: NCT01103518
Recruitment Status : Unknown
Verified April 2010 by Fundação Educacional Serra dos Órgãos.
Recruitment status was:  Active, not recruiting
First Posted : April 14, 2010
Last Update Posted : August 6, 2010
Sponsor:
Information provided by:
Fundação Educacional Serra dos Órgãos

Tracking Information
First Submitted Date  ICMJE April 12, 2010
First Posted Date  ICMJE April 14, 2010
Last Update Posted Date August 6, 2010
Study Start Date  ICMJE December 2009
Estimated Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2010)
Regular Menstruation [ Time Frame: Treatment month 3 ]
Percentage of subjects with regular menstruation at the end of treatment month 3
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01103518 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2010)
  • Menstrual flow [ Time Frame: Treatment months 3 ]
    Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 3
  • Menstrual colic [ Time Frame: Treatment month 3 ]
    Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 3.
  • Global self evaluation scores [ Time Frame: Treatment month 6 ]
    Percentage of subjects with scores of 9 and 10 on the self evaluation of global condition.
  • Willingness to continue treatment [ Time Frame: Treatment month 6 ]
    Percentage of subjects willing to continue treatment with study drug
  • Safety [ Time Frame: Treatment and follow-up period ]
    Incidence, duration and severity of adverse events, including laboratory tests.
  • Menstrual Flow [ Time Frame: Treatment month 4 ]
    Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 4
  • Menstrual Flow [ Time Frame: Treatment month 5 ]
    Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 5.
  • Menstrual Colic [ Time Frame: Treatment month 4 ]
    Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 4.
  • Menstrual Colic [ Time Frame: Treatment month 5 ]
    Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 5.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation
Official Title  ICMJE Phase IV Study of the Use of Two Preparations of Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation of Hyper-androgenic Origin
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Amenorrhea
  • Dysmenorrhea
  • Menstruation Disturbances
  • Hyperandrogenism
Intervention  ICMJE Drug: 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.
Study Arms  ICMJE
  • Experimental: Combination 1
    Ethinyl Estradiol + Cyproterone acetate
    Intervention: Drug: Ethinyl Estradiol + Cyproterone acetate
  • Active Comparator: Combination 2
    Ethinyl Estradiol + Cyproterone acetate
    Intervention: Drug: Ethinyl Estradiol + Cyproterone acetate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 13, 2010)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2011
Estimated Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female subject
  • Premenopausal subject
  • 18 years or older
  • Medical history of irregular menses lasting at least 3 months
  • Signature of informed consent

Exclusion Criteria:

  • Pregnancy
  • Use of hormonal contraceptives within 3 months of screening
  • Primary bilateral oophorectomy
  • Chemotherapy and / or radiotherapy within 6 months of screening
  • Hysterectomy
  • Myotonic dystrophy
  • Galactosemia
  • Galactorrhea
  • History of tuberculosis or schistosomiasis
  • Elevated prolactin / other significant laboratory alterations
  • Diabetes
  • Premature ovarian deficiency
  • Sensitivity to any component of the drug formula
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01103518
Other Study ID Numbers  ICMJE AMI 1-16-08-09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Carlos Romualdo Barboza Gama, Fundação Educacional Serra dos Órgãos
Study Sponsor  ICMJE Fundação Educacional Serra dos Órgãos
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carlos RB Gama, M.D. Fundação Educacional Serra dos Órgãos
Study Director: Carlos P Nunes, M.D. Fundação Educacional Serra dos Órgãos
PRS Account Fundação Educacional Serra dos Órgãos
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP